1 518 143 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 2 258 40 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 3 2831 60 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014 4 2852 65 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017 5 2518 51 YOGA COMPARED TO NON-EXERCISE OR PHYSICAL THERAPY EXERCISE ON PAIN, DISABILITY, AND QUALITY OF LIFE FOR PATIENTS WITH CHRONIC LOW BACK PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. BACKGROUND: CHRONIC LOW BACK PAIN (CLBP) IS A COMMON AND OFTEN DISABLING MUSCULOSKELETAL CONDITION. YOGA HAS BEEN PROVEN TO BE AN EFFECTIVE THERAPY FOR CHRONIC LOW BACK PAIN. HOWEVER, THERE ARE STILL CONTROVERSIES ABOUT THE EFFECTS OF YOGA AT DIFFERENT FOLLOW-UP PERIODS AND COMPARED WITH OTHER PHYSICAL THERAPY EXERCISES. OBJECTIVE: TO CRITICALLY COMPARE THE EFFECTS OF YOGA FOR PATIENTS WITH CHRONIC LOW BACK PAIN ON PAIN, DISABILITY, QUALITY OF LIFE WITH NON-EXERCISE (E.G. USUAL CARE, EDUCATION), PHYSICAL THERAPY EXERCISE. METHODS: THIS STUDY WAS REGISTERED IN PROSPERO, AND THE REGISTRATION NUMBER WAS CRD42020159865. RANDOMIZED CONTROLLED TRIALS (RCTS) OF ONLINE DATABASES INCLUDED PUBMED, WEB OF SCIENCE, COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS, EMBASE WHICH EVALUATED EFFECTS OF YOGA FOR PATIENTS WITH CHRONIC LOW BACK PAIN ON PAIN, DISABILITY, AND QUALITY OF LIFE WERE SEARCHED FROM INCEPTION TIME TO NOVEMBER 1, 2019. STUDIES WERE ELIGIBLE IF THEY ASSESSED AT LEAST ONE IMPORTANT OUTCOME, NAMELY PAIN, BACK-SPECIFIC DISABILITY, QUALITY OF LIFE. THE COCHRANE RISK OF BIAS TOOL WAS USED TO ASSESS THE METHODOLOGICAL QUALITY OF INCLUDED RANDOMIZED CONTROLLED TRIALS. THE CONTINUOUS OUTCOMES WERE ANALYZED BY CALCULATING THE MEAN DIFFERENCE (MD) OR STANDARDIZED MEAN DIFFERENCE (SMD) WITH 95% CONFIDENCE INTERVALS (CI) ACCORDING TO WHETHER COMBINING OUTCOMES MEASURED ON DIFFERENT SCALES OR NOT. RESULTS: A TOTAL OF 18 RANDOMIZED CONTROLLED TRIALS WERE INCLUDED IN THIS META-ANALYSIS. YOGA COULD SIGNIFICANTLY REDUCE PAIN AT 4 TO 8 WEEKS (MD = -0.83, 95% CI = -1.19 TO -0.48, P<0.00001, I2 = 0%), 3 MONTHS (MD = -0.43, 95% CI = -0.64 TO -0.23, P<0.0001, I2 = 0%), 6 TO 7 MONTHS (MD = -0.56, 95% CI = -1.02 TO -0.11, P = 0.02, I2 = 50%), AND WAS NOT SIGNIFICANT IN 12 MONTHS (MD = -0.52, 95% CI = -1.64 TO 0.59, P = 0.36, I2 = 87%) COMPARED WITH NON-EXERCISE. YOGA WAS BETTER THAN NON-EXERCISE ON DISABILITY AT 4 TO 8 WEEKS (SMD = -0.30, 95% CI = -0.51 TO -0.10, P = 0.003, I2 = 0%), 3 MONTHS (SMD = -0.31, 95% CI = -0.45 TO -0.18, P<0.00001, I2 = 30%), 6 MONTHS (SMD = -0.38, 95% CI = -0.53 TO -0.23, P<0.00001, I2 = 0%), 12 MONTHS (SMD = -0.33, 95% CI = -0.54 TO -0.12, P = 0.002, I2 = 9%). THERE WAS NO SIGNIFICANT DIFFERENCE ON PAIN, DISABILITY COMPARED WITH PHYSICAL THERAPY EXERCISE GROUP. FURTHERMORE, IT SUGGESTED THAT THERE WAS A NON-SIGNIFICANT DIFFERENCE ON PHYSICAL AND MENTAL QUALITY OF LIFE BETWEEN YOGA AND ANY OTHER INTERVENTIONS. CONCLUSION: THIS META-ANALYSIS PROVIDED EVIDENCE FROM VERY LOW TO MODERATE INVESTIGATING THE EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN PATIENTS AT DIFFERENT TIME POINTS. YOGA MIGHT DECREASE PAIN FROM SHORT TERM TO INTERMEDIATE TERM AND IMPROVE FUNCTIONAL DISABILITY STATUS FROM SHORT TERM TO LONG TERM COMPARED WITH NON-EXERCISE (E.G. USUAL CARE, EDUCATION). YOGA HAD THE SAME EFFECT ON PAIN AND DISABILITY AS ANY OTHER EXERCISE OR PHYSICAL THERAPY. YOGA MIGHT NOT IMPROVE THE PHYSICAL AND MENTAL QUALITY OF LIFE BASED ON THE RESULT OF A MERGING. 2020 6 2821 62 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. BACKGROUND: NON-SPECIFIC LOW BACK PAIN IS A COMMON, POTENTIALLY DISABLING CONDITION USUALLY TREATED WITH SELF-CARE AND NON-PRESCRIPTION MEDICATION. FOR CHRONIC LOW BACK PAIN, CURRENT GUIDELINES STATE THAT EXERCISE THERAPY MAY BE BENEFICIAL. YOGA IS A MIND-BODY EXERCISE SOMETIMES USED FOR NON-SPECIFIC LOW BACK PAIN. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING CHRONIC NON-SPECIFIC LOW BACK PAIN, COMPARED TO NO SPECIFIC TREATMENT, A MINIMAL INTERVENTION (E.G. EDUCATION), OR ANOTHER ACTIVE TREATMENT, WITH A FOCUS ON PAIN, FUNCTION, AND ADVERSE EVENTS. SEARCH METHODS: WE SEARCHED CENTRAL, MEDLINE, EMBASE, FIVE OTHER DATABASES AND FOUR TRIALS REGISTERS TO 11 MARCH 2016 WITHOUT RESTRICTION OF LANGUAGE OR PUBLICATION STATUS. WE SCREENED REFERENCE LISTS AND CONTACTED EXPERTS IN THE FIELD TO IDENTIFY ADDITIONAL STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMIZED CONTROLLED TRIALS OF YOGA TREATMENT IN PEOPLE WITH CHRONIC NON-SPECIFIC LOW BACK PAIN. WE INCLUDED STUDIES COMPARING YOGA TO ANY OTHER INTERVENTION OR TO NO INTERVENTION. WE ALSO INCLUDED STUDIES COMPARING YOGA AS AN ADJUNCT TO OTHER THERAPIES, VERSUS THOSE OTHER THERAPIES ALONE. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SCREENED AND SELECTED STUDIES, EXTRACTED OUTCOME DATA, AND ASSESSED RISK OF BIAS. WE CONTACTED STUDY AUTHORS TO OBTAIN MISSING OR UNCLEAR INFORMATION. WE EVALUATED THE OVERALL CERTAINTY OF EVIDENCE USING THE GRADE APPROACH. MAIN RESULTS: WE INCLUDED 12 TRIALS (1080 PARTICIPANTS) CARRIED OUT IN THE USA (SEVEN TRIALS), INDIA (THREE TRIALS), AND THE UK (TWO TRIALS). STUDIES WERE UNFUNDED (ONE TRIAL), FUNDED BY A YOGA INSTITUTION (ONE TRIAL), FUNDED BY NON-PROFIT OR GOVERNMENT SOURCES (SEVEN TRIALS), OR DID NOT REPORT ON FUNDING (THREE TRIALS). MOST TRIALS USED IYENGAR, HATHA, OR VINIYOGA FORMS OF YOGA. THE TRIALS COMPARED YOGA TO NO INTERVENTION OR A NON-EXERCISE INTERVENTION SUCH AS EDUCATION (SEVEN TRIALS), AN EXERCISE INTERVENTION (THREE TRIALS), OR BOTH EXERCISE AND NON-EXERCISE INTERVENTIONS (TWO TRIALS). ALL TRIALS WERE AT HIGH RISK OF PERFORMANCE AND DETECTION BIAS BECAUSE PARTICIPANTS AND PROVIDERS WERE NOT BLINDED TO TREATMENT ASSIGNMENT, AND OUTCOMES WERE SELF-ASSESSED. THEREFORE, WE DOWNGRADED ALL OUTCOMES TO 'MODERATE' CERTAINTY EVIDENCE BECAUSE OF RISK OF BIAS, AND WHEN THERE WAS ADDITIONAL SERIOUS RISK OF BIAS, UNEXPLAINED HETEROGENEITY BETWEEN STUDIES, OR THE ANALYSES WERE IMPRECISE, WE DOWNGRADED THE CERTAINTY OF THE EVIDENCE FURTHER.FOR YOGA COMPARED TO NON-EXERCISE CONTROLS (9 TRIALS; 810 PARTICIPANTS), THERE WAS LOW-CERTAINTY EVIDENCE THAT YOGA PRODUCED SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE TO FOUR MONTHS (STANDARDIZED MEAN DIFFERENCE (SMD) -0.40, 95% CONFIDENCE INTERVAL (CI) -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) -2.18, 95% -3.60 TO -0.76), MODERATE-CERTAINTY EVIDENCE FOR SMALL TO MODERATE IMPROVEMENTS AT SIX MONTHS (SMD -0.44, 95% CI -0.66 TO -0.22; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -2.15, 95% -3.23 TO -1.08), AND LOW-CERTAINTY EVIDENCE FOR SMALL IMPROVEMENTS AT 12 MONTHS (SMD -0.26, 95% CI -0.46 TO -0.05; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -1.36, 95% -2.41 TO -0.26). ON A 0-100 SCALE THERE WAS VERY LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA WAS SLIGHTLY BETTER FOR PAIN AT THREE TO FOUR MONTHS (MD -4.55, 95% CI -7.04 TO -2.06), SIX MONTHS (MD -7.81, 95% CI -13.37 TO -2.25), AND 12 MONTHS (MD -5.40, 95% CI -14.50 TO -3.70), HOWEVER WE PRE-DEFINED CLINICALLY SIGNIFICANT CHANGES IN PAIN AS 15 POINTS OR GREATER AND THIS THRESHOLD WAS NOT MET. BASED ON INFORMATION FROM SIX TRIALS, THERE WAS MODERATE-CERTAINTY EVIDENCE THAT THE RISK OF ADVERSE EVENTS, PRIMARILY INCREASED BACK PAIN, WAS HIGHER IN YOGA THAN IN NON-EXERCISE CONTROLS (RISK DIFFERENCE (RD) 5%, 95% CI 2% TO 8%).FOR YOGA COMPARED TO NON-YOGA EXERCISE CONTROLS (4 TRIALS; 394 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE IN BACK-RELATED FUNCTION AT THREE MONTHS (SMD -0.22, 95% CI -0.65 TO 0.20; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.99, 95% -2.87 TO 0.90) AND SIX MONTHS (SMD -0.20, 95% CI -0.59 TO 0.19; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.90, 95% -2.61 TO 0.81), AND NO INFORMATION ON BACK-RELATED FUNCTION AFTER SIX MONTHS. THERE WAS VERY LOW-CERTAINTY EVIDENCE FOR LOWER PAIN ON A 0-100 SCALE AT SEVEN MONTHS (MD -20.40, 95% CI -25.48 TO -15.32), AND NO INFORMATION ON PAIN AT THREE MONTHS OR AFTER SEVEN MONTHS. BASED ON INFORMATION FROM THREE TRIALS, THERE WAS LOW-CERTAINTY EVIDENCE FOR NO DIFFERENCE IN THE RISK OF ADVERSE EVENTS BETWEEN YOGA AND NON-YOGA EXERCISE CONTROLS (RD 1%, 95% CI -4% TO 6%).FOR YOGA ADDED TO EXERCISE COMPARED TO EXERCISE ALONE (1 TRIAL; 24 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE AT 10 WEEKS IN BACK-RELATED FUNCTION (SMD -0.60, 95% CI -1.42 TO 0.22; CORRESPONDING TO A CHANGE IN THE OSWESTRY DISABILITY INDEX OF MD -17.05, 95% -22.96 TO 11.14) OR PAIN ON A 0-100 SCALE (MD -3.20, 95% CI -13.76 TO 7.36). THERE WAS NO INFORMATION ON OUTCOMES AT OTHER TIME POINTS. THERE WAS NO INFORMATION ON ADVERSE EVENTS.STUDIES PROVIDED LIMITED EVIDENCE ON RISK OF CLINICAL IMPROVEMENT, MEASURES OF QUALITY OF LIFE, AND DEPRESSION. THERE WAS NO EVIDENCE ON WORK-RELATED DISABILITY. AUTHORS' CONCLUSIONS: THERE IS LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA COMPARED TO NON-EXERCISE CONTROLS RESULTS IN SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE AND SIX MONTHS. YOGA MAY ALSO BE SLIGHTLY MORE EFFECTIVE FOR PAIN AT THREE AND SIX MONTHS, HOWEVER THE EFFECT SIZE DID NOT MEET PREDEFINED LEVELS OF MINIMUM CLINICAL IMPORTANCE. IT IS UNCERTAIN WHETHER THERE IS ANY DIFFERENCE BETWEEN YOGA AND OTHER EXERCISE FOR BACK-RELATED FUNCTION OR PAIN, OR WHETHER YOGA ADDED TO EXERCISE IS MORE EFFECTIVE THAN EXERCISE ALONE. YOGA IS ASSOCIATED WITH MORE ADVERSE EVENTS THAN NON-EXERCISE CONTROLS, BUT MAY HAVE THE SAME RISK OF ADVERSE EVENTS AS OTHER BACK-FOCUSED EXERCISE. YOGA IS NOT ASSOCIATED WITH SERIOUS ADVERSE EVENTS. THERE IS A NEED FOR ADDITIONAL HIGH-QUALITY RESEARCH TO IMPROVE CONFIDENCE IN ESTIMATES OF EFFECT, TO EVALUATE LONG-TERM OUTCOMES, AND TO PROVIDE ADDITIONAL INFORMATION ON COMPARISONS BETWEEN YOGA AND OTHER EXERCISE FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. 2017 7 945 48 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P 3-POINT REDUCTION IN PSQI) AT 12 WEEKS VARIED BY CHANGES IN PAIN AND PHYSICAL FUNCTION AT 6 WEEKS. KEY RESULTS: AMONG PARTICIPANTS (MEAN AGE = 46.0, 64% FEMALE, 82% NON-WHITE), NEARLY ALL (92%) REPORTED POOR SLEEP QUALITY (PSQI > 5) AT BASELINE. AT 12 WEEKS, MODEST IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED AMONG THE YOGA (PSQI MEAN DIFFERENCE [MD] = - 1.19, 95% CONFIDENCE INTERVAL [CI] - 1.82, - 0.55) AND PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) GROUPS. PARTICIPANTS WHO REPORTED A >/= 30% IMPROVEMENT IN PAIN OR PHYSICAL FUNCTION AT 6 WEEKS, COMPARED WITH THOSE WHO IMPROVED < 10%, WERE MORE LIKELY TO BE A SLEEP QUALITY RESPONDER AT 12 WEEKS (ODDS RATIO [OR] = 3.51, 95% CI 1.73, 7.11 AND OR = 2.16, 95% CI 1.18, 3.95, RESPECTIVELY). RESULTS WERE SIMILAR AT 52 WEEKS. CONCLUSION: IN A SAMPLE OF ADULTS WITH CLBP, VIRTUALLY ALL WITH POOR SLEEP QUALITY PRIOR TO INTERVENTION, MODEST BUT STATISTICALLY SIGNIFICANT IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED WITH BOTH YOGA AND PT. IRRESPECTIVE OF TREATMENT, CLINICALLY IMPORTANT SLEEP IMPROVEMENTS AT THE END OF THE INTERVENTION WERE ASSOCIATED WITH MID-INTERVENTION PAIN AND PHYSICAL FUNCTION IMPROVEMENTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01343927. 2020 9 521 58 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS. 2005 10 193 56 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011 11 2596 56 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158. 2017 12 1787 52 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH. 2015 13 2560 50 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK. 2011 14 162 49 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 15 2820 60 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN (2017). WIELAND LS, SKOETZ N, PILKINGTON K, VEMPATI R, DADAMO CR, BERMAN BM. YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN.COCHRANE DATABASE SYST REV2017, ISSUE 1. ART. NO.: CD010671. DOI: 10.1002/14651858.CD010671.PUB2. BACKGROUND: NON-SPECIFIC LOW BACK PAIN IS A COMMON, POTENTIALLY DISABLING CONDITION USUALLY TREATED WITH SELF-CARE AND NON-PRESCRIPTION MEDICATION. FOR CHRONIC LOW BACK PAIN, CURRENT GUIDELINES STATE THAT EXERCISE THERAPY MAY BE BENEFICIAL. YOGA IS A MIND-BODY EXERCISE SOMETIMES USED FOR NON-SPECIFIC LOW BACK PAIN. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING CHRONIC NON-SPECIFIC LOW BACK PAIN, COMPARED TO NO SPECIFIC TREATMENT, A MINIMAL INTERVENTION (E.G., EDUCATION), OR ANOTHER ACTIVE TREATMENT, WITH A FOCUS ON PAIN, FUNCTION, AND ADVERSE EVENTS. SEARCH METHODS: WE SEARCHED CENTRAL, MEDLINE, EMBASE, FIVE OTHER DATABASES, AND FOUR TRIALS REGISTERS TO 11 MARCH 2016 WITHOUT RESTRICTION OF LANGUAGE OR PUBLICATION STATUS. WE SCREENED REFERENCE LISTS AND CONTACTED EXPERTS IN THE FIELD TO IDENTIFY ADDITIONAL STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMIZED CONTROLLED TRIALS OF YOGA TREATMENT IN PEOPLE WITH CHRONIC NON-SPECIFIC LOW BACK PAIN. WE INCLUDED STUDIES COMPARING YOGA TO ANY OTHER INTERVENTION OR TO NO INTERVENTION. WE ALSO INCLUDED STUDIES COMPARING YOGA AS AN ADJUNCT TO OTHER THERAPIES, VERSUS THOSE OTHER THERAPIES ALONE. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SCREENED AND SELECTED STUDIES, EXTRACTED OUTCOME DATA, AND ASSESSED RISK OF BIAS. WE CONTACTED STUDY AUTHORS TO OBTAIN MISSING OR UNCLEAR INFORMATION. WE EVALUATED THE OVERALL CERTAINTY OF EVIDENCE USING THE GRADE APPROACH. MAIN RESULTS: WE INCLUDED 12 TRIALS (1080 PARTICIPANTS) CARRIED OUT IN THE USA (SEVEN TRIALS), INDIA (THREE TRIALS), AND THE UK (TWO TRIALS). STUDIES WERE UNFUNDED (ONE TRIAL), FUNDED BY A YOGA INSTITUTION (ONE TRIAL), FUNDED BY NON-PROFIT OR GOVERNMENT SOURCES (SEVEN TRIALS), OR DID NOT REPORT ON FUNDING (THREE TRIALS). MOST TRIALS USED IYENGAR, HATHA, OR VINIYOGA FORMS OF YOGA. THE TRIALS COMPARED YOGA TO NO INTERVENTION OR A NON-EXERCISE INTERVENTION SUCH AS EDUCATION (SEVEN TRIALS), AN EXERCISE INTERVENTION (THREE TRIALS), OR BOTH EXERCISE AND NON-EXERCISE INTERVENTIONS (TWO TRIALS). ALL TRIALS WERE AT HIGH RISK OF PERFORMANCE AND DETECTION BIAS BECAUSE PARTICIPANTS AND PROVIDERS WERE NOT BLINDED TO TREATMENT ASSIGNMENT, AND OUTCOMES WERE SELF-ASSESSED. THEREFORE, WE DOWNGRADED ALL OUTCOMES TO "MODERATE" CERTAINTY EVIDENCE BECAUSE OF RISK OF BIAS, AND WHEN THERE WAS ADDITIONAL SERIOUS RISK OF BIAS, UNEXPLAINED HETEROGENEITY BETWEEN STUDIES, OR THE ANALYSES WERE IMPRECISE, WE DOWNGRADED THE CERTAINTY OF THE EVIDENCE FURTHER. FOR YOGA COMPARED TO NON-EXERCISE CONTROLS (9 TRIALS; 810 PARTICIPANTS), THERE WAS LOW-CERTAINTY EVIDENCE THAT YOGA PRODUCED SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE TO FOUR MONTHS [STANDARDIZED MEAN DIFFERENCE (SMD) = -0.40, 95% CI: -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) = -2.18, 95% CI: -3.60 TO -0.76], MODERATE-CERTAINTY EVIDENCE FOR SMALL TO MODERATE IMPROVEMENTS AT SIX MONTHS (SMD = -0.44, 95% CI: -0.66 TO -0.22; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -2.15, 95% CI: -3.23 TO -1.08), AND LOW-CERTAINTY EVIDENCE FOR SMALL IMPROVEMENTS AT 12 MONTHS (SMD = -0.26, 95% CI: -0.46 TO -0.05; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -1.36, 95% CI: -2.41 TO -0.26). ON A 0-100 SCALE THERE WAS VERY LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA WAS SLIGHTLY BETTER FOR PAIN AT THREE TO FOUR MONTHS (MD = -4.55, 95% CI: -7.04 TO -2.06), SIX MONTHS (MD = -7.81, 95% CI: -13.37 TO -2.25), AND 12 MONTHS (MD = -5.40, 95% CI: -14.50 TO -3.70); HOWEVER, WE PRE-DEFINED CLINICALLY SIGNIFICANT CHANGES IN PAIN AS 15 POINTS OR GREATER AND THIS THRESHOLD WAS NOT MET. BASED ON INFORMATION FROM SIX TRIALS, THERE WAS MODERATE-CERTAINTY EVIDENCE THAT THE RISK OF ADVERSE EVENTS, PRIMARILY INCREASED BACK PAIN, WAS HIGHER IN YOGA THAN IN NON-EXERCISE CONTROLS [RISK DIFFERENCE (RD) = 5%, 95% CI: 2-8%]. FOR YOGA COMPARED TO NON-YOGA EXERCISE CONTROLS (4 TRIALS; 394 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE IN BACK-RELATED FUNCTION AT THREE MONTHS (SMD = -0.22, 95% CI: -0.65 TO 0.20; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -0.99, 95% CI: -2.87 TO 0.90) AND SIX MONTHS (SMD = -0.20, 95% CI: -0.59 TO 0.19; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD = -0.90, 95% CI: -2.61 TO 0.81), AND NO INFORMATION ON BACK-RELATED FUNCTION AFTER SIX MONTHS. THERE WAS VERY LOW-CERTAINTY EVIDENCE FOR LOWER PAIN ON A 0-100 SCALE AT SEVEN MONTHS (MD = -20.40, 95% CI: -25.48 TO -15.32), AND NO INFORMATION ON PAIN AT THREE MONTHS OR AFTER SEVEN MONTHS. BASED ON INFORMATION FROM THREE TRIALS, THERE WAS LOW-CERTAINTY EVIDENCE FOR NO DIFFERENCE IN THE RISK OF ADVERSE EVENTS BETWEEN YOGA AND NON-YOGA EXERCISE CONTROLS (RD = 1%, 95% CI: -4% TO 6%). FOR YOGA ADDED TO EXERCISE COMPARED TO EXERCISE ALONE (1 TRIAL; 24 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE AT 10 WEEKS IN BACK-RELATED FUNCTION (SMD = -0.60, 95% CI: -1.42 TO 0.22; CORRESPONDING TO A CHANGE IN THE OSWESTRY DISABILITY INDEX OF MD = -17.05, 95% CI: -22.96 TO 11.14) OR PAIN ON A 0-100 SCALE (MD = -3.20, 95% CI: -13.76 TO 7.36). THERE WAS NO INFORMATION ON OUTCOMES AT OTHER TIME POINTS. THERE WAS NO INFORMATION ON ADVERSE EVENTS. STUDIES PROVIDED LIMITED EVIDENCE ON RISK OF CLINICAL IMPROVEMENT, MEASURES OF QUALITY OF LIFE, AND DEPRESSION. THERE WAS NO EVIDENCE ON WORK-RELATED DISABILITY. 2017 16 2843 26 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS. 2021 17 74 43 A GROUP-BASED YOGA THERAPY INTERVENTION FOR URINARY INCONTINENCE IN WOMEN: A PILOT RANDOMIZED TRIAL. OBJECTIVE: THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION FOR MIDDLE-AGED AND OLDER WOMEN WITH URINARY INCONTINENCE. METHODS: WE CONDUCTED A PILOT RANDOMIZED TRIAL OF AMBULATORY WOMEN AGED 40 YEARS AND OLDER WITH STRESS, URGENCY, OR MIXED-TYPE INCONTINENCE. WOMEN WERE RANDOMIZED TO A 6-WEEK YOGA THERAPY PROGRAM (N = 10) CONSISTING OF TWICE WEEKLY GROUP CLASSES AND ONCE WEEKLY HOME PRACTICE OR A WAIT-LIST CONTROL GROUP (N = 9). ALL PARTICIPANTS ALSO RECEIVED WRITTEN PAMPHLETS ABOUT STANDARD BEHAVIORAL SELF-MANAGEMENT STRATEGIES FOR INCONTINENCE. CHANGES IN INCONTINENCE WERE ASSESSED WITH 7-DAY VOIDING DIARIES. RESULTS: THE MEAN (SD) AGE WAS 61.4 (8.2) YEARS, AND THE MEAN BASELINE FREQUENCY OF INCONTINENCE WAS 2.5 (1.3) EPISODES/D. AFTER 6 WEEKS, THE TOTAL INCONTINENCE FREQUENCY DECREASED BY 70% (1.8 [0.9] FEWER EPISODES/D) IN THE YOGA THERAPY VERSUS 13% (0.3 [1.7] FEWER EPISODES/D) IN THE CONTROL GROUP (P = 0.049). PARTICIPANTS IN THE YOGA THERAPY GROUP ALSO REPORTED AN AVERAGE OF 71% DECREASE IN STRESS INCONTINENCE FREQUENCY (0.7 [0.8] FEWER EPISODES/D) COMPARED WITH A 25% INCREASE IN CONTROLS (0.2 [1.1] MORE EPISODES/D) (P = 0.039). NO SIGNIFICANT DIFFERENCES IN REDUCTION IN URGENCY INCONTINENCE WERE DETECTED BETWEEN THE YOGA THERAPY VERSUS CONTROL GROUPS (1.0 [1.0] VERSUS 0.5 [0.5] FEWER EPISODES/D; P = 0.20). ALL WOMEN STARTING THE YOGA THERAPY PROGRAM COMPLETED AT LEAST 90% OF THE GROUP CLASSES AND PRACTICE SESSIONS. TWO PARTICIPANTS IN EACH GROUP REPORTED ADVERSE EVENTS UNRELATED TO THE INTERVENTION. CONCLUSIONS: FINDINGS PROVIDE PRELIMINARY EVIDENCE TO SUPPORT THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION TO IMPROVE URINARY INCONTINENCE IN WOMEN. 2014 18 2829 47 YOGA VERSUS STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA TO DETERMINE ITS EFFICACY AS AN ADJUNCT TO STANDARD-CARE TREATMENT. OBJECTIVES: TO EXAMINE THE EFFECTS OF YOGA VERSUS STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: WE SEARCHED THE COCHRANE SCHIZOPHRENIA GROUP TRIALS REGISTER (NOVEMBER 2012 AND JANUARY 29, 2015), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE WERE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA COMPARING YOGA TO STANDARD-CARE CONTROL. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, QUALITY RATED THESE, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED MIXED-EFFECT AND FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED 'SUMMARY OF FINDINGS' TABLES USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE INCLUDED EIGHT STUDIES IN THE REVIEW. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WERE CLEAR DIFFERENCES IN A NUMBER OF OUTCOMES IN FAVOUR OF THE YOGA GROUP, ALTHOUGH THESE WERE BASED ON ONE STUDY EACH, WITH THE EXCEPTION OF LEAVING THE STUDY EARLY. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N = 83, RR 0.70 CI 0.55 TO 0.88, MEDIUM-QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N = 83, RR 0.88 CI 0.77 TO 1, MEDIUM-QUALITY EVIDENCE), QUALITY OF LIFE (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUBSCALE, 1 RCT, N = 60, MD 15.50, 95% CI 4.27 TO 26.73, LOW-QUALITY EVIDENCE), AND LEAVING THE STUDY EARLY (8 RCTS, N = 457, RR 0.91 CI 0.6 TO 1.37, MEDIUM-QUALITY EVIDENCE). FOR THE OUTCOME OF PHYSICAL HEALTH, THERE WAS NOT A CLEAR DIFFERENCE BETWEEN GROUPS (AVERAGE CHANGE SF-36 PHYSICAL-HEALTH SUBSCALE, 1 RCT, N = 60, MD 6.60, 95% CI -2.44 TO 15.64, LOW-QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THIS REVIEW WAS SUBJECT TO A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED GLOBAL STATE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: EVEN THOUGH WE FOUND SOME POSITIVE EVIDENCE IN FAVOUR OF YOGA OVER STANDARD-CARE CONTROL, THIS SHOULD BE INTERPRETED CAUTIOUSLY IN VIEW OF OUTCOMES LARGELY BASED EACH ON ONE STUDY WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - -TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR TO STANDARD-CARE CONTROL FOR THE MANAGEMENT OF SCHIZOPHRENIA. 2015 19 2558 60 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE. 2009 20 1165 51 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818. 2019