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Fibromyalgia
Impact Questionnaire (FIQ) References with Abstracts from 1991
to 2008
(1) de Andrade SC, de Carvalho RF, Soares AS, de Abreu
Freitas RP, de Medeiros Guerra LM, Vilar MJ. Thalassotherapy for
fibromyalgia: a randomized controlled trial comparing aquatic
exercises in sea water and water pool. Rheumatol Int 2008; .
Abstract: The aim of this study was to evaluate the
effectiveness of aerobic exercise in water pool compared with
aerobic exercise performed in sea by women with fibromyalgia
(FM). A total of 46 patients were randomly allocated into two
groups: pool group (23 patients) and sea group (23 patients)
that performed the same aerobic exercise program. Patients were
evaluated baseline and after 12 weeks using: VAS, number of
tender points, FIQ, SF-36, PSQI, and BDI. Both groups improved
significantly in post-treatment for all the evaluated variables.
There were no significant differences between two groups, except
for BDI (F = 2.418, P < 0.0001). Aerobic exercise program
performed in water (pool or sea) was effective for patients with
FM. However, sea water exercises have been shown to bring more
advantages related to emotional aspects. Then, exercise
performed sea water (thalassotherapy) is an option for effective
treatment with low cost for patients with FM
(2) Bigatti SM, Hernandez AM, Cronan TA, Rand KL.
Sleep disturbances in fibromyalgia syndrome: relationship to
pain and depression. Arthritis Rheum 2008; 59(7):961-7.
Abstract: OBJECTIVE: This study is an examination of sleep,
pain, depression, and physical functioning at baseline and
1-year followup among patients with fibromyalgia syndrome (FMS).
Although it is clear that these symptoms are prevalent among FMS
patients and that they are related, the direction of the
relationship is unclear. We sought to identify and report sleep
problems in this population and to examine their relationship to
pain, depression, and physical functioning. METHODS: Patients
diagnosed with fibromyalgia were recruited from a Southern
California health maintenance organization and evaluated
according to American College of Rheumatology criteria in the
research laboratory. Six hundred patients completed the baseline
assessment and 492 completed the 1-year assessment. Measures
included the Center for Epidemiologic Studies Depression Scale,
the McGill Pain Questionnaire, the Pittsburgh Sleep Quality
Index, and the Fibromyalgia Impact Questionnaire. RESULTS: The
majority of the sample (96% at baseline and 94.7% at 1 year)
scored within the range of problem sleepers. Path analyses
examined the impact of baseline values on 1-year values for each
of the 4 variables. No variable of interest predicted sleep,
sleep predicted pain (beta = 0.13), pain predicted physical
functioning (beta = -0.13), and physical functioning predicted
depression (beta = -0.10). CONCLUSION: These findings highlight
the high prevalence of sleep problems in this population and
suggest that they play a critical role in exacerbating FMS
symptoms. Furthermore, they support limited existing findings
that sleep predicts subsequent pain in this population, but also
extend the literature, suggesting that sleep may be related to
depression through pain and physical functioning
(3) Mease PJ, Arnold LM, Crofford LJ, Williams DA,
Russell IJ, Humphrey L et al. Identifying the clinical domains
of fibromyalgia: contributions from clinician and patient delphi
exercises. Arthritis Rheum 2008; 59(7):952-60.
Abstract: OBJECTIVE: In evaluating the effectiveness of
fibromyalgia (FM) therapies, it is important to assess the
impact of those therapies on the full array of domains
considered important by both clinicians and patients. The
objective of this research was to identify and prioritize the
key clinically relevant and important domains impacted by FM
that should be evaluated by outcome assessment instruments used
in FM clinical trials, and to approach consensus among
clinicians and patients on the priority of those domains to be
assessed in clinical care and research. METHODS: Group consensus
was achieved using the Delphi method, a structured process of
consensus building via questionnaires together with systematic
and controlled opinion feedback. The Delphi exercises involved
23 clinicians with expertise in FM and 100 patients with FM as
defined by American College of Rheumatology criteria. RESULTS:
The Delphi exercise revealed that the domains ranked most highly
by patients were similar to the domain rankings by clinicians.
Pain was consistently ranked highest by both panels. Fatigue,
impact on sleep, health-related quality of life, comorbid
depression, and cognitive difficulty were also ranked highly.
Stiffness was ranked highly by patients but not clinicians. In
contrast, side effects was important to clinicians but was not
identified as important in the patient Delphi exercise.
CONCLUSION: The clinician and patient Delphi exercises
identified and ranked key domains that need to be assessed in FM
research. Based on these results, a conceptual framework for
measuring patient-reported outcomes is proposed
(4) Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP,
Jr., Sharma U et al. A 14-week, Randomized, Double-Blinded,
Placebo-Controlled Monotherapy Trial of Pregabalin in Patients
With Fibromyalgia. J Pain 2008; .
Abstract: The purpose of the study was to assess the efficacy
and safety of pregabalin monotherapy in patients with
fibromyalgia in a randomized, double-blinded, placebo-controlled
trial. After 1 week of single-blinded administration of placebo,
750 patients meeting American College of Rheumatology criteria
for fibromyalgia were randomly assigned to pregabalin (300 mg/d,
450 mg/d, 600 mg/d) or placebo, administered twice daily for 14
weeks. The primary outcome variable was comparison of end point
mean pain scores, derived from daily diary ratings of pain
intensity (0 to 10 scale), between each of the pregabalin groups
and the placebo group. If positive, additional primary efficacy
parameters included the Patient Global Impression of Change (PGIC)
and the Fibromyalgia Impact Questionnaire (FIQ) total score.
Compared with placebo-treated patients, mean changes in pain
scores at the end point in pregabalin-treated patients were
significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d,
-0.98; 600 mg/d, -1.00). Compared with placebo, significantly
more pregabalin-treated patients reported improvement on PGIC (P
< .01 for all 3 pregabalin doses) and significant improvements
in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d
(P = .003) doses. Compared with placebo, all 3 doses of
pregabalin were associated with significant improvement in
sleep. The most commonly reported pregabalin-related adverse
events were dizziness and somnolence, which tended to be
dose-related. PERSPECTIVE: This randomized, placebo-controlled
trial of 300, 450, and 600 mg/d of pregabalin monotherapy
demonstrated that all 3 doses were efficacious for up to 14
weeks for the treatment of fibromyalgia and were well tolerated
by most patients. These results provide evidence that pregabalin
is an important treatment option for patients with fibromyalgia
(5) Staud R, Koo EB. Are cannabinoids a new treatment
option for pain in patients with fibromyalgia? Nat Clin Pract
Rheumatol 2008; 4(7):348-9.
Abstract: Preliminary studies suggest that the synthetic
cannabinoid nabilone might be an effective therapy in patients
with fibromyalgia. Skrabek et al. performed a double-blind,
randomized, placebo-controlled clinical trial to analyze the
effects of nabilone on pain and quality of life in patients with
fibromyalgia. After 4 weeks of treatment (0.5 mg once daily in
week 1, 0.5 mg twice daily in week 2, 0.5 mg in the morning and
1 mg in the evening in week 3, and 1 mg twice daily in week 4),
patients who received nabilone (n = 15) experienced significant
improvements in clinical pain, measured on a visual analog scale
(P <0.02), Fibromyalgia Impact Questionnaire score (P <0.02) and
the 10-point anxiety scale of the Fibromyalgia Impact
Questionnaire (P <0.02). After a 4-week wash-out period at the
end of the trial, all benefits were lost in the nabilone cohort,
which returned to their baseline levels of pain and quality of
life. Patients who received placebo (n = 18) experienced no
change throughout the study. Although nabilone was not
associated with serious adverse effects, some patients did
experience drowsiness, dry mouth, vertigo and ataxia as a result
of treatment
(6) Sendur OF, Tastaban E, Turan Y, Ulman C. The
relationship between serum trace element levels and clinical
parameters in patients with fibromyalgia. Rheumatol Int 2008; .
Abstract: We examined the association between serum trace
elements and clinical findings such as number of sensitive
tender points, severity of fatigue and functional status in
patients with fibromyalgia (FM). Thirty-two patients diagnosed
as having FM according to the ACR 1990 criteria and 32 normal
healthy controls (NHC) were included in this study. The
demographic data, disease duration, number of tender points and
accompanying symptoms (fatigue, sleep disorders, headache,
paresthesia, irritable bowel syndrome, sicca symptoms, Raynaud's
phenomena) of the patients were noted. Visual analog scale (10
cm) was implemented to estimate daily severity of pain and
fatigue. Fibromyalgia impact questionnaire was used for
functional assessment. Serum selenium (mug/dL) and serum zinc
(mug/dL) levels were measured by atomic absorption spectrometer.
Serum magnesium (mmol/L) level was measured by the original kits
of Abbott Aeroset auto-analyzer. The mean age of patients in FM
group and NHC were calculated as 42.9 (SD = 7.7) years and 41.3
(SD = 9.7) years, respectively. Serum levels of zinc (P = 0.001)
and magnesium (P = 0.002) were significantly decreased by FM
groups, whereas there was no considerable difference with
selenium levels of both groups (P > 0.05). Association between
serum zinc level and number of tender points (P = 0.008) and
that between fatigue and magnesium level (P = 0.003) was found
as meaningful. According to the results of this study, it was
asserted that serum magnesium and zinc levels may play an
important role in the pathophysiology of FM
(7) Emad Y, Ragab Y, Zeinhom F, El-Khouly G, bou-Zeid
A, Rasker JJ. Hippocampus Dysfunction May Explain Symptoms of
Fibromyalgia Syndrome. A Study with Single-Voxel Magnetic
Resonance Spectroscopy. J Rheumatol 2008; 35(7):1371-7.
Abstract: OBJECTIVE: (1) To investigate dysfunction of
hippocampus in patients with fibromyalgia syndrome (FM) using
proton magnetic resonance spectroscopy (1H-MRS), and to compare
these findings with healthy controls. (2) To correlate levels of
metabolites obtained with aspects of cognition, depression, and
sleep symptoms in the patient group. METHODS: The case-control
study was performed in 15 female patients, who met American
College of Rheumatology criteria for classification of FM, and
10 healthy age-matched female controls. Patients and controls
were receiving no medications known to affect cognitive
functioning or central nervous system metabolites before their
participation in the study. In all patients and controls, 1H-MRS
was used to assess N-acetylaspartate (NAA), choline (Cho),
creatine (Cr), and their ratios from both hippocampi. Levels of
metabolites and their ratios were determined and the findings
compared between the groups. All patients and controls underwent
psychological assessment to assess cognitive function,
depression, and structured sleep interview with sleep diary;
Fibromyalgia Impact Questionnaire (FIQ), number of tender
points, and visual analog scale (VAS) for pain were assessed in
all patients. RESULTS: NAA levels of right and left hippocampi
differed significantly between patients and controls (p < 0.05).
Cho levels in the right hippocampus were higher in the patient
group than in controls (p = 0.005), while no differences were
found with respect to Cr levels in both hippocampi. NAA/Cho and
NAA/Cr ratios differed significantly between patients and
controls (p <0.05), while the Cho/Cr ratio showed no
differences. Significant correlations were found between
language score and right Cho and right Cr levels (p = 0.041, p =
0.006, respectively), while no significant correlations were
found between metabolites and their ratios with FIQ, VAS for
pain, or number of tender points. CONCLUSION: The hippocampus
was dysfunctional in patients with FM, as shown by lower NAA
levels compared to controls, representing neuronal or axonal
metabolic dysfunction. As the hippocampus plays crucial roles in
maintenance of cognitive functions, sleep regulation, and pain
perception, we suggest that metabolic dysfunction of hippocampus
may be implicated in the appearance of these symptoms associated
with this puzzling syndrome
(8) Rau J, Ehlebracht-Konig I, Petermann F. [Impact of
a motivational intervention on coping with chronic pain :
Results of a controlled efficacy study.]. Schmerz 2008; .
Abstract: BACKGROUND: For effective self-management of chronic
pain changes of cognitive and behavioral attitudes are required.
The readiness to change can be described within the framework of
the transtheoretical model (TTM) and is facilitated through
motivational interviewing. This prospective study evaluated the
effectiveness of brief motivational interviewing by telephone
for the variables self-efficacy, cognitive and behavioral coping
and psychological strain through chronic pain over a period of 9
months. METHODS: Different questionnaires, the self-efficacy
expectations (ASES-D), cognitive, behavioral coping and
psychological strain through chronic pain (FESV) and the German
version of the pain stages of change questionnaires (PSOCQ), the
FF-STABS were distributed to 147 patients at a rehabilitation
clinic (indications: fibromyalgia syndrome, rheumatoid
arthritis, ankylosing spondylitis). The intervention group
participants received 3 telephone calls at intervals of 2 months
with a follow-up time of 9 months after first study admission.
At the end of the study 91 patients were enrolled for analysis
(drop out rate 38%). To evaluate the effects of treatment
nonparametric-analysis for longitudinal data was used. RESULTS
AND CONCLUSION: The analysis showed significant positive effects
in the intervention group for cognitive coping (U-value -2.423;
p=0.015 group x time-effect) and for coping with emotional
strains of chronic pain (subscale anxiety: U-value -2.3618;
p=0.018; subscale anger: U-value 2.8638; p=0.004; group x
time-effect). No significant effects were shown for
self-efficacy expectations and behavioral coping with pain.
Further explorative analysis of subgroups revealed slightly
better treatment effects for patients with rheumatoid arthritis
and ankylosing spondylitis than for those with fibromyalgia
syndrome
(9) Rodero B, Garcia J, Casanueva B, Sobradiel N.
Imagined exposure as treatment of catastrophizing in
fibromyalgia. A pilot study. Actas Esp Psiquiatr 2008;
36(4):223-6.
Abstract: Introduction. We want to assess the effectiveness of a
new approach (imagined exposure) for the Cognitive Behavioural
Treatment (CBT) in fibromyalgia. Study design.
Quasi-experimental design of a temporary nature in a single
group with pre and post and with/without treatment. Subjects and
methods. Fibromyalgia (FM) patients, who met the American
College of Rheumatology's criteria for FM. In this study eight
people took part, seven females and one male, selected from FM
Cantabria Association. The CBT consisted of 11 group sessions
and lasted 15 weeks. All patients were evaluated before and
after the program. The data were based on the following scales:
visual-analog scale (VAS) for pain intensity, the Fibromyalgia
Impact Questionnaire (FIQ), the Pain Catastrophizing Scale (PCS)
and the Hospital Anxiety and Depression Scale (HADS). Results.
Despite finding improvements in every variable, no significant
differences were found between pre and postreatment in VAS, HADS
and FIQ. However, after treatment, significant differences were
found in PCS (p 0.05), and its three subscales. Moreover, rate
decrease in rumination was higher after imagined exposure.
Conclusion. These results suggest that CBT is effective either
in catastrophizing decreasing or in rumination. Imagined
exposure may enhance the results in particular cases. Further
studies with larger samples are needed to confirm these results.
Key words: Pain. Catastrophizing. Rumination. Cognitive-behavioural
therapy. Actas Esp Psiquiatr 2008;36(4):223-226
(10) Miller A, Doll H, David J, Wass J. Impact of
musculoskeletal disease on quality of life in long-standing
acromegaly. Eur J Endocrinol 2008; 158(5):587-93.
Abstract: OBJECTIVE: To provide rheumatological assessment of
patients with long-standing acromegaly and investigate the
impact of musculoskeletal disease on quality of life. DESIGN:
Cross-sectional observational study. METHODS: Fifty-eight
patients diagnosed with acromegaly at least 5 years previously
were interviewed and examined by a rheumatologist. Each patient
completed the short form-36 (SF-36), arthritis impact
measurement scales 2 (AIMS2) and acromegaly quality of life
questionnaires (AcroQol). RESULTS: Fifty-two out of 58 (90%)
reported musculoskeletal pain, with 29 (50%) reporting neck
pain. Hip osteoarthritis was present in 49 (84%) and knee
osteoarthritis in 20 (34%). Half the patients (52%) reported
sleep disturbance, but only 2 (3.5%) had fibromyalgia. Ten
(17.2%) had previously undergone carpal tunnel decompression.
Fifty-one (88%) patients had consulted their general practioner
and 31 (54%) complementary therapists. SF-36, AIMS2 and AcroQol
scores were lower in patients with musculoskeletal pain.
CONCLUSIONS: This study of musculoskeletal problems in patients
with acromegaly reports systematic rheumatological examination,
use of medical services and quality of life scores.
Musculoskeletal problems should be routinely addressed in
acromegaly by both endocrinologist and rheumatologist and a
multidisciplinary approach taken to management
(11) Pamuk GE, Pamuk ON, Set T, Harmandar O, Yesil N. An
increased prevalence of fibromyalgia in iron deficiency anemia
and thalassemia minor and associated factors. Clin Rheumatol
2008; .
Abstract: In this study, we evaluated the prevalence of
fibromyalgia (FM) in iron deficiency anemia (IDA) and
thalassemia minor (TM) patients and associated factors. In
addition, we investigated the prevalence of IDA in outpatients
with fibromyalgia, and its effect on clinical findings. The
study included 205 IDA, 40 TM patients and 100 healthy controls.
FM was diagnosed according to 1990 ACR criteria. Whole blood
count, biochemical tests, and serum iron parameters were
determined. Pain, fatigue, and FM Impact Questionnaire (FIQ)
functional item scores were assessed in FM subjects. In
addition, the prevalence of IDA in FM patients diagnosed at the
Rheumatology Outpatient Clinic was determined. The prevalences
of FM in IDA (17.6%) and TM (20%) groups were higher than in
controls (6%; p values 0.006 and 0.025, respectively). When IDA
patients with FM were compared to those without FM, it was seen
that a higher percentage were females, married, and a higher
percentage had history of pica (all p values < 0.05). Serum
hemoglobin and iron parameters did not differ between IDA
patients with and without FM. IDA was detected in 48 (24.5%) of
196 FM patients. FM patients without IDA had higher sleep
disturbance scores (p = 0.012) and longer duration of FM (p =
0.045). FM was a common finding in patients with IDA and TM. FM
was associated with female sex and history of pica in IDA
patients, and not associated with serum hemoglobin and selected
iron parameters. The presence of FM in TM had no association
with any of the above-mentioned parameters
(12) Eyigor S, Ozdedeli S, Durmaz B. The prevalence of
generalized soft tissue rheumatic conditions in Turkish medical
students. J Clin Rheumatol 2008; 14(2):65-8.
Abstract: OBJECTIVE: To assess the prevalence of generalized
soft tissue rheumatism (GSTR) in medical students in Izmir,
Turkey. METHODS: Medical students from each grade of Medical
School of Ege University, Izmir, Turkey, were evaluated by a
survey and physical examination for GSTR including fibromyalgia
(FM) syndrome, myofascial pain syndrome (MPS), benign joint
hypermobility syndrome (BJHS), and chronic fatigue syndrome. FM
Impact Questionnaire was assessed in FM diagnosed students.
Short Form-36 (SF-36) was obtained from each student to
determine the quality of life. RESULTS: Among the participants
(n = 306), 191 were women (62.4%) and 115 were men (37.6%) and
mean age was 20.23 +/- 1.56. Fifty-eight students (19%) were
diagnosed with a GSTR. The distributions of the diagnoses were:
6 (2%) FM, 21 (6.9%) MPS, 28 (9.2%) BJHS, 1 (0.3%) chronic
fatigue syndrome, and 2 students (0.7%) had both BJHS and MPS.
Fifty-three (27.7%) women and 5 (4.3%) men were diagnosed with a
GSTR (P < 0.01). Mean FM Impact Questionnaire score was 50.8 in
FM diagnosed students. Physical role, vitality, and mental
subscores of SF-36 were significantly lower in the students
having a GSTR (P < 0.05). CONCLUSION: This is the first study
performed in medical students to find out the prevalence of
generalized soft tissue rheumatic conditions. Although medical
students are under high stress due to hard training, the
prevalence of GSTR in medical students was found similar to
previous reports in the general population
(13) Tomas-Carus P, Gusi N, Hakkinen A, Hakkinen K, Leal
A, Ortega-Alonso A. Eight months of physical training in warm
water improves physical and mental health in women with
fibromyalgia: a randomized controlled trial. J Rehabil Med 2008;
40(4):248-52.
Abstract: OBJECTIVE: To evaluate the feasibility of 8 months of
supervised exercise therapy in warm water and its effects on the
impact of fibromyalgia on physical and mental health and
physical fitness in affected women. METHODS: Thirty women with
fibromyalgia were randomly assigned to an exercise therapy group
(n = 15) or a control group (inactive) (n = 15). The impact of
fibromyalgia on physical and mental health was assessed using
the Fibromyalgia Impact Questionnaire and the anxiety state with
State-Trait Anxiety Inventory. Physical fitness was measured
using the following tests: Canadian Aerobic Fitness; hand-grip
dynamometry; 10-metre walking; 10-step stair-climbing and blind
1-leg stance. RESULTS: After 8 months of training, the exercise
therapy group improved compared with the control group in terms
of physical function (20%), pain (8%), stiffness (53%), anxiety
(41%), depression (27%), Fibromyalgia Impact Questionnaire total
scores (18%), State-Trait Anxiety Inventory score (22%), aerobic
capacity (22%), balance (30%), functional capacity for walking
(6%), stair-climbing with no extra weight (14%) and
stair-climbing 10 kg-weighted (25%). CONCLUSION: Eight months of
supervised exercise in warm water was feasible and led to
long-term improvements in physical and mental health in patients
with fibromyalgia at a similar magnitude to those of shorter
therapy programmes
(14) Holtgrefe K, McCloy C, Rome L. Changes associated
with a quota-based approach on a walking program for individuals
with fibromyalgia. J Orthop Sports Phys Ther 2007;
37(12):717-24.
Abstract: STUDY DESIGN: Single-subject, multiple-baseline design
across 3 subjects. OBJECTIVE: To investigate the use of a
quota-based approach to prescribing a walking program for
individuals with fibromyalgia (FM). BACKGROUND: Exercise has
been found to be beneficial for individuals with FM. What has
not been determined is the best way to implement an exercise
program that does not increase FM symptoms. METHODS AND
MEASURES: Three women with FM were randomly assigned a baseline
period of 5, 6, or 7 weeks, which served as the control phase,
followed by an intervention period consisting of an 8-week
walking program. The walking program progression was prescribed
using a quota-based approach. Weekly outcome measures were the
Fibromyalgia Impact Questionnaire (FIQ), Arthritis Self-Efficacy
Scale (ASES), and SF-36v2 (acute). A 6-minute walk test was
recorded twice: at the start of the baseline phase (after a
trial phase) and at the end of the intervention phase. RESULTS:
Subjects 1 and 3 had a significant decrease in the symptoms
associated with FM during the intervention phase (FIQ, P<.05),
but no significant increase in self-efficacy (ASES). They
increased their walking distances used for exercise by 640 and
480 m, respectively. Subject 2 had no significant improvements
in her symptoms of FM. Despite a significant decrease in ASES
(P<.05), walking distance used for exercise by subject 2
increased by 2080 m. Six-minute walk test distances increased
76, 32, and 106 m for subjects 1, 2, and 3, respectively.
CONCLUSIONS: Prescribing a walking program using a quota-based
exercise prescription resulted in increasing the distance walked
for 3 subjects. It also decreased symptoms associated with FM in
2 of the 3 subjects, but did not increase self-efficacy
(15) Tander B, Cengiz K, Alayli G, Ilhanli I, Canbaz S,
Canturk F. A comparative evaluation of health related quality of
life and depression in patients with fibromyalgia syndrome and
rheumatoid arthritis. Rheumatol Int 2008; 28(9):859-65.
Abstract: The aim of this study was to compare health related
quality of life (HRQoL) and assess functional and psychological
status in rheumatoid arthritis (RA), fibromyalgia syndrome (FS)
patients and controls (each 30 subjects). Demographic
characteristics, pain and sleep disturbance by Visual Analog
Scale, depression by Beck Depression Inventory (BDI), disease
impact by fibromyalgia impact questionnaire, DAS-28, and HRQoL
by SF-36 were gathered. The FS group scored significantly worser
than the RA group with respect to physical role, social
functioning and bodily pain subscales of SF-36. The scores of
all SF-36 subscales were significantly lower in FS and RA
patients than controls except mental health score. All of the
subscales of SF-36 were negatively correlated with BDI scores in
FS patients. In RA group, the DAS-28 scores were inversely
correlated with all of SF-36 subscales. In conclusion, presence
of comorbid depression must be taken into account when
determining HRQoL in FS and RA. Essentials improving the HRQoL
are management of depression in FS and control of disease
activity in RA
(16) Mease PJ, Russell IJ, Arnold LM, Florian H, Young
JP, Jr., Martin SA et al. A randomized, double-blind,
placebo-controlled, phase III trial of pregabalin in the
treatment of patients with fibromyalgia. J Rheumatol 2008;
35(3):502-14.
Abstract: OBJECTIVE: To evaluate the efficacy and safety of
pregabalin for symptomatic relief of pain associated with
fibromyalgia (FM) and for management of FM. METHODS: This
multicenter, double-blind, placebo-controlled trial randomly
assigned 748 patients with FM to receive placebo or pregabalin
300, 450, or 600 mg/day (dosed twice daily) for 13 weeks. The
primary outcome variable for study objective 1, symptomatic
relief of pain associated with FM, was comparison of endpoint
mean pain scores between each pregabalin group and placebo. The
outcome variable for study objective 2, management of FM,
included endpoint mean pain scores, Patient Global Impression of
Change (PGIC), and Fibromyalgia Impact Questionnaire (FIQ)-Total
Score. Secondary outcomes included assessments of sleep,
fatigue, and mood disturbance. RESULTS: Patients in all
pregabalin groups showed statistically significant improvement
in endpoint mean pain score and in PGIC response compared with
placebo. Improvements in FIQ-Total Score for the pregabalin
groups were numerically but not significantly greater than those
for the placebo group. Compared with placebo, all pregabalin
treatment groups showed statistically significant improvement in
assessments of sleep and in patients' impressions of their
global improvement. Dizziness and somnolence were the most
frequently reported adverse events. CONCLUSION: Pregabalin at
300, 450, and 600 mg/day was efficacious and safe for treatment
of pain associated with FM. Pregabalin monotherapy provides
clinically meaningful benefit to patients with FM
(17) Evcik D, Yigit I, Pusak H, Kavuncu V. Effectiveness
of aquatic therapy in the treatment of fibromyalgia syndrome: a
randomized controlled open study. Rheumatol Int 2008;
28(9):885-90.
Abstract: The aim of this study was to investigate the efficacy
of aquatic exercises in fibromyalgia syndrome (FMS). A total of
63 patients were included and allocated to two groups. Group I
(n = 33) received an aquatic exercise program and Group II (n =
30) received a home-based exercise program for 60 min, 3x a
week, over 5 weeks. Patients were evaluated for pain (visual
analogue scale, VAS), number of tender points (NTP), Beck
depression inventory (BDI), and functional capacity (fibromyalgia
impact questionnaire, FIQ). All assessment parameters were
measured at baseline, and at weeks 4, 12, and 24. There were
statistically significant differences in FIQ and NTP in both
groups at the end and during follow-up (P < 0.05). Group I
showed a statistically significant decrease in BDI scores after
4 and 12 weeks (P < 0.05) that remained after 24 weeks (P <
0.001). In Group II, a significant decrease in BDI scores was
observed at the end and during follow-up (P < 0.001). Also, a
significant improvement was found in VAS at weeks 4 and 12 in
both groups (P < 0.001). The average of reduction in pain scores
was 40% in Group1 and 21% in Group II. However, this was still
significant at week 24 only in the aquatic therapy group. A
comparison of the two groups showed no statistically significant
difference for FIQ, NTP, and BDI scores except VAS (P < 0.001)
Our results showed that both aquatic therapy and home-based
exercise programs have beneficial effects on FIQ, BDI, and NTP.
In pain management, only aquatic therapy seems to have long-term
effects
(18) Couto CI, Natour J, Carvalho AB. Fibromyalgia: its
prevalence and impact on the quality of life on a hemodialyzed
population. Hemodial Int 2008; 12(1):66-72.
Abstract: Fibromyalgia syndrome (FMS) is characterized by
widespread musculoskeletal pain. It has negative effects on
quality of life and has been poorly investigated in specific
populations. Our aim was to determine the prevalence of FMS in
Brazilian hemodialysis (HD) patients and to investigate its
effects on the quality of life. We investigated 311 patients on
HD who were submitted to physical examination towards the
classification of FMS. All subjects from FMS and control groups
were submitted to laboratorial investigation and completed
questionnaires of quality of life. The prevalence of FMS was
3.9%, which was close to that of the general population. Most
patients were females and from non-Caucasian races. No
difference between FMS and control groups was observed regarding
race, dialysis adequacy, nutritional status and level of
schooling. Ionized calcium was higher in the FMS group than in
the control group. There was no association between FMS and
secondary hyperparathyroidism. On the other hand, FMS was
associated with worse quality of life, depression and anxiety.
In conclusion, the prevalence of FMS in HD patients was similar
to that of the general population. It was associated with
decreasing quality of life in HD patients, in addition to higher
degrees of depression and anxiety. No laboratory tests could
identify FMS patients on HD. Fibromyalgia syndrome subsequently
follows without a well-established mechanism of pathogenesis,
and seems to be due to multifactorial causes. Its true impact on
the quality of life of HD patients deserves more attention by
nephrologists
(19) Jones KD, Burckhardt CS, Deodhar AA, Perrin NA,
Hanson GC, Bennett RM. A six-month randomized controlled trial
of exercise and pyridostigmine in the treatment of fibromyalgia.
Arthritis Rheum 2008; 58(2):612-22.
Abstract: OBJECTIVE: A subset of fibromyalgia (FM) patients have
a dysfunctional hypothalamic-pituitary-insulin-like growth
factor 1 (IGF-1) axis, as evidenced by low serum levels of IGF-1
and a reduced growth hormone (GH) response to physiologic
stimuli. There is evidence that pyridostigmine (PYD) improves
the acute response of GH to exercise in FM patients. The purpose
of this study was to evaluate the clinical effectiveness of 6
months of PYD and group exercise on FM symptoms. METHODS: FM
patients were randomized to 1 of the following 4 groups: PYD
plus exercise, PYD plus diet recall but no exercise, placebo
plus exercise, and placebo plus diet recall but no exercise. The
primary outcome measures were the visual analog scale (VAS)
score for pain, tender point count, and total myalgic score.
Secondary outcome measures were the total score on the
Fibromyalgia Impact Questionnaire (FIQ) and FIQ VAS scores for
individual symptoms (fatigue, poor sleep, stiffness, and
anxiety), as well as quality of life (QOL) and physical fitness
(lower body strength/endurance, upper and lower body
flexibility, balance, and time on the treadmill). RESULTS: A
total of 165 FM patients completed baseline measurements; 154
(93.3%) completed the study. The combination of PYD and exercise
did not improve pain scores. PYD groups showed a significant
improvement in sleep and anxiety in those who completed the
study and in QOL in those who complied with the therapeutic
regimen as compared with the placebo groups. Compared with the
nonexercise groups, the 2 exercise groups demonstrated
improvement in fatigue and fitness. PYD was generally well
tolerated. CONCLUSION: Neither the combination of PYD plus
supervised exercise nor either treatment alone yielded
improvement in most FM symptoms. However, PYD did improve
anxiety and sleep, and exercise improved fatigue and fitness. We
speculate that PYD may have improved vagal tone, thus benefiting
sleep and anxiety; this notion warrants further study
(20) Huber A, Suman AL, Biasi G, Carli G. Predictors of
psychological distress and well-being in women with chronic
musculoskeletal pain: two sides of the same coin? J Psychosom
Res 2008; 64(2):169-75.
Abstract: OBJECTIVE: To date, few results on well-being in
chronic-pain patients have been published, while several studies
in patients without pain have indicated that well-being may not
be equivalent to absence of psychological distress. The aim of
the present study was to investigate the relationship between
psychological distress and well-being and to identify the
predictors of each in patients with chronic nonmalignant pain.
METHODS: Sixty-nine women with chronic multiregional
musculoskeletal pain, 41 of whom met American College of
Rheumatology criteria for fibromyalgia, completed questionnaires
on pain, fatigue, stiffness, physical disability (Fibromyalgia
Impact Questionnaire), psychological distress [Multidimensional
Affect and Pain Survey (MAPS), Symptom Check List-90 (SCL-90),
State-Trait Anxiety Inventory Form Y2 (STAI-Y2)], and hedonic
and eudaimonic well-being (MAPS). RESULTS: Patients reported
increased amounts of psychological distress (STAI-Y2 and SCL-90)
compared to healthy people. Multiple regression analysis of
patient data demonstrated that higher psychological distress was
related to higher age, more intense pain, a higher positive
tender point count, and more physical disability. Well-being
(both hedonic and eudaimonic aspects) decreased with higher
disability, but was independent of age, pain intensity, and
number of positive tender points. Bivariate correlations showed
that psychological distress was moderately related to eudaimonic
well-being and strongly related to positive affect, an aspect of
hedonic well-being. CONCLUSION: In patients with chronic
musculoskeletal pain, self-reports of well-being and low
psychological distress only partially overlap with each other
and are differently related to major patient symptoms,
supporting the relevance of the concept of well-being to
chronic-pain research and a need for further studies in this
field
(21) Verbunt JA, Pernot DH, Smeets RJ. Disability and
quality of life in patients with fibromyalgia. Health Qual Life
Outcomes 2008; 6:8.:8.
Abstract: BACKGROUND: Patients with fibromyalgia often feel
disabled in the performance of daily activities. Psychological
factors seem to play a pronounced disabling role in
fibromyalgia.The objectives of the study are: Firstly, to
investigate contributing factors for disability in fibromyalgia.
Secondly, to study psychological distress in patients with
fibromyalgia as compared to other nonspecific pain syndromes.
And finally, to explore the impact of fibromyalgia on a
patient's quality of life. METHODS: In this cross sectional
study, explaining factors for disability were studied based on a
regression analysis with gender, mental health, physical and
social functioning as independent variables. For the assessment
of disability in fibromyalgia the FIQ was used. The levels of
psychological distress in patients with fibromyalgia, Complex
Regional Pain Syndrome (CRPS) and chronic low back pain (CLBP)
were compared based on scores on the Symptom Checklist (SCL90).
Quality of life of patients with fibromyalgia was compared with
scores (SF36) of both patients with fibromyalgia and other
health conditions as derived from the literature. RESULTS:
Disability in fibromyalgia seemed best explained by a patients
mental health condition (beta = -0.360 p = 0.02). The level of
psychological distress was higher in patients with fibromyalgia
as compared to patients with CRPS or CLBP (p < 0.01). The impact
of fibromyalgia on quality of life appeared to be high as
compared to the impact of other health conditions. CONCLUSION:
Patients with fibromyalgia report a considerable impact on their
quality of life and their perceived disability level seems
influenced by their mental health condition. In comparison with
patients with other pain conditions psychological distress is
higher
(22) Sarzi-Puttini P, Atzeni F, Di FM, Lama N,
Batticciotto A, Iannuccelli C et al. Anti-polymer antibodies are
correlated with pain and fatigue severity in patients with
fibromyalgia syndrome. Autoimmunity 2008; 41(1):74-9.
Abstract: OBJECTIVE: To investigate the prevalence of
antipolymer antibody (APA) in patients with fibromyalgia (FM)
and to examine its association with FM severity symptoms.
METHODS: The study population consisted of 79 FM patients and 75
controls: 32 with psoriatic arthritis and 43 with rheumatoid
arthritis APA levels were indirectly assayed using a commercial
ELISA kit from Corgenix (Westmister, Colorado, USA). Optical
density (OD) values were recorded on duplicates of each of the
reference and patient samples. Among clinical variables we
investigated pain, measured according to visual analog scales
(VAS: 0-100), fatigue, stiffness, anxiety, depression, all
measured by VAS (0-100), and health status measured by
Fibromyalgia Impact Questionnaire (FIQ). RESULTS: Sixteen of the
79 FM patients (20.3%) and 12/78 controls (15.4%) were positive
for APAs (P = 0.536). Following ROC analysis, area under curve (AUC)
was 0.49 (95% CI: 0.40, 0.58). Focusing on FM patients, we
observed a correlation between APA titre and pain (tau: - 0.221;
P = 0.020) and fatigue (tau: - 0.205; P = 0.032) at univariate
analysis. Binomial regression analysis, controlling for clinical
and demographic variables, showed that pain (PPR: 0.923; P =
0.007) and fatigue (PPR: 0.948; P = 0.024) were significantly
associated with APA test sensitivity. CONCLUSIONS: APA test
exhibited a low sensitivity in FM patients and it did not
distinguish this group of patients from the controls enrolled in
this study. Interestingly, positive APA test prevalence
increased with less severe pain or fatigue
(23) Naring GW, van LW, Geenen R. Somatoform
dissociation and traumatic experiences in patients with
rheumatoid arthritis and fibromyalgia. Clin Exp Rheumatol 2007;
25(6):872-7.
Abstract: OBJECTIVE: Trauma and dissociation tend to be
interrelated. The objective of this study was to examine the
frequency of traumatic experiences and somatoform dissociation
in patients with fibromyalgia syndrome (FMS) or rheumatoid
arthritis (RA), two conditions that are both characterized by
pain and disability. METHODS: Patients with a diagnosis of FMS
(2 male, 26 female; mean age 42 +/- 11 years) or RA (5 male, 46
female; mean age 46 +/- 10 years) completed the Fibromyalgia
Impact Questionnaire (FIQ), the Somatoform Dissociation
Questionnaire (SDQ), and the Traumatic Experience Checklist
(TEC). RESULTS: Patients with FMS reported significantly higher
levels of various forms of traumatization and dissociation than
patients with RA. In patients with FMS, but not in patients with
RA, there was a significant correlation between traumatization
and dissociative symptoms. A possible dissociative disorder was
indicated in 10% of the patients with FMS and 2% of the patients
with RA. CONCLUSION: Traumatization experiences are frequent in
FMS, but as compared to conversion disorder or dissociative
identity disorder only a small subgroup of patients with FMS or
RA shows the combination of traumatization and somatoform
dissociation. The observation of somatoform dissociation calls
for a broad treatment approach with a special role of the
psychologist or psychiatrist
(24) Munguia-Izquierdo D, Legaz-Arrese A. Exercise in
warm water decreases pain and improves cognitive function in
middle-aged women with fibromyalgia. Clin Exp Rheumatol 2007;
25(6):823-30.
Abstract: OBJECTIVES: To compare the cognitive function
performance in patients with fibromyalgia (FM) with respect
healthy controls and to evaluate the short-term efficacy of
exercise therapy in a warm, chest-high pool on pain and
cognitive function in women with FM. METHODS: Sixty middle-aged
women with FM were randomly assigned to either an exercise
training group (n = 35) to perform 3 sessions per week of
aquatic training (32 degrees C) including mobility, aerobic,
strengthening, and relaxation exercises for 16 weeks, or a
control group (n = 25). Twenty-five healthy women matched for
age, weight, body mass index, and educational and physical
activity levels were recruited. Pain was assessed in patients
using a syringe calibrated like a pressure dolorimeter, and a
visual analog scale. The severity of FM was evaluated using the
Fibromyalgia Impact Questionnaire. Cognitive function was
measured in healthy individuals and patients using several
standardized neuropsychological tests. All patients were
measured at baseline and post-treatment. RESULTS: At baseline,
the healthy group evidenced cognitive performance that was
significantly superior to the group of patients with FM in all
of the neuropsychological tests. The exercise group
significantly improved their pain threshold, tender point count,
self-reported pain, severity of FM, and cognitive function,
while in the control group the differences were not significant.
CONCLUSION: An exercise therapy three times per week for 16
weeks in a warm-water pool is an adequate treatment to decrease
the pain and severity of FM well as to improve cognitive
function in previously unfit women with FM and heightened
painful symptomatology
(25) da Silva GD, Lorenzi-Filho G, Lage LV. Effects of
yoga and the addition of Tui Na in patients with fibromyalgia. J
Altern Complement Med 2007; 13(10):1107-13.
Abstract: OBJECTIVES: This study aimed to verify whether
techniques of yoga with and without the addition of Tui Na might
improve pain and the negative impact of fibromyalgia (FMS) on
patients' daily life. DESIGN: Forty (40) FMS women were
randomized into two groups, Relaxing Yoga (RY) and Relaxing Yoga
plus Touch (RYT), for eight weekly sessions of stretching,
breathing, and relaxing yogic techniques. RYT patients were
further submitted to manipulative techniques of Tui Na. OUTCOME
MEASURE: Outcome measures comprised the Fibromyalgia Impact
Questionnaire (FIQ), pain threshold at the 18 FMS tender points,
and a verbal graduation of pain assessed before treatment and on
the followup. The visual analog scale (VAS) for pain was
assessed before and after each session and on the follow-up.
RESULTS: Seventeen (17) RYT and 16 RY patients completed the
study. Both RY and RYT groups showed improvement in the FIQ and
VAS scores, which decreased on all sessions. The RYT group
showed lower VAS and verbal scores for pain on the eighth
session, but this difference was not maintained on the
follow-up. Conversely, RY VAS and verbal scores were
significantly lower just on the follow-up. CONCLUSIONS: These
study results showed that yogic techniques are valid therapeutic
methods for FMS. Touch addition yielded greater improvement
during the treatment. Over time, however, RY patients reported
less pain than RYT. These results suggest that a passive therapy
may possibly decrease control over FMS symptoms
(26) Duncan B, White A, Rahman A. Acupuncture in the
treatment of fibromyalgia in tertiary care--a case series.
Acupunct Med 2007; 25(4):137-47.
Abstract: AIMS: Fibromyalgia is a common cause of chronic
widespread pain. The benefit of medication is often limited by
its side effects, and the improvements obtained with exercise
and education are inconsistent. Many patients seek acupuncture
treatment, which is reported to be helpful in some cases. This
study aimed to explore the acceptability and benefits of
acupuncture offered in the setting of a tertiary referral
clinic. METHODS: An open, uncontrolled observational study was
conducted among patients who met the usual fibromyalgia criteria
and who had a pain score of at least 30 on a 100mm Visual
Analogue Scale (VAS). Patients were allowed to continue other
treatments but not to introduce new ones. Acupuncture was given
using a Western approach according to a protocol developed by
consensus. Patients were offered eight treatments in eight
weeks. Outcome measures included VAS of pain intensity and
Fibromyalgia Impact Questionnaire (range 0 - 100), and were
taken before and after treatment, and at 14, 20 and 34 weeks
from enrolment. RESULTS: Twenty four eligible patients were
enrolled in a 12 month period. Baseline mean pain VAS score for
these 24 patients was 74 (SD 18) and mean Fibromyalgia Impact
Questionnaire score 78 (SD 12.4). Only 14 patients completed the
course of treatment within about 10 weeks. Compliance was poor
in the remaining patients because of difficulty attending
clinic, and in two cases because of exacerbation of pain.
Completion of outcome measures was variable and therefore the
analysis of data is limited. Five patients scored at least 20%
reduction in Fibromyalgia Impact Questionnaire score which is a
clinically relevant improvement. Two of these scored at least
50% reduction. CONCLUSION: Acupuncture appears to offer
symptomatic improvement to some patients with fibromyalgia in a
tertiary clinic who have failed to respond to other treatments.
In view of its safety, further acupuncture research is justified
in this population
(27) Nieddu ME, Menza L, Baldi F, Frediani B, Marcolongo
R. [Efficacy of Cellfood(R)'s therapy (deutrosulfazyme) in
fibromyalgia.]. Reumatismo 2007; 59(4):316-21.
Abstract: OBJECTIVE: To assess the efficacy of Cellfood(R)'s
therapy in the treatment of fibromyalgia. METHODS: This study
was a single-blind, cross-over, randomized placebo-controlled
trial. Forty female were selected from 320 cases investigated in
the period 2003-2005 of June. To be included in this study, it
was required that the diagnosis of fibromyalgia was made by a
specialist in according to the ACR classification criteria of
1990. The patient's age was between 35-47 years, the choice of
criteria were the absence of improvements with the conventional
therapy and the normality of medical check-up. The patients were
divided into two different-groups of thirty-one and nine
subjects, each-one (group A) treated with Cellfood(R) for six
months in according to the Eurodream's scheme, and each-other
(group B) treated with placebo for three months and successively
with Cellfood(R) for three months. Besides we have estimated the
tender points with algometer and the health status of women with
the Fibromyalgia Impact Questionnaire (FIQ) at the baseline (T0)
and at three (T1) and six month (T2). RESULT: The group A had an
appreciable improvement of the parameters at T1 statistically
significant compared to the group B, while we observed a
stability of they at T2 on the group A and an improvement of the
parameters of the group B statistically non significant compared
to each-one. CONCLUSION: Our result suggest that the
Cellfood(R)'s therapy improve fibromyalgia symptoms and
health-related quality of life
(28) Ribel-Madsen S, Christgau S, Gronemann ST, Bartels
EM, nneskiold-Samsoe B, Bliddal H. Urinary markers of altered
collagen metabolism in fibromyalgia patients. Scand J Rheumatol
2007; 36(6):470-7.
Abstract: OBJECTIVE: To assess the metabolism of collagen in
fibromyalgia (FM) patients, and to compare the occurrence of
collagen metabolism markers to the severity of FM symptoms.
METHODS: Morning urine was collected from 27 FM women fulfilling
the American College of Rheumatology (ACR) criteria for FM, and
from seven controls. FM patients completed the Fibromyalgia
Impact Questionnaire (FIQ). Bone mineral density (BMD),
isokinetic muscle strength in knee and elbow, and hand-grip
strength were measured. Urinary concentrations of collagen type
I cross-linked C-telopeptide (CTX-I) and collagen type II
cross-linked C-telopeptide (CTX-II) were determined by
enzyme-linked immunosorbent assay (ELISA). Pyridinoline (Pyd)
and deoxypyridinoline (Dpd) were determined by liquid
chromatography, and hydroxyproline (Hyp) by spectrophotometry.
All concentration data were normalized to creatinine. RESULTS:
Mean values in the FM group and the control group, respectively,
were: urinary CTX-I 246.8 and 337.5 microg/mmol (p = 0.060); CTX-II
110.4 and 185.1 ng/mmol (p = 0.035); Pyd 56.1 and 52.3 nmol/mmol
(NS); Dpd 15.1 and 14.0 nmol/mmol (NS); Pyd : Dpd ratio 4.05 and
3.96 (NS); Hyp 26.1 and 21.1 micromol/mmol (NS). Significant
inverse correlations were seen between CTX-I and the intensity
of fatigue, and between CTX-II and anxiety. An inverse
correlation between CTX-I and muscle strength was apparent, but
relied on extreme values from one patient, and no significant
correlation was found between CTX-I or CTX-II and tender points
or BMD in the FM group. CONCLUSIONS: Low urinary concentrations
of CTX-II and CTX-I and normal levels of Pyd and Dpd were found
in FM, but their relationship to the intensity of FM symptoms
was unclear
(29) Cuatrecasas G, Riudavets C, Guell MA, Nadal A.
Growth hormone as concomitant treatment in severe fibromyalgia
associated with low IGF-1 serum levels. A pilot study. BMC
Musculoskelet Disord 2007; 8:119.:119.
Abstract: BACKGROUND: There is evidence of functional growth
hormone (GH) deficiency, expressed by means of low insulin-like
growth factor 1 (IGF-1) serum levels, in a subset of
fibromyalgia patients. The efficacy of GH versus placebo has
been previously suggested in this population. We investigated
the efficacy and safety of low dose GH as an adjunct to standard
therapy in the treatment of severe, prolonged and well-treated
fibromyalgia patients with low IGF-1 levels. METHODS:
Twenty-four patients were enrolled in a randomized, open-label,
best available care-controlled study. Patients were randomly
assigned to receive either 0.0125 mg/kg/d of GH subcutaneously
(titrated depending on IGF-1) added to standard therapy or
standard therapy alone during one year. The number of tender
points, the Fibromyalgia Impact Questionnaire (FIQ) and the
EuroQol 5D (EQ-5D), including a Quality of Life visual analogic
scale (EQ-VAS) were assessed at different time-points. RESULTS:
At the end of the study, the GH group showed a 60% reduction in
the mean number of tender points (pairs) compared to the control
group (p < 0.05; 3.25 +/- 0.8 vs. 8.25 +/- 0.9). Similar
improvements were observed in FIQ score (p < 0.05) and EQ-VAS
scale (p < 0.001). There was a prompt response to GH
administration, with most patients showing improvement within
the first months in most of the outcomes. The concomitant
administration of GH and standard therapy was well tolerated,
and no patients discontinued the study due to adverse events.
CONCLUSION: The present findings indicate the advantage of
adding a daily GH dose to the standard therapy in a subset of
severe fibromyalgia patients with low IGF-1 serum levels. TRIAL
REGISTRATION: NCT00497562 (ClinicalTrials.gov)
(30) Ayan C, Martin V, onso-Cortes B, Alvarez MJ,
Valencia M, Barrientos MJ. Relationship between aerobic fitness
and quality of life in female fibromyalgia patients. Clin
Rehabil 2007; 21(12):1109-13.
Abstract: OBJECTIVE: To determine whether there is a direct link
between quality of life and aerobic capacity among female
fibromyalgia patients. DESIGN: Cross-section study. SETTING:
University of Leon.Subjects: Twenty-nine women belonging to the
Leon Fibromyalgia and Chronic Fatigue Association. MAIN
MEASUREMENTS: Aerobic capacity and quality of life were measured
by means of the Six-Minute Walk Test and the Fibromyalgia Impact
Questionnaire. Outcome measures included heart rate and rate of
perceived fatigue and dypsnoea. RESULTS: The average distance
walked was 432.8 (61.2) m and the total average Fibromyalgia
Impact Questionnaire score was 47.5 (18.9). Only item 1 of the
Fibromyalgia Impact Questionnaire, physical function, showed any
statistically significant link with the distance walked, which
had no statistically significant relationship with any of the
variables studied. CONCLUSION: The physical fitness of women
with fibromyalgia, as determined by the Six-Minute Walk Test and
the Fibromyalgia Impact Questionnaire, has no direct relation
with quality of life as the patients perceive it
(31) Walitt B, Roebuck-Spencer T, Bleiberg J, Foster G,
Weinstein A. Automated neuropsychiatric measurements of
information processing in fibromyalgia. Rheumatol Int 2008;
28(6):561-6.
Abstract: Aberrant central neurological functioning is believed
to contribute to the abnormal sensations of fibromyalgia (FM).
Most patients with FM complain of diminished cognitive function.
This study sought to compare objective cognitive function
between FM and healthy controls at baseline and to determine if
symptomatic improvement was related to objective cognitive
improvement. Automated neuropsychological assessment metrics (ANAM)
was used to quantify neurocognitive function. Performance on
ANAM was compared between subjects with FM, musculoskeletal
pain, and pain-free controls. Ten separate FM subjects completed
an 8-week comprehensive treatment program. Serial testing with
ANAM and the Fibromyalgia Impact Questionnaire was conducted.
Statistical analysis was performed using repeated Wilcoxon
signed rank tests. No differences were noted on ANAM between
controls and subjects with pain disorders. A clinical
improvement (FIQ median change 33.9, P = 0.002) was noted with
treatment without concomitant change in ANAM scores. No
cognitive impairment in FM was demonstrated using ANAM
(32) Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma
U. The effect of anxiety and depression on improvements in pain
in a randomized, controlled trial of pregabalin for treatment of
fibromyalgia. Pain Med 2007; 8(8):633-8.
Abstract: OBJECTIVE: To assess symptoms of anxiety and
depression in a large cohort of fibromyalgia patients and to
determine the impact of these symptoms on response of pain to
pregabalin treatment. DESIGN: Patients completed the Hospital
Anxiety and Depression Scale at the baseline visit in a
randomized, controlled trial of pregabalin for treatment of
fibromyalgia. Mean anxiety and depression subscale scores were
calculated, and proportions of patients by symptom severity were
determined. The difference between the proportion of patients
reporting anxiety and depression at baseline was tested using
McNemar's test. Baseline anxiety and depression were evaluated
as covariates by including them-as interaction terms with
treatment-in an ancova model. A path analysis evaluated the
association between improvements in anxiety and depression and
pain relief. RESULTS: In total, 529 patients were enrolled.
Significantly more patients reported anxiety symptoms (71%) than
depressive symptoms (56%) (P < 0.0001). Improvement in pain
symptoms with pregabalin compared with placebo did not depend
linearly on baseline anxiety or depression scores. By path
analysis, 75% of the pain reduction was not explained by
improvements in anxiety and depressive symptoms. CONCLUSIONS:
Anxiety symptoms were more common than depressive symptoms in
this cohort. Our results suggest patients with fibromyalgia
should be routinely assessed for the presence of both anxiety
and depression. The pain treatment effect of pregabalin did not
depend on baseline anxiety or depressive symptoms, suggesting
pregabalin improves pain in patients with or without these
symptoms. Much of the pain reduction appears to be independent
of improvements in anxiety or mood symptoms
(33) Rooks DS, Gautam S, Romeling M, Cross ML,
Stratigakis D, Evans B et al. Group exercise, education, and
combination self-management in women with fibromyalgia: a
randomized trial. Arch Intern Med 2007; 167(20):2192-200.
Abstract: BACKGROUND: Self-management has increasingly been
recommended as part of standard care for fibromyalgia, a common,
poorly understood condition with limited treatment options. Data
that assess popular self-management recommendations are scarce.
We evaluated and compared the effectiveness of 4 common
self-management treatments on function, symptoms, and
self-efficacy in women with fibromyalgia. METHODS: A total of
207 women with confirmed fibromyalgia were recruited from
September 16, 2002, through November 30, 2004, and randomly
assigned to 16 weeks of (1) aerobic and flexibility exercise
(AE); (2) strength training, aerobic, and flexibility exercise
(ST); (3) the Fibromyalgia Self-Help Course (FSHC); or (4) a
combination of ST and FSHC (ST-FSHC). The primary outcome was
change in physical function from baseline to completion of the
intervention. Secondary outcomes included social and emotional
function, symptoms, and self-efficacy. RESULTS: Improvements in
the mean Fibromyalgia Impact Questionnaire score in the 4 groups
were -12.7 for the ST-FSHC group, -8.2 for the AE group, -6.6
for the ST group, and -0.3 for the FSHC group. The ST-FSHC group
demonstrated greater improvement than the FSHC group (mean
difference, -12.4; 95% confidence interval [CI], -23.1 to -1.7).
The ST-FSHC (mean difference, 13.6; 95% CI, 2.3 to 24.9) and AE
(mean difference, 13.1; 95% CI, 1.6 to 25.6) groups had similar
improvements in physical function scores on the 36-Item
Short-Form Health Survey. Bodily pain scores on the 36-Item
Short-Form Health Survey improved in the ST-FSHC (14.8), AE
(13.2), and ST (5.7) groups. Social function, mental health,
fatigue, depression, and self-efficacy also improved. The
beneficial effect on physical function of exercise alone and in
combination with education persisted at 6 months. CONCLUSIONS:
Progressive walking, simple strength training movements, and
stretching activities improve functional status, key symptoms,
and self-efficacy in women with fibromyalgia actively being
treated with medication. The benefits of exercise are enhanced
when combined with targeted self-management education. Our
findings suggest that appropriate exercise and patient education
be included in the treatment of fibromyalgia
(34) Roizenblatt S, Fregni F, Gimenez R, Wetzel T,
Rigonatti SP, Tufik S et al. Site-specific effects of
transcranial direct current stimulation on sleep and pain in
fibromyalgia: a randomized, sham-controlled study. Pain Pract
2007; 7(4):297-306.
Abstract: OBJECTIVE: To investigate whether active anodal
transcranial direct current stimulation (tDCS) (of dorsolateral
prefrontal cortex [DLPFC] and primary motor cortex [M1]) as
compared to sham treatment is associated with changes in sleep
structure in fibromyalgia. METHODS: Thirty-two patients were
randomized to receive sham stimulation or active tDCS with the
anode centered over M1 or DLPFC (2 mA, 20 minutes for five
consecutive days). A blinded evaluator rated the clinical
symptoms of fibromyalgia. All-night polysomnography was
performed before and after five consecutive sessions of tDCS.
RESULTS: Anodal tDCS had an effect on sleep and pain that was
specific to the site of stimulation: such as that M1 and DLPFC
treatments induced opposite effects on sleep and pain, whereas
sham stimulation induced no significant sleep or pain changes.
Specifically, whereas M1 treatment increased sleep efficiency
(by 11.8%, P = 0.004) and decreased arousals (by 35.0%, P =
0.001), DLPFC stimulation was associated with a decrease in
sleep efficiency (by 7.5%, P = 0.02), an increase in rapid eye
movement (REM) and sleep latency (by 47.7%, P = 0.0002, and
133.4%, P = 0.02, respectively). In addition, a decrease in REM
latency and increase in sleep efficiency were associated with an
improvement in fibromyalgia symptoms (as indexed by the
Fibromyalgia Impact Questionnaire). Finally, patients with
higher body mass index had the worse sleep outcome as indexed by
sleep efficiency changes after M1 stimulation. INTERPRETATION:
Our findings suggest that one possible mechanism to explain the
therapeutic effects of tDCS in fibromyalgia is via sleep
modulation that is specific to modulation of primary M1 activity
(35) Peleg R, Ablin JN, Peleg A, Neumann L, Rabia RA,
Buskila D. Characteristics of fibromyalgia in Muslim Bedouin
women in a primary care clinic. Semin Arthritis Rheum 2008;
37(6):398-402.
Abstract: BACKGROUND: Fibromyalgia (FM) has been described and
studied in various sociocultural settings in both developed and
developing countries. OBJECTIVES: To study the clinical
manifestations of FM and to describe its effect on quality of
life in the unique setting of Muslim Bedouin women in the
southern Israel Negev desert area. METHODS: One hundred two
Bedouin women were recruited from a primary health care clinic
in the Negev area. All patients fulfilled American College of
Rheumatology criteria for the diagnosis of FM. Tenderness was
assessed by manual dolorimetry and the fibromyalgia impact
questionnaire was utilized to estimate the severity of FM
symptoms. Anxiety and depression were assessed by the Arthritis
Impact Measurement Scales subscales and quality of life was
evaluated by the SF-36 questionnaire. RESULTS: The study
population was characterized by a low educational level, a high
rate of consanguinity, a high number of children per mother, and
a high rate of polygamy. There was a high frequency of classic
FM symptoms such as pain and fatigue, as well as anxiety and
depression. The overall impact of FM on quality of life was
exceedingly high (8.9 on a scale of 0 to 10). CONCLUSIONS: FM is
relatively common in the unique setting of Muslim Bedouin women
and has a very significant impact on their quality of life as
well as on their dependents. Physicians involved in the primary
care of this population should be attentive to the
manifestations of FM and related disorders
(36) Skrabek RQ, Galimova L, Ethans K, Perry D. Nabilone
for the treatment of pain in fibromyalgia. J Pain 2008;
9(2):164-73.
Abstract: A randomized, double-blind, placebo-controlled trial
was conducted to determine the benefit of nabilone in pain
management and quality of life improvement in 40 patients with
fibromyalgia. After a baseline assessment, subjects were
titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID
over 4 weeks or received a corresponding placebo. At the 2- and
4-week visits, the primary outcome measure, visual analog scale
(VAS) for pain, and the secondary outcome measures, number of
tender points, the average tender point pain threshold, and the
Fibromyalgia Impact Questionnaire (FIQ), were evaluated. After a
4-week washout period, subjects returned for reassessment of the
outcome measures. There were no significant differences in
population demographics between groups at baseline. There were
significant decreases in the VAS (-2.04, P < .02), FIQ (-12.07,
P < .02), and anxiety (-1.67, P < .02) in the nabilone treated
group at 4 weeks. There were no significant improvements in the
placebo group. The treatment group experienced more side effects
per person at 2 and 4 weeks (1.58, P < .02 and 1.54, P < .05),
respectively. Nabilone appears to be a beneficial,
well-tolerated treatment option for fibromyalgia patients, with
significant benefits in pain relief and functional improvement.
PERSPECTIVE: To our knowledge, this is the first randomized,
controlled trial to assess the benefit of nabilone, a synthetic
cannabinoid, on pain reduction and quality of life improvement
in patients with fibromyalgia. As nabilone improved symptoms and
was well-tolerated, it may be a useful adjunct for pain
management in fibromyalgia
(37) Vargas-Alarcon G, Fragoso JM, Cruz-Robles D, Vargas
A, Vargas A, Lao-Villadoniga JI et al.
Catechol-O-methyltransferase gene haplotypes in Mexican and
Spanish patients with fibromyalgia. Arthritis Res Ther 2007;
9(5):R110.
Abstract: Autonomic dysfunction is frequent in patients with
fibromyalgia (FM). Heart rate variability analyses have
demonstrated signs of ongoing sympathetic hyperactivity.
Catecholamines are sympathetic neurotransmitters.
Catechol-O-methyltransferase (COMT), an enzyme, is the major
catecholamine-clearing pathway. There are several
single-nucleotide polymorphisms (SNPs) in the COMT gene
associated with the different catecholamine-clearing abilities
of the COMT enzyme. These SNPs are in linkage disequilibrium and
segregate as 'haplotypes'. Healthy females with a particular
COMT gene haplotype (ACCG) producing a defective enzyme are more
sensitive to painful stimuli. The objective of our study was to
define whether women with FM, from two different countries
(Mexico and Spain), have the COMT gene haplotypes that have been
previously associated with greater sensitivity to pain. All the
individuals in the study were female. Fifty-seven Mexican
patients and 78 Spanish patients were compared with their
respective healthy control groups. All participants filled out
the Fibromyalgia Impact Questionnaire (FIQ). Six COMT SNPs
(rs2097903, rs6269, rs4633, rs4818, rs4680, and rs165599) were
genotyped from peripheral blood DNA. In Spanish patients, there
was a significant association between three SNPs (rs6269,
rs4818, and rs4680) and the presence of FM when compared with
healthy controls. Moreover, in Spanish patients with the 'high
pain sensitivity' haplotype (ACCG), the disease, as assessed by
the FIQ, was more severe. By contrast, Mexican patients
displayed only a weak association between rs6269 and rs165599,
and some FIQ subscales. In our group of Spanish patients, there
was an association between FM and the COMT haplotype previously
associated with high pain sensitivity. This association was not
observed in Mexican patients. Studies with a larger sample size
are needed in order to verify or amend these preliminary results
(38) varez-Nemegyei J, Negreros-Castillo A,
Nuno-Gutierrez BL, varez-Berzunza J, cocer-Martinez LM.
[Ericksonian hypnosis in women with fibromyalgia syndrome]. Rev
Med Inst Mex Seguro Soc 2007; 45(4):395-401.
Abstract: BACKGROUND: Fibromyalgia syndrome (FS) is a chronic,
painful, generalized musculoskeletal disorder in which some
efficacy for the conventional hypnosis modality has been
claimed. Objective: to assess the efficacy of the Ericksonian
modality hypnosis in FS management. MATERIAL AND METHODS:
Forty-three FS female patients (44 +/- 4.7 years old) were
included. They were randomized to receive for six months:
Ericksonian hypnosis (EH; 20 subjects) or a sham-hypnosis (SH;
23 subjects). Every month, patient and physician global disease
assessment, tender point count and the Fibromyalgia Impact
Questionnaire (FIQ) were measured. RESULTS: During the
follow-up, we did not find inter-group differences for the rate
of change related to the baseline values for the patient and
physician global disease assessment and the FIQ scores. At the
third month (4.0 +/- 4.6 vs. 0.6 +/- 3.1; p = 0.02), and at the
fourth month (5.0 +/- 4.6 vs. 0.8 +/- 4.0; p = 0.03) of
follow-up, the participants who received EH had a significant
reduction of the tender point count after adjustment for
patient's age. CONCLUSIONS: Despite no effect was noted on the
functional status and the patient and physician global
assessment, EH produced a reduction in the number of tender
points in FS. Thus, HE may be an adjuvant treatment for the
management of FS patients
(39) Arnold LM, Pritchett YL, D'Souza DN, Kajdasz DK,
Iyengar S, Wernicke JF. Duloxetine for the treatment of
fibromyalgia in women: pooled results from two randomized,
placebo-controlled clinical trials. J Womens Health (Larchmt )
2007; 16(8):1145-56.
Abstract: BACKGROUND: To assess the efficacy (in particular, in
pain, functional impairment, and quality of life) and safety and
tolerability (incidence of adverse events, discontinuation
rates, changes in laboratory findings, and vital signs) of
duloxetine in female patients with fibromyalgia. METHODS: Data
were pooled from two placebo-controlled clinical trials of
similar design (randomized, 12-week, and double-blind),
comparing duloxetine 60 mg a day (q.d.) or 60 mg twice daily
(b.i.d.) (n = 326) with placebo (n = 212), in women who met the
American College of Rheumatology criteria for primary
fibromyalgia. RESULTS: Compared with the patients receiving
placebo, duloxetine-treated female patients demonstrated a
significantly greater improvement in the Brief Pain Inventory
(BPI) average pain severity score and in the Fibromyalgia Impact
Questionnaire (FIQ) total score, beginning at week 1 and
continuing through week 12 (p < 0.001). Duloxetine was superior
to placebo on all efficacy measures, including mean tender point
threshold, Clinical Global Impression of Severity, Patient
Global Impression of Improvement, and average interference from
pain scores. The duloxetine-treated group was superior to
placebo on all quality of life and functional measures,
including each domain of the Medical Outcomes Study Short
Form-36 (SF-36). A direct treatment effect of duloxetine on pain
reduction was demonstrated and shown to be independent of
secondary improvement in mood (based on BPI average pain score).
Significantly more duloxetine-treated patients reported
treatment-emergent adverse events (296 [90.8%]
duloxetine-treated and 165 [77.8%] placebo-treated, p < 0.001).
Rates of serious adverse events were similar between
duloxetine-treated and placebo-treated patients. CONCLUSIONS:
The pooled results of these studies demonstrate that duloxetine
is a safe and efficacious treatment for both the pain and
functional impairment associated with fibromyalgia in female
patients, while significantly improving quality of life
(40) Ubago Linares MC, Ruiz-Perez I, Bermejo Perez MJ,
Olry dL-L, Hernandez-Torres E, Plazaola-Castano J. Analysis of
the impact of fibromyalgia on quality of life: associated
factors. Clin Rheumatol 2008; 27(5):613-9.
Abstract: We analysed the impact of fibromyalgia (FM) on the
functional capacity of patients suffering this syndrome and
identified factors that are associated with greater disease
impact. We performed a cross-sectional descriptive telephone
survey on all patients diagnosed with fibromyalgia during 2003
in a university hospital in Spain. Variables studied were
socio-demographic, job, clinical, health and psycho-social
characteristics of patients diagnosed with FM and impact of FM
on them. Disease impact was measured by means of the
Fibromyalgia Impact Questionnaire (FIQ). The rest of variables
were collected by means of an expressly designed questionnaire.
The relation between FIQ score and the other variables was
performed with a bivariate analysis, using several tests
depending on the variables involved. To analyse the factors
associated with greatest disease impact, a multivariate linear
regression model was designed. The average FIQ score for the
sample was 63.6. Having a larger number of children, being tired
and being in a depressed mood were the symptoms that most
affected activities of daily living. A diagnosis of any mental
illness, reference to repercussion on the family environment, a
lower self-rated health and having consulted more specialists
before FM diagnosis were associated with a higher impact after
adjusting according to all the variables in the model. It can be
confirmed that the FIQ is a useful instrument for measuring the
impact of FM on quality of life. Identifying factors that
determine the extent of its impact will enable more effective
therapeutic strategies to be designed
(41) Gursoy S, Erdal E, Sezgin M, Barlas IO, Aydeniz A,
Alasehirli B et al. Which genotype of MAO gene that the patients
have are likely to be most susceptible to the symptoms of
fibromyalgia? Rheumatol Int 2008; 28(4):307-11.
Abstract: The objective of this study was to analyze the
genotype distributions and allele frequencies for the MAO-A and
MAO-B polymorphism of the MAO gene among the patients with
fibromyalgia syndrome (FS). One hundred and seven fibromyalgia
patients and 90 unrelated healthy subjects were included into
the study. Genomic DNA of 107 FS patients and 90 healthy control
subjects were analyzed by polymerase chain reaction.
Polymorphism of the MAO gene was: 1-1, 1-3, 3-3, 3-4. The
"allele 3" had a 2.7 to 4.8-fold increased transcription
activity than the "allele 1". The frequencies of the genotypes
of the patients with FS and healthy controls were compared.
Although no significant difference was found in genotypes of
patients and controls (P = 0.0559), it is likely that "allele 3"
could be a more riskful factor for FS than "allele 1" (P =
0.033). Fibromyalgia impact questionnaire was administered to FS
group as well as control group. One of our findings is that, the
patients whose genotype 3-3 may be mostly affected by the
symptoms of FS. In conclusion, it seems plausible to say that
MAOA-dependent metabolism of the biological amines may be partly
related to high-activated MAO-A, allele 3, in the occurrence of
FS among Turkish population
(42) Passard A, Attal N, Benadhira R, Brasseur L, Saba
G, Sichere P et al. Effects of unilateral repetitive
transcranial magnetic stimulation of the motor cortex on chronic
widespread pain in fibromyalgia. Brain 2007; 130(Pt 10):2661-70.
Abstract: Non-invasive unilateral repetitive transcranial
magnetic stimulation (rTMS) of the motor cortex induces
analgesic effects in focal chronic pain syndromes, probably by
modifying central pain modulatory systems. Neuroimaging studies
have shown bilateral activation of a large number of structures,
including some of those involved in pain processing, suggesting
that such stimulation may induce generalized analgesic effects.
The goal of this study was to assess the effects of unilateral
rTMS of the motor cortex on chronic widespread pain in patients
with fibromyalgia. Thirty patients with fibromyalgia syndrome
(age: 52.6 +/- 7.9) were randomly assigned, in a double-blind
fashion, to two groups, one receiving active rTMS (n = 15) and
the other sham stimulation (n = 15), applied to the left primary
motor cortex in 10 daily sessions. The primary outcome measure
was self-reported average pain intensity over the last 24 h,
measured at baseline, daily during the stimulation period and
then 15, 30 and 60 days after the first stimulation. Other
outcome measures included: sensory and affective pain scores for
the McGill pain Questionnaire, quality of life (assessed with
the pain interference items of the Brief Pain Inventory and the
Fibromyalgia Impact Questionnaire), mood and anxiety (assessed
with the Hamilton Depression Rating Scale, the Beck Depression
Inventory and the Hospital Anxiety and Depression Scale). We
also assessed the effects of rTMS on the pressure pain threshold
at tender points ipsi- and contralateral to stimulation.
Follow-up data were obtained for all the patients on days 15 and
30 and for 26 patients (13 in each treatment group) on day 60.
Active rTMS significantly reduced pain and improved several
aspects of quality of life (including fatigue, morning
tiredness, general activity, walking and sleep) for up to 2
weeks after treatment had ended. The analgesic effects were
observed from the fifth stimulation onwards and were not related
to changes in mood or anxiety. The effects of rTMS were more
long-lasting for affective than for sensory pain, suggesting
differential effects on brain structures involved in pain
perception. Only few minor and transient side effects were
reported during the stimulation period. Our data indicate that
unilateral rTMS of the motor cortex induces a long-lasting
decrease in chronic widespread pain and may therefore constitute
an effective alternative analgesic treatment for fibromyalgia
(43) Mannerkorpi K, Rivano-Fischer M, Ericsson A,
Nordeman L, Gard G. Experience of physical activity in patients
with fibromyalgia and chronic widespread pain. Disabil Rehabil
2008; 30(3):213-21.
Abstract: PURPOSE: Patients with fibromyalgia (FM) and chronic
widespread pain (CWP) find physical activity troublesome. The
purpose was to develop a questionnaire to investigate the
experience of physical activity in FM and CWP populations.
METHOD: A questionnaire was developed from a qualitative study.
After that, a total of 204 patients with FM or CWP completed the
questionnaire. A factor analysis was conducted and the internal
consistency was investigated. The relationship between the
factors and pain, health status (the Fibromyalgia Impact
Questionnaire, FIQ), distress (the Hospital Anxiety and Distress
scale, HAD) and leisure time physical activity (the Leisure Time
Physical Activity Instrument, LTPAI) was investigated. RESULTS:
Five factors were identified: Physical Relaxation (PR),
Well-being (WB), Activity Beliefs (AB), Activity-related
Symptoms (AS) and Activity Habits (AH). Cronbach's alpha ranged
from 0.57 to 0.86. The PR showed a correlation (rho 0.28, p <
0.01) with the FIQ Pain. The AS showed a correlation (rho 0.25,
p < 0.01) with the FIQ total score, while the AH showed a
correlation with the HAD Depression (0.26, p < 0.01) and with
strenuous physical activity (LTPAI) (-0.32, p < 0.01).
CONCLUSION: A new instrument was developed to study the
experience of physical activity in persons with long-lasting
pain. Five factors were identified using factor analysis, and
three of them showed fair associations with FM symptoms,
distress or physical activity
(44) Bazzichi L, Giacomelli C, De FF, Giuliano T, Rossi
A, Doveri M et al. Antipolymer antibody in Italian fibromyalgic
patients. Arthritis Res Ther 2007; 9(5):R86.
Abstract: The objectives of the present study were to evaluate
the presence of antipolymer antibody (APA) seropositivity in 285
Italian patients affected by primary fibromyalgia (FM) and to
verify whether APA levels correlate with disease severity and
with cytokine levels.APA levels were determined on serum samples
by an indirect ELISA kit that detects IgG APA. Cytokines (IL-1,
IL-6, IL-8, IL-10 and TNFalpha) were measured by ELISA in
plasma. The impact of FM on the quality of life was estimated
using the Fibromyalgia Impact Questionnaire, while pain severity
was evaluated using a visual analogic scale. Patients were also
characterized by the presence of tiredness, stiffness,
nonrestorative sleep, anxiety, depression, tension headache,
irritable bowel syndrome, temporomandibular dysfunction and
Raynaud's phenomena. Using a cut-off value of 30 U, APA-positive
values were detected in 60 FM patients (21.05%) and in 15
healthy control individuals (15.00%) without significant
differences among their levels or the percentage of
seropositivity. FM patients with moderate and severe symptoms
had slightly higher APA levels with respect to patients with
mild symptoms. APA-seropositive patients exhibited significant
correlations between APA levels and the Fibromyalgia Impact
Questionnaire estimate (P = 0.042), tiredness (P = 0.003) and
IL-1 levels (P = 0.0072). In conclusion, APA cannot be
considered a marker of disease in Italian FM patients. The
presence of APA, however, might permit the identification of a
subset of FM patients with more severe symptoms and of patients
who may respond differently to different therapeutic strategies
(45) Al-Allaf AW. Work disability and health system
utilization in patients with fibromyalgia syndrome. J Clin
Rheumatol 2007; 13(4):199-201.
Abstract: BACKGROUND: Fibromyalgia syndrome (FMS) usually
affects women of working age. We expect significant work-related
disability in association with FMS. Because of the variety of
symptoms, these patients often have multiple visits to their
general practitioners with many referrals and visits to various
specialists. OBJECTIVE: To investigate the impact of
fibromyalgia on working disability and health system
utilization. METHOD: This was a case-control study comparing
fibromyalgia outpatient attendees with controls attending
nonrheumatology outpatient clinics in Eastern Scotland. One
hundred thirty-six patients with FMS and 152 age- and
sex-matched controls completed a postal questionnaire about
their working history and attendance at various outpatient
clinics and general practitioners' visits. RESULTS: Significant
number of patients with FMS (46.8%) reported that they lost
their job because of the disease, compared with only 14.1% of
controls (P < 0.00001). There was no significant difference in
health system utilization between patients with FMS and other
clinic controls in a subset of patients surveyed. CONCLUSION:
Fibromyalgia is significantly associated with reports of working
disability. Reasons for this decreased employment need to be
investigated. The impact on the health system appeared to be the
same as for patients with known specific organic diseases with
regard to the number of general practitioner or hospital visits
(46) Tander B, Atmaca A, Aliyazicioglu Y, Canturk F.
Serum ghrelin levels but not GH, IGF-1 and IGFBP-3 levels are
altered in patients with fibromyalgia syndrome. Joint Bone Spine
2007; 74(5):477-81.
Abstract: INTRODUCTION: Both hypothalamo-pituitary-insulin-like
growth factor-1 (IGF-1) axis and ghrelin levels may be altered
in fibromyalgia syndrome (FMS) due to increased somatostatin
tone. The aim of this study is to compare
hypothalamo-pituitary-IGF-1 axis, ghrelin concentrations and
their relations in premenopausal women with FMS and
premenopausal healthy controls. METHODS: Seventy-five women (47
FMS and 28 healthy women) were enrolled in the study. Fasting
plasma glucose, serum growth hormone (GH), insulin, C-peptide,
IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3)
and ghrelin levels were measured. Depressive symptoms were
assessed using beck depression inventory. Pain intensity and
sleep disturbance were recorded on a visual analog scale. The
activity of daily living was assessed by fibromyalgia impact
questionnaire. RESULTS: There were no significant differences in
GH, IGF-1, IGFBP-3, glucose, insulin, and C-peptide levels
between patients and controls (p>0.05), whereas ghrelin levels
were significantly lower in patients than controls (p<0.05).
Ghrelin levels were not correlated with GH, IGF-1, IGFBP-3,
glucose, insulin, and C-peptide levels while they were
positively correlated with tender point score and sleep
disturbance score and negatively correlated with pain intensity
score. CONCLUSION: Our results suggest that low levels of
ghrelin in FMS are not related to the changes in
hypothalamo-pituitary-IGF-1 axis but may be related to some
symptoms of FMS. Our results need to be clarified by further
studies
(47) Babu AS, Mathew E, Danda D, Prakash H. Management
of patients with fibromyalgia using biofeedback: a randomized
control trial. Indian J Med Sci 2007; 61(8):455-61.
Abstract: OBJECTIVE: Fibromyalgia syndrome (FMS) is a chronic
rheumatological condition which could be characterized by
generalized pain and fatigue. Cognitive and behavioral therapy
has been found to be a suitable technique in the management of
FMS. This study intends to evaluate the efficacy of
electromyography (EMG) biofeedback to reduce pain in patients
with FMS. MATERIALS AND METHODS: A randomized controlled trial
involving two groups of FMS patients, one receiving EMG
biofeedback and the other a sham biofeedback, was carried out.
The assessment tools included in the study were fibromyalgia
impact questionnaire (FIQ), visual analogue scale (VAS),
six-minute walk test (SMWT) and number of tender points; and
tenderness of each tender point was done for both the groups.
STATISTICS: A Student's 't' test was used to study the test for
significance. RESULTS: After using biofeedback, the mean VAS
scores and the mean number of tender points were found to be 3
out of 10 and 6 out of 18 respectively. Subjective analysis from
both groups showed improvement in physical and psychological
realms. Statistical significance. CONCLUSION: Biofeedback as a
treatment modality reduces pain in patients with FMS, along with
improvements in FIQ, SMWT and the number of tender points
(48) Yazici Y. Monitoring outcomes of arthritis and
longitudinal data collection in routine care using a patient
questionnaire that incorporates a clinical note on one piece of
paper. Best Pract Res Clin Rheumatol 2007; 21(4):629-36.
Abstract: Patient questionnaires are the quantitative tools
available to rheumatologists to monitor their patients' health
status and responses to therapy. The Health Assessment
Questionnaire (HAQ) and its derivatives have been shown to be
the most significant predictors of functional and work
disability, costs, joint replacement surgery, and mortality;
generally at higher levels of significance than joint counts,
radiographs, and laboratory tests. Every encounter of a patient
with a rheumatologist provides an opportunity to collect data.
Yet patient questionnaires, which can be used in all rheumatic
diseases, including osteoarthritis, systemic lupus
erythematosus, fibromyalgia, scleroderma, and ankylosing
spondylitis, are not included in routine care by most
rheumatologists. Questionnaires can be adapted to include a
simple subjective-objective-assessment-plan (SOAP) clinical
encounter note that helps with data entry and also provides all
the necessary information for clinical decision making in one
sheet of paper. Data that are feasible to collect in clinical
care provide the optimal approach to assessing quantitatively
how patients are doing. If data are not collected and recorded,
that opportunity, on that day, is lost forever. Rheumatologists
would find it valuable to adapt questionnaires to the care they
provide for all their patients, to document and improve the care
they provide, and add quantitative data to standard clinical
care
(49) van Wilgen CP, Bloten H, Oeseburg B. Results of a
multidisciplinary program for patients with fibromyalgia
implemented in the primary care. Disabil Rehabil 2007;
29(15):1207-13.
Abstract: PURPOSE: Fibromyalgia is a syndrome of unknown origin
with a high prevalence. Multimodal approaches seem to be the
treatment of choice in fibromyalgia. A multidisciplinary program
was developed and implemented for patients with fibromyalgia in
the primary care setting. The program included education (seven
sessions) and physical therapy (25 sessions). METHOD: Patients
were referred to the program by their general practitioner or by
a medical specialist. A prospective non-controlled treatment
study was performed, patients were evaluated before, after and
three months after the program (single group time series
design). The following measurements were performed: The
Fibromyalgia Impact Questionnaire, RAND 36, the Pain Coping and
Cognition List, the Tampa scale for kinesiophobia, two physical
tests and a qualitative evaluation. Data of 65 patients with
fibromyalgia were analysed, of whom 97% were female. The mean
age was 44 and the mean duration of pain was nine years.
RESULTS: Data of 65 patients with fibromyalgia were analysed,
patients significantly improved on the domains feeling good,
pain, fatigue, stiffness, quality of life, catastrophizing and
on the physical tests. CONCLUSION: The multidisciplinary program
fibromyalgia implemented in primary care seems feasible and the
results are promising
(50) Carville SF, rendt-Nielsen S, Bliddal H, Blotman F,
Branco JC, Buskila D et al. EULAR evidence-based recommendations
for the management of fibromyalgia syndrome. Ann Rheum Dis 2008;
67(4):536-41.
Abstract: OBJECTIVE: To develop evidence-based recommendations
for the management of fibromyalgia syndrome. METHODS: A
multidisciplinary task force was formed representing 11 European
countries. The design of the study, including search strategy,
participants, interventions, outcome measures, data collection
and analytical method, was defined at the outset. A systematic
review was undertaken with the keywords "fibromyalgia",
"treatment or management" and "trial". Studies were excluded if
they did not utilise the American College of Rheumatology
classification criteria, were not clinical trials, or included
patients with chronic fatigue syndrome or myalgic
encephalomyelitis. Primary outcome measures were change in pain
assessed by visual analogue scale and fibromyalgia impact
questionnaire. The quality of the studies was categorised based
on randomisation, blinding and allocation concealment. Only the
highest quality studies were used to base recommendations on.
When there was insufficient evidence from the literature, a
Delphi process was used to provide basis for recommendation.
RESULTS: 146 studies were eligible for the review. 39
pharmacological intervention studies and 59 non-pharmacological
were included in the final recommendation summary tables once
those of a lower quality or with insufficient data were
separated. The categories of treatment identified were
antidepressants, analgesics, and "other pharmacological" and
exercise, cognitive behavioural therapy, education, dietary
interventions and "other non-pharmacological". In many studies
sample size was small and the quality of the study was
insufficient for strong recommendations to be made. CONCLUSIONS:
Nine recommendations for the management of fibromyalgia syndrome
were developed using a systematic review and expert consensus
(51) McVeigh JG, Finch MB, Hurley DA, Basford JR, Sim J,
Baxter GD. Tender point count and total myalgic score in
fibromyalgia: changes over a 28-day period. Rheumatol Int 2007;
27(11):1011-8.
Abstract: Tender point count (TPC) is central to fibromyalgia
syndrome (FMS), and with total myalgic score (TMS) is often used
to monitor the patient's condition. This study aimed to
determine the stability of TPC and TMS over time, and to examine
how well these measures reflected patients' perceptions of their
condition. Twenty-four patients with FMS completed the
Fibromyalgia Impact Questionnaire (FIQ) and a visual analogue
scale (VAS) measuring well-being, at entrance into the study,
and 7 and 28 days later. There was no significant change in TPC
(P = 0.074), FIQ score (P = 0.291) or VAS (P = 0.079) of
well-being with time. However, mean TMS score did change over
time (P = 0.021). There was no correlation between total FIQ
score and the other measures (all P-values > 0.05). The
significant change in TMS over time may reflect the natural
fluctuation in the clinical presentation of FMS
(52) Walitt B, Roebuck-Spencer T, Esposito G, Atkins F,
Bleiberg J, Foster G et al. The effects of multidisciplinary
therapy on positron emission tomography of the brain in
fibromyalgia: a pilot study. Rheumatol Int 2007; 27(11):1019-24.
Abstract: Aberrant central neurological functioning is believed
to contribute to the abnormal sensations of fibromyalgia (FM).
This pilot study sought to determine if alterations in regional
brain metabolism from baseline occur in FM after undergoing a
multidisciplinary therapeutic regimen. Regional brain metabolic
activity was estimated using (18)F-fluorodeoxyglucose positron
emission tomography ((18)FDG PET). Nine participants with FM
received an 8-week comprehensive treatment program. Serial
testing with (18)FDG PET and the Fibromyalgia Impact
Questionnaire were performed. Statistical analysis was performed
using repeated Wilcoxon signed rank tests. A clinical
improvement (FIQ median change 20.68, P = 0.005) was noted with
treatment. With treatment, increases in brain metabolism were
noted in various components of the limbic system (P =
0.004-0.1). An increase in limbic metabolism was noted with
concomitant symptomatic improvement, suggesting that the limbic
system attenuates FM symptoms
(53) Matsutani LA, Marques AP, Ferreira EA, Assumpcao A,
Lage LV, Casarotto RA et al. Effectiveness of muscle stretching
exercises with and without laser therapy at tender points for
patients with fibromyalgia. Clin Exp Rheumatol 2007;
25(3):410-5.
Abstract: OBJECTIVE: To assess the efficiency of a treatment
composed of muscle stretching exercises, associated or not to
laser therapy at tender points, for patients with fibromyalgia
(FM), in view of bettering their quality of life. METHODS:
Twenty FM patients were randomly assigned to two groups: one
submitted to laser therapy and stretching (LSG, n=10), and the
other only to stretching exercises (SG, n=10). The visual analog
scale of pain (VAS) and dolorimetry at tender points were used
to assess pain; life quality was evaluated by means of the
Fibromyalgia Impact Questionnaire (FIQ) and the 36-item
Short-Form Health Survey (SF-36). RESULTS: After the treatment
program, both in LSG and SG were detected pain reduction, higher
pain threshold at tender points (all p<0.01), lower mean FIQ
scores, and higher SF-36 mean scores (all p<0.05). No
significant differences were found between both groups.
CONCLUSION: The stretching exercises program proposed is
efficient to reduce pain and painful sensibility at tender
points, thus enhancing patients' quality of life. Laser therapy
has not shown advantages when added to muscle stretching
exercises
(54) Tomas-Carus P, Hakkinen A, Gusi N, Leal A, Hakkinen
K, Ortega-Alonso A. Aquatic training and detraining on fitness
and quality of life in fibromyalgia. Med Sci Sports Exerc 2007;
39(7):1044-50.
Abstract: PURPOSE: To evaluate the effects of a 12-wk period of
aquatic training and subsequent de |