Fibromyalgia: the role of sleep in affect and in negative event reactivity and recovery. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. The Effects of Nabilone on Sleep in Fibromyalgia: Results of a Randomized Controlled Trial Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update A randomized controlled trial of dehydroepiandrosterone in postmenopausal women with fibromyalgia. The Durability of Cognitive Behavioral Therapy for Insomnia in Patients with Chronic Pain Changes in pain coping, catastrophizing, and coping efficacy after cognitive-behavioral therapy in children and adolescents with juvenile fibromyalgia. Reduction of fibromyalgia symptoms through intravenous nutrient therapy: results of a pilot clinical trial. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Double-blind, multicenter trial comparing acetyl l-carnitine with placebo in the treatment of fibromyalgia patients. Multicomponent cognitive-behavioral group therapy with hypnosis for the treatment of fibromyalgia: long-term outcome. Depressed mood impedes pain treatment response in patients with fibromyalgia. Theory of Mind and Emotional Functioning in Fibromyalgia Syndrome: An Investigation of the Relationship between Social Cognition and Executive Function Long-term Maintenance of Response Across Multiple Fibromyalgia Symptom Domains in a Randomized Withdrawal Study of Pregabalin A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. Comparative effectiveness of CBT interventions for co-morbid chronic pain & insomnia: a pilot study. Effects of thermal therapy combining sauna therapy and underwater exercise in patients with fibromyalgia. Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments What Makes Patients with Fibromyalgia Feel Better? Correlations Between Patient Global Impression of Improvement and Changes in Clinical Symptoms and Function: A Pooled Analysis of 4 Randomized Placebo-controlled Trials of Duloxetine Chronic pain in older adults: a controlled pilot trial of a brief cognitive-behavioural group treatment. A protocol and pilot study for managing fibromyalgia with yoga and meditation.
OBJECTIVE Fibromyalgia ( FM ) syndrome is a chronic pain condition characterized by diffuse muscle pain , increased negative mood , and sleep disturbance . Until recently , sleep disturbance in persons with FM has been modeled as the result of the disease process or its associated pain . The current study examined sleep disturbance ( i.e. , sleep duration and sleep quality ) as a predictor of daily affect , stress reactivity , and stress recovery . DESIGN AND MEASURES A hybrid of daily diary and ecological momentary assessment methodology was used to evaluate the psychosocial functioning of 89 women with FM . Participants recorded numeric ratings of pain , fatigue , and positive and negative affect 3 times throughout the day for 30 consecutive days . At the end of each day , participants completed daily diary records of positive and negative life events . In addition , participants reported on their sleep duration and sleep quality each morning . RESULTS After accounting for the effects of positive events , negative events , and pain on daily affect scores , it was found that sleep duration and quality were prospect ively related to affect and fatigue . Furthermore , the effects of inadequate sleep on negative affect were cumulative . In addition , an inadequate amount of sleep prevented affective recovery from days with a high number of negative events . CONCLUSIONS These results lend support to the hypothesis that sleep is a component of allostatic load and has an upstream role in daily functioning BACKGROUND Insomnia is common and debilitating to fibromyalgia ( FM ) patients .  Cognitive-behavioral therapy ( CBT ) is effective for many types of patients with insomnia , but has yet to be tested with FM patients . This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms . METHODS This r and omized clinical trial enrolled 47 FM patients with chronic insomnia complaints . The study compared CBT , sleep hygiene ( SH ) instructions , and usual FM care alone . Outcome measures were subjective ( sleep logs ) and objective ( actigraphy ) total sleep time , sleep efficiency , total wake time , sleep latency , wake time after sleep onset , and question naire measures of global insomnia symptoms , pain , mood , and quality of life . RESULTS Forty-two patients completed baseline and continued into treatment . Sleep logs showed CBT-treated patients achieved nearly a 50 % reduction in their nocturnal wake time by study completion , whereas SH therapy- and usual care-treated patients achieved only 20 % and 3.5 % reductions on this measure , respectively . In addition , 8 ( 57 % ) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 ( 17 % ) of 12 SH therapy recipients and 0 % of the usual care group . Comparable findings were noted for similar actigraphic improvement criteria . The SH therapy patients showed favorable outcomes on measures of pain and mental well-being . This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies . CONCLUSIONS Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients . Larger clinical trials of this intervention with FM patients seem warranted Sleep disturbances play an important role in the exacerbation of pain and other troubling symptoms reported by patients with fibromyalgia ( FM ) . The objective of this trial was to analyze the efficacy of a cognitive-behavioral therapy for insomnia ( CBT-I ) versus a sleep hygiene ( SH ) education program at improving sleep and other clinical manifestations in FM . Sixty-four FM women with insomnia were r and omly assigned to the CBT-I or the SH groups , and 59 completed the treatments ( 30 in the CBT-I group and 29 in the SH group ) . Participants completed several self-report question naires at pre- , post-treatment and follow-ups . The CBT-I group reported significant improvements at post-treatment in several sleep variables , fatigue , daily functioning , pain catastrophizing , anxiety and depression . The SH group only improved significantly in subjective sleep quality . Patients in the CBT-I group showed significantly greater changes than those in the SH group in most outcome measures . The findings underscore the usefulness of CBT-I in the multidisciplinary management of FM OBJECTIVE Juvenile fibromyalgia syndrome ( FMS ) is a chronic musculoskeletal pain disorder in children and adolescents for which there are no evidence -based treatments . The objective of this multisite , single-blind , r and omized clinical trial was to test whether cognitive-behavioral therapy ( CBT ) was superior to fibromyalgia ( FM ) education in reducing functional disability , pain , and symptoms of depression in juvenile FMS . METHODS Participants were 114 adolescents ( ages 11 - 18 years ) with juvenile FMS . After receiving stable medications for 8 weeks , patients were r and omized to either CBT or FM education and received 8 weekly individual sessions with a therapist and 2 booster sessions . Assessment s were conducted at baseline , immediately following the 8-week treatment phase , and at 6-month followup . RESULTS The majority of patients ( 87.7 % ) completed the trial per protocol . Intent-to-treat analyses showed that patients in both groups had significant reductions in functional disability , pain , and symptoms of depression at the end of the study , and CBT was significantly superior to FM education in reducing the primary outcome of functional disability ( mean baseline to end-of-treatment difference between groups 5.39 [ 95 % confidence interval 1.57 , 9.22 ] ) . Reduction in symptoms of depression was clinical ly significant for both groups , with mean scores in the range of normal/nondepressed by the end of the study . Reduction in pain was not clinical ly significant for either group ( < 30 % decrease in pain ) . There were no study -related adverse events . CONCLUSION In this controlled trial , CBT was found to be a safe and effective treatment for reducing functional disability and symptoms of depression in adolescents with juvenile FMS BACKGROUND : Sleep disorders affect many patients with chronic pain conditions . Cannabis has been reported by several patient population s to help sleep . We evaluated the safety and efficacy of nabilone , a synthetic cannabinoid , on sleep disturbance in fibromyalgia ( FM ) , a disease characterized by widespread chronic pain and insomnia . METHODS : We conducted a r and omized , double-blind , active-control , equivalency crossover trial to compare nabilone ( 0.5–1.0 mg before bedtime ) to amitriptyline ( 10–20 mg before bedtime ) in patients with FM with chronic insomnia . Subjects received each drug for 2 wk with a 2-wk washout period . The primary outcome was sleep quality , measured by the Insomnia Severity Index and the Leeds Sleep Evaluation Question naire . Secondary outcomes included pain , mood , quality of life , and adverse events ( AEs ) . RESULTS : Thirty-one subjects were enrolled and 29 completed the trial ( 26 women , mean age 49.5 yr ) . Although sleep was improved by both amitriptyline and nabilone , nabilone was superior to amitriptyline ( Insomnia Severity Index difference = 3.2 ; 95 % confidence interval = 1.2–5.3 ) . Nabilone was marginally better on the restfulness ( Leeds Sleep Evaluation Question naire difference = 0.5 [ 0.0–1.0 ] ) but not on wakefulness ( difference = 0.3 [ −0.2 to 0.8 ] ) . No effects on pain , mood , or quality of life were observed . AEs were mostly mild to moderate and were more frequent with nabilone . The most common AEs for nabilone were dizziness , nausea , and dry mouth . CONCLUSIONS : Nabilone is effective in improving sleep in patients with FM and is well tolerated . Low-dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline . Longer trials are needed to determine the duration of effect and to characterize long-term safety Following development of the core domain set for fibromyalgia ( FM ) in Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) meetings 7 to 9 , the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains , utilizing outcome indices of these domains from archived r and omized clinical trials in FM . Possible clinical domains that could be included in a responder index and disease activity score include pain , fatigue , sleep disturbance , cognitive dysfunction , mood disturbance , tenderness , stiffness , and functional impairment . Outcome measures for these domains demonstrate good to adequate psychometric properties , although measures of cognitive dysfunction need to be further developed . The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work , but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions , nor are there objective markers that define thresholds of severity or response to treatment . The process of developing c and i date dichotomous responder definitions and continuous quantitative disease activity measures is described , along with participant discussion s from OMERACT 10 . Final results of this work will be published in a separate report pending completion of analyses OBJECTIVE Patients with fibromyalgia ( FM ) consistently have adrenal hyporesponsiveness and low dehydroepi and rosterone ( DHEA ) levels . DHEA is promoted for and used by patients with FM . We tested the efficacy and safety of DHEA supplementation in ameliorating the symptoms of FM . METHODS In a double-blind crossover study , postmenopausal women with FM were r and omized to DHEA supplementation  ( 50 mg/day ) or placebo for 3 months , with a one-month washout period in between . Patients were assessed monthly for well-being and pain and by medical evaluations at the beginning and the end of each treatment period . The primary outcome was well being ; secondary outcomes were pain , fatigue , cognition , sexuality , functional impairment , depression , and anxiety . RESULTS A total of 52 patients were r and omized , 47 patients completed the  DHEA  treatment period , and 45 the placebo treatment period . After 3 months of treatment with 50 mg of DHEA , median DHEA sulfate blood levels had tripled , but there was no improvement in well-being , pain , fatigue , cognitive dysfunction , functional impairment , depression , or anxiety , nor in objective measurements made by physicians . And rogenic side effects ( greasy skin , acne , and increased growth of body hair ) were more common during the DHEA treatment period ( p = 0.02 ) . CONCLUSION DHEA does not improve quality of life , pain , fatigue , cognitive function , mood , or functional impairment in FM The purpose of this study was to assess the long-term ( six months ) effects of cognitive behavioral therapy for insomnia ( CBT-I ) in patients with chronic pain . The results of the pre-post treatment effects have been reported previously . The therapy was delivered by an advanced practice nurse in a research setting using a parallel-group , r and omized , single blind trial of CBT-I with a contact/measurement control condition . Outcomes included sleep diary , the Insomnia Severity Index , the Multidimensional Pain Inventory , the Beck Depression Inventory , the Profile of Mood States-short form , and the Pain Disability Index . Measurement time points were end-of-treatment , three-month and six-month posttherapy . Subjects receiving CBT-I ( n = 19 ) , as compared to control subjects ( n = 9 ) , did not exhibit any significant group by visit effects on measures of sleep , pain , mood , or function after end of treatment . However , subjects in the treatment group exhibited statistically ( P = 0.03 ) and clinical ly significant improvement in total sleep time ( 23 minutes ) over the six months following treatment . In this paper , cognitive behavioral therapy directed to improve insomnia was successfully delivered to patients with moderate-to-severe chronic pain and the positive effects of CBT-I continued to improve despite the presence of continued moderate-to-severe pain UNLABELLED A recent r and omized multisite clinical trial found that cognitive-behavioral therapy ( CBT ) was significantly more effective than fibromyalgia education ( FE ) in reducing functional disability in adolescents with juvenile fibromyalgia ( JFM ) . The primary objective of this study was to examine the psychological processes of CBT effectiveness by evaluating changes in pain coping , catastrophizing , and coping efficacy and to test these changes as mediators of continued improvements in functional disability and depressive symptoms at 6-month follow-up . One hundred adolescents ( 11 - 18 years old ) with JFM completed the clinical trial .  Coping , catastrophizing , and coping efficacy ( Pain Coping Question naire ) and the outcomes of functional disability ( Functional Disability Inventory ) and depressive symptoms ( Children 's Depression Inventory ) were measured at baseline , posttreatment , and 6-month follow-up . Participants in both conditions showed significant improvement in coping , catastrophizing , and efficacy by the end of the study , but significantly greater improvements were found immediately following treatment for those who received CBT .  Treatment gains were maintained at follow-up . Baseline to posttreatment changes in coping , catastrophizing , and efficacy were not found to mediate improvements in functional disability or depressive symptoms from posttreatment to follow-up . Future directions for underst and ing mechanisms of  CBT effectiveness in adolescents with chronic pain  are discussed . PERSPECTIVE CBT led to significant improvements in pain coping , catastrophizing , and efficacy that were sustained over time in adolescents with juvenile fibromyalgia . Clinicians treating adolescents with JFM should focus on teaching a variety of adaptive coping strategies to help patients simultaneously regain functioning and improve mood OBJECTIVE To evaluate the effectiveness of a modified Myers ' formula of intravenous nutrient therapy ( IVNT ) on the symptoms of fibromyalgia ( FM ) in therapy-resistant FM patients . METHODS In this pilot clinical trial , 7 participants with therapy resistant FM were given IVNT once per week for 8 weeks . Patient 's pain levels , fatigue , and activities of daily living were evaluated weekly . RESULTS All participants reported decreased pain levels , decreased fatigue , and increased activities of daily living . Participants noted increased energy levels within 24 - 48 hours of the initial infusion . At the end of the study , all participants reported increased energy and activities of daily living as well as a 60 % reduction in pain ( P=.005 ) and an 80 % decrease in fatigue ( P=-.005 ) . No participants , however , reported complete or lasting resolution of pain or fatigue . No side effects were reported . DISCUSSION Anecdotal reports have indicated benefit for IVNT for patients with chronic pain , including FM . However , except for 2 reports , the medical literature is devoid of any studies of IVNT for the treatment of FM . In this pilot study , 7 participants received  IVNT  once a week for 8 weeks . All participants had long-st and ing FM ( at least 8 years ) and had tried conventional therapies , such as antidepressants , nonsteroidal anti-inflammatory drugs , and exercise , without significant or lasting relief . All had improvement in symptoms and increases in their activities of daily living , although no participant reported complete resolution of symptoms .  IVNT appears to be safe to reduce FM symptoms OBJECTIVE Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold . Other prominent symptoms include disordered sleep and fatigue . FMS affects an estimated 2 % of the population , predominantly women . This trial was design ed to evaluate the efficacy and safety of pregabalin , a novel alpha(2)-delta lig and , for treatment of symptoms associated with FMS . METHODS This multicenter , double-blind , 8-week , r and omized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS . The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group . RESULTS Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0 - 10 scale ) ( P < /= 0.001 ) , and significantly more patients in this group had > /=50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) . Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change .  Pregabalin at 450 mg/day improved several domains of health-related quality of life . Dizziness and somnolence were the most frequent adverse events . Rates of discontinuation due to adverse events were similar across all 4 treatment groups . CONCLUSION Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo . Pregabalin was well tolerated and improved global measures and health-related quality of life OBJECTIVE Fibromyalgia ( FMS ) is a chronic syndrome characterized by widespread pain , troubled sleep , disturbed mood , and fatigue . Several analgesic strategies have been evaluated but the results are moderate and inconsistent . Antidepressant agents are now considered the treatment of choice in most patients . It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine . In this multicenter r and omized clinical trial we evaluated the efficacy of acetyl L-carnitine ( LAC ) in patients with overt FMS . METHODS One hundred and two patients meeting the American College of Rheumatology criteria for FMS were r and omized into the study . The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular ( i.m . ) injection of either 500 mg LAC or placebo for 2 weeks . During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo . The patients were seen during treatment after 2 ( visit 3 ) , 6 ( visit 4 ) and 10 weeks ( visit 5 ) . The patients were also visited 4 weeks after treatment discontinuation ( follow-up visit ) . Outcome measures included the number of positive tender points , the sum of pain threshold ( kg/cm2 or " total myalgic score " ) , the Short Form 36 ( SF36 ) , a 100 mm visual analog scale ( VAS ) for self-perceived stiffness , fatigue , tiredness on awakening , sleep , work status , depression , and muscular-skeletal pain , and the Hamilton depression scale . RESULTS The " total myalgic score " and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment . At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference . Most VAS scores significantly improved in both groups . A statistically significant between-group difference was observed for depression and musculo-skeletal pain . Significantly larger improvements in SF36 question naire were observed in LAC than in placebo group for most parameters . Treatment was well-tolerated . CONCLUSION Although this experience deserves further studies , these results indicate that LAC may be of benefit in patients with FMS , providing improvement in pain as well as the general and mental health of these patients UNLABELLED This study compared the efficacy of 2 psychological treatments for fibromyalgia with each other and with st and ard care . Ninety-three patients with fibromyalgia ( FM ) were r and omly assigned to 1 of the 3 experimental conditions : 1 ) multicomponent cognitive-behavioral therapy ( CBT ) ; 2 ) multicomponent CBT with hypnosis ; and 3 ) pharmacological treatment ( st and ard care control group ) . The outcome measures of pain intensity , catastrophizing , psychological distress , functionality , and sleep disturbances were assessed before treatment , immediately after treatment , and at 3- and 6-month follow-up visits . CBT and CBT with hypnosis participants received the st and ard pharmacological management plus 14 weekly , 120-minute-long sessions of psychological treatment . All but 1 session followed a group format ; the remaining session was individual . The analyses indicated that : 1 ) patients with FM who received multicomponent CBT alone or multicomponent CBT with hypnosis showed greater improvements than patients who received only st and ard care ; and 2 ) adding hypnosis enhanced the effectiveness of multicomponent CBT . This study presents new evidence about the efficacy of multicomponent CBT for FM and about the additional effects of hypnosis as a complement to CBT . The relevance and implication s of the obtained results are discussed . PERSPECTIVE This article highlights the beneficial effects of adding hypnosis in a multicomponent cognitive-behavioral group treatment of fibromyalgia patients . Also , this research showed that by adding hypnosis the length of treatment did not increase OBJECTIVE To investigate prognostic factors in the course of the fibromyalgia syndrome ( FM ) from baseline to post-treatment . METHODS Fifty-seven patients with FM were examined in a r and omized intervention study . Pre-treatment variables were entered into linear regression analyses : gender , age , duration of disease , allocation to treatment , pain distribution ( based on a patient-made drawing ) , fatigue , sleep disturbance , and depressed mood ( based on visual analog scores ) , with pain distribution at treatment completion as the dependent variable . RESULTS Depressed mood at baseline was a significant predictor of sustained widespread pain at treatment completion . CONCLUSION The findings indicate a role for depressed mood as a predictive factor for treatment response Background Fibromyalgia ( FM ) is a syndrome primarily characterised by chronic , widespread musculoskeletal pain . In the aetiology of this syndrome a crucial role is played by complex interactions among biological , genetic , psychological , and socio-cultural factors . Recently , research ers have started to explore emotional functioning in FM , with their attention focused on alexithymia , a personality construct that affects the regulation of a person ’s own emotions . On the other h and , the detection and experience of emotional signals from other people have only been sparsely investigated in FM syndrome and no studies have investigated the ability to represent other people ’s mental states ( i.e. Theory of Mind , ToM ) in these patients . Here we present the first study investigating a large set of social-cognitive abilities , and the possible relationships between these abilities and the performance on executive-function tasks , in a homogenous sample of patients with FM . Methodology Forty women with FM and forty-one healthy women matched for education and age were involved in the study .  Social cognition was assessed with a set of vali date d experimental tasks .  Measures of executive function were used to test the correlations between this dimension and the social-cognitive profile of patients with FM . Relationships between social-cognitive abilities and demographic , clinical and psychological variables were also investigated . Principal Findings Patients with FM have impairments both in the regulation of their own affect and in the recognition of other ’s emotions , as well as in representing other people ’s mental states . No significant correlations were found between social cognition tasks and the subcomponents of the executive function that were analysed . Conclusions The results show the presence of several impairments in social cognition skills in patients with FM , which are largely independent of both executive function deficits and symptoms of psychological distress . The impairments reported highlight the importance of adequately assessing ToM and emotional functioning in clinical practice Objective : To determine the incidence and duration of response of clinical ly meaningful improvements with pregabalin across several key symptoms of fibromyalgia ( FM ) . Methods : This was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled , r and omized , withdrawal study , originally design ed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change ( PGIC ) criteria . Responder criteria for Fibromyalgia Impact Question naire total score ( ≥16-point change ) , Medical Outcomes Study Sleep Scale Sleep Disturbance subscale ( ≥15.8-point change ) , and the 36-item Short-Form Health Survey Vitality scale ( ≥10-point change ) were used to evaluate the incidence and duration of improvements in function , sleep , and fatigue  for pregabalin versus placebo among pain and PGIC responders . A composite responder index consisting of pain , PGIC , function , and sleep endpoints was used to explore multidimensional response . Results : Approximately 80 % of patients meeting pain and PGIC improvement criteria at r and omization had clinical ly meaningful improvement in fatigue , sleep , or function . Higher proportions of patients in the pregabalin group maintained a clinical ly meaningful response , and pregabalin-treated patients had a significantly longer time to loss of therapeutic response  compared with the placebo group . Composite responder Kaplan-Meier analysis , performed with patients demonstrating clinical ly meaningful improvements in pain , PGIC , function , and sleep at r and omization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients . Discussion : The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM ( Clinical Trials.gov registry ID : NCT00151489 ) 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 r and omly 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 Question naire (FIQ)-Total Score . Secondary outcomes included assessment s 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 assessment s 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 clinical ly meaningful benefit to patients with FM INTRODUCTION Chronic pain is difficult to treat and often precedes or exacerbates sleep disturbances such as insomnia . Insomnia , in turn , can amplify the pain experience . Both conditions are associated with inflammatory processes , which may be involved in the bi-directional relationship between pain and sleep . Cognitive behavioral therapy ( CBT ) for pain and CBT for insomnia are evidence based interventions for , respectively , chronic pain and insomnia . The study objectives were to determine the feasibility of combining CBT for pain  and for insomnia and to assess the effects of the combined intervention and the st and alone interventions on pain , sleep , and mood outcomes compared to a control condition . METHODS Twenty-one adults with co-occurring chronic pain and chronic insomnia were r and omized to either CBT for pain , CBT for insomnia , combined CBT for pain and insomnia , or a wait-list control condition . RESULTS The combined CBT intervention was feasible to deliver and produced significant improvements in sleep , disability from pain , depression and fatigue compared to the control condition . Overall , the combined intervention appeared to have a strong advantage over CBT for pain on most outcomes , modest advantage over both CBT for insomnia in reducing insomnia severity in chronic pain patients . DISCUSSION CBT for pain and CBT for insomnia may be combined with good results for patients with co-occurring chronic pain and insomnia Fibromyalgia syndrome ( FMS ) is a chronic disorder that is characterized by widespread pain with localized tenderness . We aim ed to investigate whether thermal therapy combining sauna therapy and underwater exercise improved pain , symptoms , and quality of life ( QOL ) in FMS patients . Forty-four female FMS patients who fulfilled the American College of Rheumatology ( ACR ) criteria received 12-week thermal therapy program comprising sauna therapy once daily for 3 days/week and underwater exercise once daily for 2 days/week . Pain , symptoms , and QOL were assessed using a pain visual analog scale ( VAS ) , a fibromyalgia impact question naire ( FIQ ) , and a short form 36-item question naire ( SF-36 ) , respectively . All of the patients reported significant reductions in pain and symptoms of 31 - 77 % after the 12-week thermal therapy program , which remained relatively stable ( 28 - 68 % ) during the 6-month follow-up period ( that is , the thermal therapy program improved both the short-term and the long-term VAS and FIQ scores ) . Improvements were also observed in the SF-36 score .  Thermal therapy combining sauna therapy and underwater exercise improved the QOL as well as the pain and symptoms of FMS patients The present study focused on the evaluation of the effects of operant behavioural ( OBT ) and cognitive behavioural ( CBT ) treatments for fibromyalgia syndrome ( FMS ) . One hundred and twenty-five patients who fulfilled the American College of Rheumatology criteria for FMS were r and omly assigned to OBT ( n = 43 ) , CBT ( n = 42 ) , or an attention-placebo ( AP ) treatment ( n = 40 ) that consisted of discussion s of FMS-related problems . Assessment s of physical functioning , pain , affective distress , and cognitive and behavioural variables were performed pre-treatment and post-treatment as well as 6 and 12 months post-treatment . Patients receiving the OBT or CBT reported a significant reduction in pain intensity post-treatment ( all Fs > 3.89 , all Ps < 0.01 ) . In addition , the CBT group reported statistically significant improvements in cognitive ( all Fs > 7.95 , all P < 0.01 ) and affective variables ( all Fs > 2.99 , all Ps < 0.02 ) , and the OBT group demonstrated statistically significant improvements in physical functioning and behavioural variables ( all Fs > 5.99 , all Ps < 0.001 ) compared with AP . The AP group reported no significant improvement but actually deterioration in the outcome variables . The post-treatment effects for the OBT and CBT groups were maintained at both the 6- and 12-month follow-ups . These results suggest that both OBT and CBT are effective in treating patients with FMS with some differences in the outcome measures specifically targeted by the individual treatments compared with an unstructured discussion group . The AP group showed that unstructured discussion of FMS-related problems may be detrimental Objective . To investigate the relationship between changes in clinical rating scale items and endpoint Patient Global Impression of Improvement ( PGI-I ) . Methods . Data were pooled from 4 r and omized , double-blind , placebo-controlled studies of duloxetine in patients with fibromyalgia ( FM ) . Variables included in the analyses were those that assessed symptoms in FM domains of pain , fatigue , sleep , cognitive difficulties , emotional well-being , physical function , and impact on daily living . The association of endpoint PGI-I with changes from baseline in individual variables was assessed using Pearson product-moment correlations ( r ) . Stepwise linear regression was used to identify those variables for which changes from baseline were statistically significant independent predictors of the endpoint PGI-I ratings . Results . Changes in pain variables and interference of symptoms with the ability to work were highly correlated ( r ≥ 0.5 or r ≤ −0.5 ) with endpoint PGI-I. Moderate correlation with endpoint PGI-I ( 0.30 ≤ r < 0.5 or −0.5 < r ≤ −0.30 ) included changes in variables that assessed physical functioning , depression , anxiety , fatigue , and several variables related to impact on daily living . Independent predictor variables of endpoint PGI-I identified by stepwise linear regression included assessment s for pain , physical function , vitality , anxiety , social function , and tender point thresholds . Conclusion . In addition to pain reduction , what makes patients with FM feel better may include improvement in fatigue , physical functioning , mood , and impact on daily living . An assessment of these domains may be important in clinical trials of FM and in the management of patients with FM BACKGROUND Chronic pain is a common condition among older adults . While cognitive behaviour therapy ( CBT ) has been tested in numerous studies on adults and children there are fewer studies on older persons . The objective of this study was to investigate the effects of a six-session CBT group treatment for older persons with chronic pain . As a secondary aim we investigated whether treatment credibility was associated with outcome . METHOD We included 21 persons ( mean age = 72.0 years ) who were r and omly allocated to either a waitlist condition or treatment consisting of applied relaxation , with the addition of problem solving , assertiveness , communication strategies , sleep management , and relapse prevention . RESULTS Few statistically significant effects were found on measures of pain , mood , anxiety , and quality of life ; however , a significant treatment effect with a between group effect size of d = 1.0 was observed with respect to perceived ability to function despite the discomfort of pain . CONCLUSION The study provides some preliminary support for the use of group-based CBT with a focus on applied relaxation for older adults with chronic pain Fibromyalgia is a chronic syndrome characterized by widespread pain , sleep disturbance , stiffness , fatigue , headache , and mood disorders . Recent research has result ed in an improved underst and ing of fibromyalgia and its possible causes . This article highlights some of the current research , discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers , and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms . The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness , anxiety , and depression . Significant improvements were also seen in the reported number of days " felt good " and number of days " missed work " because of fibromyalgia . Nonsignificant improvements were seen in measures of pain , fatigue , and how one felt in the morning . Effect sizes were medium to large for most tested areas . This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as st and ard therapies for fibromyalgia
CBTs provided a small incremental benefit over control interventions in reducing pain , negative mood and disability at the end of treatment and at long-term follow-up .
The dropout rates due to any reason did not differ between CBTs and controls
BACKGROUND Fibromyalgia ( FM ) is a clinical ly well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances , cognitive dysfunction and fatigue .
Patients often report high disability levels and negative mood .
Psychotherapies focus on reducing key symptoms , improving daily functioning , mood and sense of personal control over pain .
OBJECTIVES To assess the benefits and harms of cognitive behavioural therapies ( CBTs ) for treating FM at end of treatment and at long-term ( at least six months ) follow-up .