title: A randomized controlled pilot study of the therapeutic effects of yoga in people with Parkinson's disease Follow-up of Yoga of Awareness for Fibromyalgia: Results at 3 Months and Replication in the Wait-list Group A protocol and pilot study for managing fibromyalgia with yoga and meditation. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Patients with fibromyalgia display less functional connectivity in the brain’s pain inhibitory network A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia Effects of yoga and the addition of Tui Na in patients with fibromyalgia. Restorative yoga for women with breast cancer: findings from a randomized pilot study. Testing a tool for assessing the risk of bias for nonrandomized studies showed moderate reliability and promising validity. Gentle Hatha yoga and reduction of fibromyalgia-related symptoms: a preliminary report. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
abstract: Background : Exercise can be beneficial for cardiopulmonary , musculoskeletal or neurological systems , and other factors including mood , and may be beneficial in reducing fall risks , dementia and variables associated with quality of life ( QOL ) . Parkinson 's disease ( PD ) produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in st and ard exercise programs . Alternative forms of exercise such as yoga may be successful in improving physical function , QOL and physiological variables for overall well-being . Aim : This r and omized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD . Methods and Material s : Thirteen people with stage 1 - 2 PD were r and omized to either a yoga ( n = 8) or a control group ( n = 5 ) . The yoga group participated in twice-weekly yoga sessions for 12 weeks . Participants were tested at baseline , and at 6 and 12 weeks using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , clinical measures of health-related QOL and physiological measures . Results : Significant improvement in UPDRS scores ( P = .006 ) , diastolic blood pressure ( P = 0.036 ) and average forced vital capacity ( P = 0.03 ) was noted in the yoga group over time . Changes between groups were also noted in two SF-36 subscales . Positive trends of improvement were noted in depression scores ( P = 0.056 ) , body weight ( P = 0.056 ) and forced expiratory volume ( P = 0.059 ) . Yoga participants reported more positive symptom changes including immediate tremor reduction . Conclusions : The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1 - 2 PD . Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD Objectives : Published preliminary findings from a r and omized-controlled trial suggest that an 8-week Yoga of Awareness intervention may be effective for improving symptoms , functional deficits , and coping abilities in fibromyalgia . The primary aims of this study were to evaluate the same intervention ’s posttreatment effects in a wait-list group and to test the intervention ’s effects at 3-month follow-up in the immediate treatment group . Methods : Unpaired t tests were used to compare data from a per protocol sample of 21 women in the immediate treatment group who had completed treatment and 18 women in the wait-list group who had completed treatment . Within-group paired t tests were performed to compare posttreatment data with 3-month follow-up data in the immediate treatment group . The primary outcome measure was the Fibromyalgia Impact Question naire Revised ( FIQR ) . Multilevel r and om-effects models were also used to examine associations between yoga practice rates and outcomes . Results : Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment group , with the FIQR Total Score improving by 31.9 % across the 2 groups . Follow-up results showed that patients sustained most of their posttreatment gains , with the FIQR Total Score remaining 21.9 % improved at 3 months . Yoga practice rates were good , and more practice was associated with more benefit for a variety of outcomes . Discussion : These findings indicate that the benefits of Yoga of Awareness in fibromyalgia are replicable and can be maintained 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 Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Background There is evidence for augmented processing of pain and impaired endogenous pain inhibition in Fibromyalgia syndrome ( FM ) . In order to fully underst and the mechanisms involved in FM pathology , there is a need for closer investigation of endogenous pain modulation . In the present study , we compared the functional connectivity of the descending pain inhibitory network in age-matched FM patients and healthy controls (HC).We performed functional magnetic resonance imaging ( fMRI ) in 42 subjects ; 14 healthy and 28 age-matched FM patients ( 2 patients per HC ) , during r and omly presented , subjectively calibrated pressure pain stimuli . A seed-based functional connectivity analysis of brain activity was performed . The seed coordinates were based on the findings from our previous study , comparing the fMRI signal during calibrated pressure pain in FM and HC : the rostral anterior cingulate cortex ( rACC ) and thalamus . Results FM patients required significantly less pressure ( kPa ) to reach calibrated pain at 50 mm on a 0–100 visual analogue scale ( p < .001 , two-tailed ) . During fMRI scanning , the rACC displayed significantly higher connectivity to the amygdala , hippocampus , and brainstem in healthy controls , compared to FM patients . There were no regions where FM patients showed higher rACC connectivity . Thalamus showed significantly higher connectivity to the orbitofrontal cortex in healthy controls but no regions showed higher thalamic connectivity in FM patients . Conclusion Patients with FM displayed less connectivity within the brain ’s pain inhibitory network during calibrated pressure pain , compared to healthy controls . The present study provides brain-imaging evidence on how brain regions involved in homeostatic control of pain are less connected in FM patients . It is possible that the dysfunction of the descending pain modulatory network plays an important role in maintenance of FM pain and our results may translate into clinical implication s by using the functional connectivity of the pain modulatory network as an objective measure of pain dysregulation & NA ; A mounting body of literature recommends that treatment for fibromyalgia ( FM ) encompass medications , exercise and improvement of coping skills . However , there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping . The aim of this r and omized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping . A sample of 53 female FM patients were r and omized to the 8‐week Yoga of Awareness program ( gentle poses , meditation , breathing exercises , yoga‐based coping instructions , group discussion s ) or to wait‐listed st and ard care . Data were analyzed by intention to treat . At post‐treatment , women assigned to the yoga program showed significantly greater improvements on st and ardized measures of FM symptoms and functioning , including pain , fatigue , and mood , and in pain catastrophizing , acceptance , and other coping strategies . This pilot study provides promising support for the potential benefits of a yoga program for women with FM OBJECTIVES This study aim ed 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 r and omized 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 su bmi tted to manipulative techniques of Tui Na . OUTCOME MEASURE Outcome measures comprised the Fibromyalgia Impact Question naire ( 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 OBJECTIVES Restorative yoga ( RY ) is a gentle type of yoga that may be beneficial for cancer patients and post-treatment survivors . Study goals were : to determine the feasibility of implementing a RY intervention for women with breast cancer ; and to examine group differences in self-reported emotional , health-related quality of life , and symptom outcomes . METHODS Women with breast cancer ( n=44 ; mean age 55.8 years ) enrolled in this study ; 34 % were actively undergoing cancer treatment . Study participants were r and omized to the intervention ( 10 weekly 75-minute RY classes ) or a waitlist control group . Participants completed question naires at Week 0 ( baseline ) and Week 10 ( immediately post-intervention for the yoga group ) . RESULTS Group differences favoring the yoga group were seen for mental health , depression , positive affect , and spirituality ( peace/meaning ) . Significant baseline*group interactions were observed for negative affect and emotional well-being . Women with higher negative affect and lower emotional well-being at baseline derived greater benefit from the yoga intervention compared to those with similar values at baseline in the control group . The yoga group demonstrated a significant within-group improvement in fatigue ; no significant difference was noted for the control group . CONCLUSIONS Although limited by sample size , these pilot data suggest potential benefit of RY on emotional outcomes and fatigue in cancer patients . This study demonstrates that a RY intervention is feasible for women with breast cancer ; implication s for study design and implementation are noted with an emphasis on program adoption and participant adherence OBJECTIVES To develop and vali date a new risk-of-bias tool for nonr and omized studies ( NRSs ) . STUDY DESIGN AND SETTING We developed the Risk of Bias Assessment Tool for Nonr and omized Studies ( RoBANS ) . A validation process with 39 NRSs examined the reliability ( interrater agreement ) , validity ( the degree of correlation between the overall assessment s of RoBANS and Method ological Index for Nonr and omized Studies [ MINORS ] , obtained by plotting the overall risk of bias relative to effect size and funding source ) , face validity with eight experts , and completion time for the RoBANS approach . RESULTS RoBANS contains six domains : the selection of participants , confounding variables , the measurement of exposure , the blinding of the outcome assessment s , incomplete outcome data , and selective outcome reporting . The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial . There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS . The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies . The mean time required to complete RoBANS was approximately 10 min . The external experts who were interviewed evaluated RoBANS as a " fair " assessment tool . CONCLUSIONS RoBANS shows moderate reliability , promising feasibility , and validity . The further refinement of this tool and larger validation studies are required OBJECTIVES AND METHODS This study examined whether gentle Hatha yoga reduced  fibromyalgia-related symptoms  for a convenience sample of 10 participants ranging in age from 39 to 64 years who received yoga instruction  2 times per week for 8 weeks . METHODS Respondents completed the Fibromyalgia Impact Question naire 1 time per week and provided weekly journal reports regarding their health status . Pre- and post-intervention manual tender point evaluations were also conducted . RESULTS Findings provide evidence of association between participating in gentle Hatha yoga classes and reduced fibromyalgia - related symptoms . CONCLUSIONS Additional r and omized controlled trials with larger sample sizes and greater empirical rigor are needed to more fully underst and this relationship The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials
target: Findings reveal a lack of reporting of intervention details , the need to report a disease-specific rationale for selection of the particular yoga style used for the intervention , and that a limited number of yoga styles have been investigated in persons with fibromyalgia
background: OBJECTIVE The objective of this article was to present a methodology incorporating existing guidelines and tools for systematic review s and to evaluate the Delphi survey 33 key component recommendations of yoga interventions for musculoskeletal conditions as a tool for a systematic review in fibromyalgia studies .