1 540 206 COMPLIANCE EFFECTS IN A RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: A METHODOLOGICAL STUDY. STUDY DESIGN: METHODOLOGICAL STUDY NESTED WITHIN A MULTICENTRE RANDOMISED CONTROLLED TRIAL (RCT) OF YOGA PLUS USUAL GENERAL PRACTITIONER (GP) CARE VS USUAL GP CARE FOR CHRONIC LOW BACK PAIN. OBJECTIVE: TO EXPLORE THE TREATMENT EFFECTS OF NON-COMPLIANCE USING THREE APPROACHES IN AN RCT EVALUATING YOGA FOR LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: A LARGE MULTICENTRE RCT USING INTENTION-TO-TREAT (ITT) ANALYSIS FOUND THAT PARTICIPANTS WITH CHRONIC LOW BACK PAIN WHO WERE OFFERED A 12-WEEK PROGRESSIVE PROGRAMME OF YOGA PLUS USUAL GP CARE HAD BETTER BACK FUNCTION THAN THOSE OFFERED USUAL GP CARE ALONE. HOWEVER, ITT ANALYSIS CAN UNDERESTIMATE THE EFFECT OF TREATMENT IN THOSE WHO COMPLY WITH TREATMENT. AS SUCH, THE DATA WERE ANALYSED USING OTHER APPROACHES TO ASSESS THE PROBLEM OF NON-COMPLIANCE. THE MAIN OUTCOME MEASURE WAS THE SELF-REPORTED ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ). METHODS: COMPLIER AVERAGE CAUSAL EFFECT (CACE) ANALYSIS, PER-PROTOCOL ANALYSIS AND ON-TREATMENT ANALYSIS WERE CONDUCTED ON THE DATA OF PARTICIPANTS WHO WERE FULLY COMPLIANT, PREDEFINED AS ATTENDANCE OF AT LEAST THREE OF THE FIRST SIX SESSIONS AND AT LEAST THREE OTHER SESSIONS. THE ANALYSIS WAS REPEATED FOR PARTICIPANTS WHO HAD ATTENDED AT LEAST ONE YOGA SESSION (I.E. ANY COMPLIANCE), WHICH INCLUDED PARTICIPANTS WHO WERE FULLY COMPLIANT. EACH APPROACH WAS DESCRIBED, INCLUDING STRENGTHS AND WEAKNESSES, AND THE RESULTS OF THE DIFFERENT APPROACHES WERE COMPARED WITH THOSE OF THE ITT ANALYSIS. RESULTS: FOR THE PARTICIPANTS WHO WERE FULLY COMPLIANT (N=93, 60%), A LARGER BENEFICIAL TREATMENT EFFECT WAS SEEN USING CACE ANALYSIS COMPARED WITH PER-PROTOCOL, ON-TREATMENT AND ITT ANALYSES AT 3 AND 12 MONTHS. THE DIFFERENCE IN MEAN CHANGE IN RMDQ SCORE BETWEEN RANDOMISED GROUPS WAS -3.30 [95% CONFIDENCE INTERVAL (CI) -4.90 TO -1.70, P<0.001] AT 3 MONTHS AND -2.23 (95% CI -3.93 TO -0.53, P=0.010) AT 12 MONTHS FOR CACE ANALYSIS, -3.12 (95% CI -4.26 TO -1.98, P<0.001) AT 3 MONTHS AND -2.11 (95% CI -3.33 TO -0.89, P=0.001) AT 12 MONTHS FOR PER-PROTOCOL ANALYSIS, AND -2.91 (95% CI -4.06 TO -1.76, P<0.001) AT 3 MONTHS AND -2.10 (95% CI -3.31 TO -0.89, P=0.001) AT 12 MONTHS FOR ON-TREATMENT ANALYSIS. FOR THE PARTICIPANTS WHO DEMONSTRATED ANY COMPLIANCE (N=133, 85%), THE RESULTS WERE GENERALLY CONSISTENT WITH THE FULLY COMPLIANT GROUP AT 3 MONTHS, BUT THE TREATMENT EFFECT WAS SMALLER. THE DIFFERENCE IN MEAN CHANGE IN RMDQ SCORE BETWEEN RANDOMISED GROUPS WAS -2.45 (95% CI -3.67 TO -1.24) FOR CACE ANALYSIS, -2.30 (95% CI -3.43 TO 1.17) FOR PER-PROTOCOL ANALYSIS AND -2.15 (95% CI -3.25 TO -1.06) FOR ON-TREATMENT ANALYSIS, WHICH WAS SLIGHTLY LESS THAN THAT FOR ITT ANALYSIS. IN CONTRAST, AT 12 MONTHS, PER-PROTOCOL AND ON-TREATMENT ANALYSES SHOWED A LARGER TREATMENT EFFECT COMPARED WITH CACE AND ITT ANALYSES: PER PROTOCOL ANALYSIS -1.86 (95% CI -3.02 TO -0.71), ON-TREATMENT ANALYSIS -1.99 (95% CI -3.13 TO -0.86) AND CACE ANALYSIS -1.67 (95% CI -2.95 TO -0.40). CONCLUSION: ITT ANALYSIS ESTIMATED A SLIGHTLY SMALLER TREATMENT EFFECT IN PARTICIPANTS WHO COMPLIED WITH TREATMENT. WHEN EXAMINING COMPLIANCE, CACE ANALYSIS IS MORE RIGOROUS THAN PER-PROTOCOL AND ON-TREATMENT ANALYSES. USING CACE ANALYSIS, THE TREATMENT EFFECT WAS LARGER IN PARTICIPANTS WHO COMPLIED WITH TREATMENT COMPARED WITH PARTICIPANTS WHO WERE ALLOCATED TO TREATMENT, AND THE DIFFERENCE BETWEEN ITT AND CACE ANALYSES FOR THE FULLY COMPLIANT GROUP AT 3 MONTHS WAS SMALL BUT CLINICALLY IMPORTANT. PER-PROTOCOL AND ON-TREATMENT ANALYSES MAY PRODUCE UNRELIABLE ESTIMATES WHEN THE EFFECT OF TREATMENT IS SMALL. INTERNATIONAL STANDARD RANDOMISED TRIAL NUMBER REGISTER: ISRCTN 81079604. 2014 2 2560 72 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 3 162 62 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 4 193 49 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 5 1180 54 EVALUATION OF THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. STUDY DESIGN: THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA FOR CHRONIC LOW BACK PAIN (CLBP) WERE ASSESSED WITH INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSIS. NINETY SUBJECTS WERE RANDOMIZED TO A YOGA (N = 43) OR CONTROL GROUP (N = 47) RECEIVING STANDARD MEDICAL CARE. PARTICIPANTS WERE FOLLOWED 6 MONTHS AFTER COMPLETION OF THE INTERVENTION. OBJECTIVE: THIS STUDY AIMED TO EVALUATE IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. YOGA SUBJECTS WERE HYPOTHESIZED TO REPORT GREATER REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, DEPRESSION, AND PAIN MEDICATION USAGE THAN CONTROLS. SUMMARY OF BACKGROUND DATA: CLBP IS A MUSCULOSKELETAL DISORDER WITH PUBLIC HEALTH AND ECONOMIC IMPACT. PILOT STUDIES OF YOGA AND BACK PAIN HAVE REPORTED SIGNIFICANT CHANGES IN CLINICALLY IMPORTANT OUTCOMES. METHODS: SUBJECTS WERE RECRUITED THROUGH SELF-REFERRAL AND HEALTH PROFESSIONAL REFERRALS ACCORDING TO EXPLICIT INCLUSION/EXCLUSION CRITERIA. YOGA SUBJECTS PARTICIPATED IN 24 WEEKS OF BIWEEKLY YOGA CLASSES DESIGNED FOR CLBP. OUTCOMES WERE ASSESSED AT 12 (MIDWAY), 24 (IMMEDIATELY AFTER), AND 48 WEEKS (6-MONTH FOLLOW-UP) AFTER THE START OF THE INTERVENTION USING THE OSWESTRY DISABILITY QUESTIONNAIRE, A VISUAL ANALOG SCALE, THE BECK DEPRESSION INVENTORY, AND A PAIN MEDICATION-USAGE QUESTIONNAIRE. RESULTS: USING INTENTION-TO-TREAT ANALYSIS WITH REPEATED MEASURES ANOVA (GROUP X TIME), SIGNIFICANTLY GREATER REDUCTIONS IN FUNCTIONAL DISABILITY AND PAIN INTENSITY WERE OBSERVED IN THE YOGA GROUP WHEN COMPARED TO THE CONTROL GROUP AT 24 WEEKS. A SIGNIFICANTLY GREATER PROPORTION OF YOGA SUBJECTS ALSO REPORTED CLINICAL IMPROVEMENTS AT BOTH 12 AND 24 WEEKS. IN ADDITION, DEPRESSION WAS SIGNIFICANTLY LOWER IN YOGA SUBJECTS. FURTHERMORE, WHILE A REDUCTION IN PAIN MEDICATION OCCURRED, THIS WAS COMPARABLE IN BOTH GROUPS. WHEN RESULTS WERE ANALYZED USING PER-PROTOCOL ANALYSIS, IMPROVEMENTS WERE OBSERVED FOR ALL OUTCOMES IN THE YOGA GROUP, INCLUDING AGREATER TREND FOR REDUCED PAIN MEDICATION USAGE. ALTHOUGH SLIGHTLY LESS THAN AT 24 WEEKS, THE YOGA GROUP HAD STATISTICALLY SIGNIFICANT REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION COMPARED TO STANDARD MEDICAL CARE 6-MONTHS POSTINTERVENTION. CONCLUSION: YOGA IMPROVES FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION IN ADULTS WITH CLBP. THERE WAS ALSO A CLINICALLY IMPORTANT TREND FOR THE YOGA GROUP TO REDUCE THEIR PAIN MEDICATION USAGE COMPARED TO THE CONTROL GROUP. 2009 6 1841 42 QIGONG OR YOGA VERSUS NO INTERVENTION IN OLDER ADULTS WITH CHRONIC LOW BACK PAIN-A RANDOMIZED CONTROLLED TRIAL. UNLABELLED: THE AIM OF THIS STUDY WAS TO ASSESS THE EFFECTIVENESS OF THE REDUCTION OF CHRONIC LOWER BACK PAIN IN OLDER ADULTS USING EITHER YOGA CLASSES OR QIGONG CLASSES COMPARED WITH NO INTERVENTION. OLDER ADULTS (65 YEARS OF AGE AND OLDER) WITH CHRONIC LOW BACK PAIN WERE ENROLLED IN AND RANDOMLY ALLOCATED TO: 1) YOGA (24 CLASSES, 45 MINUTES EACH, DURING 3 MONTHS), 2) QIGONG (12 CLASSES, 90 MINUTES EACH, DURING 3 MONTHS), OR 3) A CONTROL GROUP WHO RECEIVED NO ADDITIONAL INTERVENTION. THE PAIN INTENSITY ITEM OF THE FUNCTIONAL RATING INDEX AFTER 3 MONTHS WAS USED AS PRIMARY OUTCOME PARAMETER. A TOTAL OF 176 PATIENTS WERE RANDOMIZED (N = 61 YOGA, N = 58 QIGONG, N = 57 CONTROL; MEAN AGE 73 +/- 5.6 YEARS, 89% FEMALE). THE MEAN ADJUSTED PAIN INTENSITY AFTER 3 MONTHS WAS 1.71 FOR THE YOGA GROUP (95% CONFIDENCE INTERVAL [CI], 1.54-1.89), 1.67 FOR THE QIGONG GROUP (95% CI, 1.45-1.89), AND 1.89 FOR NO INTERVENTION (95% CI, 1.67-2.11). NO STATISTICALLY SIGNIFICANT GROUP DIFFERENCES WERE OBSERVED. POSSIBLE EXPLANATIONS FOR THIS LACK OF PAIN RELIEF MIGHT INCLUDE THE INEFFECTIVENESS OF INTERVENTIONS, INAPPROPRIATE OUTCOMES, OR DIFFERENCES IN PAIN PERCEPTION AND PROCESSING IN OLDER ADULTS. PERSPECTIVE: THE AIM OF THIS STUDY WAS TO ASSESS THE EFFECTIVENESS OF THE REDUCTION OF CHRONIC LOWER BACK PAIN IN OLDER ADULTS USING EITHER YOGA CLASSES OR QIGONG CLASSES COMPARED WITH NO INTERVENTION. THIS 3-ARMED RANDOMIZED TRIAL WITH 176 OLDER ADULTS SHOWED THAT YOGA AND QIGONG WERE NOT SUPERIOR TO NO TREATMENT IN REDUCING PAIN AND INCREASING QUALITY OF LIFE. 2016 7 721 46 EFFECT OF IYENGAR YOGA THERAPY FOR CHRONIC LOW BACK PAIN. LOW BACK PAIN IS A SIGNIFICANT PUBLIC HEALTH PROBLEM AND ONE OF THE MOST COMMONLY REPORTED REASONS FOR THE USE OF COMPLEMENTARY ALTERNATIVE MEDICINE. A RANDOMIZED CONTROL TRIAL WAS CONDUCTED IN SUBJECTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN COMPARING IYENGAR YOGA THERAPY TO AN EDUCATIONAL CONTROL GROUP. BOTH PROGRAMS WERE 16 WEEKS LONG. SUBJECTS WERE PRIMARILY SELF-REFERRED AND SCREENED BY PRIMARY CARE PHYSICIANS FOR STUDY OF INCLUSION/EXCLUSION CRITERIA. THE PRIMARY OUTCOME FOR THE STUDY WAS FUNCTIONAL DISABILITY. SECONDARY OUTCOMES INCLUDING PRESENT PAIN INTENSITY, PAIN MEDICATION USAGE, PAIN-RELATED ATTITUDES AND BEHAVIORS, AND SPINAL RANGE OF MOTION WERE MEASURED BEFORE AND AFTER THE INTERVENTIONS. SUBJECTS HAD LOW BACK PAIN FOR 11.2+/-1.54 YEARS AND 48% USED PAIN MEDICATION. OVERALL, SUBJECTS PRESENTED WITH LESS PAIN AND LOWER FUNCTIONAL DISABILITY THAN SUBJECTS IN OTHER PUBLISHED INTERVENTION STUDIES FOR CHRONIC LOW BACK PAIN. OF THE 60 SUBJECTS ENROLLED, 42 (70%) COMPLETED THE STUDY. MULTIVARIATE ANALYSES OF OUTCOMES IN THE CATEGORIES OF MEDICAL, FUNCTIONAL, PSYCHOLOGICAL AND BEHAVIORAL FACTORS INDICATED THAT SIGNIFICANT DIFFERENCES BETWEEN GROUPS EXISTED IN FUNCTIONAL AND MEDICAL OUTCOMES BUT NOT FOR THE PSYCHOLOGICAL OR BEHAVIORAL OUTCOMES. UNIVARIATE ANALYSES OF MEDICAL AND FUNCTIONAL OUTCOMES REVEALED SIGNIFICANT REDUCTIONS IN PAIN INTENSITY (64%), FUNCTIONAL DISABILITY (77%) AND PAIN MEDICATION USAGE (88%) IN THE YOGA GROUP AT THE POST AND 3-MONTH FOLLOW-UP ASSESSMENTS. THESE PRELIMINARY DATA INDICATE THAT THE MAJORITY OF SELF-REFERRED PERSONS WITH MILD CHRONIC LOW BACK PAIN WILL COMPLY TO AND REPORT IMPROVEMENT ON MEDICAL AND FUNCTIONAL PAIN-RELATED OUTCOMES FROM IYENGAR YOGA THERAPY. 2005 8 2845 49 YOGA, EURYTHMY THERAPY AND STANDARD PHYSIOTHERAPY (YES-TRIAL) FOR PATIENTS WITH CHRONIC NON-SPECIFIC LOW BACK PAIN: A THREE-ARMED RANDOMIZED CONTROLLED TRIAL. WE AIMED TO EVALUATE THE EFFECTS OF YOGA AND EURYTHMY THERAPY COMPARED TO CONVENTIONAL PHYSIOTHERAPY EXERCISES IN PATIENTS WITH CHRONIC LOW BACK PAIN. IN A THREE-ARMED, MULTICENTRE, RANDOMIZED CONTROLLED TRIAL, PATIENTS WITH CHRONIC LOW BACK PAIN WERE TREATED FOR 8 WEEKS IN GROUP SESSIONS (75 MINUTES ONCE PER WEEK). PRIMARY OUTCOME WAS PATIENTS' PHYSICAL DISABILITY (MEASURED BY RMDQ) FROM BASELINE TO WEEK 8. SECONDARY OUTCOME VARIABLES WERE PAIN INTENSITY AND PAIN-RELATED BOTHERSOMENESS (VAS), HEALTH-RELATED QUALITY OF LIFE (SF-12) AND LIFE SATISFACTION (BMLSS). OUTCOMES WERE ASSESSED AT BASELINE, AFTER THE INTERVENTION AT 8 WEEKS AND AT A 16-WEEK FOLLOW UP. DATA OF 274 PARTICIPANTS WERE USED FOR STATISTICAL ANALYSES. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE THREE GROUPS FOR THE PRIMARY AND ALL SECONDARY OUTCOMES. IN ALL GROUPS, RMDQ DECREASED COMPARABLY AT 8 WEEKS, BUT DID NOT REACH CLINICAL MEANINGFULNESS. PAIN INTENSITY AND PAIN-RELATED BOTHERSOMENESS DECREASED, WHILE QUALITY OF LIFE INCREASED IN ALL 3 GROUPS. IN EXPLORATIVE GENERAL LINEAR MODELS FOR THE SF-12'S MENTAL HEALTH COMPONENT PARTICIPANTS IN THE EURYTHMY ARM BENEFITTED SIGNIFICANTLY MORE COMPARED TO PHYSIOTHERAPY AND YOGA. FURTHERMORE, WITHIN-GROUP ANALYSES SHOWED IMPROVEMENTS OF SF-12 MENTAL SCORE FOR YOGA AND EURYTHMY THERAPY ONLY. ALL INTERVENTIONS WERE SAFE. CLINICAL TRIALS REGISTER: DRKS-ID: DRKS00004651 PERSPECTIVE: THIS ARTICLE PRESENTS THE RESULTS OF A MULTICENTRE THREE-ARMED RANDOMIZED CONTROLLED TRIAL ON THE CLINICAL EFFECTS OF THREE 8-WEEK PROGRAMS IN PATIENTS WITH CHRONIC LOW BACK PAIN. COMPARED TO THE 'GOLD STANDARD' OF CONVENTIONAL PHYSIOTHERAPEUTIC EXERCISES, EURYTHMY THERAPY AND YOGA THERAPY LEAD TO COMPARABLE SYMPTOMATIC IMPROVEMENTS IN PATIENTS WITH CHRONIC LOW BACK PAIN. HOWEVER, THE WITHIN-GROUP EFFECT SIZES WERE SMALL TO MODERATE AND DID NOT REACH CLINICAL MEANINGFULNESS ON PATIENTS' PHYSICAL DISABILITY (RMDQ). 2021 9 2811 43 YOGA TO PREVENT MOBILITY LIMITATIONS IN OLDER ADULTS: FEASIBILITY OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: THE LOSS OF MOBILITY DURING AGING IMPACTS INDEPENDENCE AND LEADS TO FURTHER DISABILITY, MORBIDITY, AND REDUCED LIFE EXPECTANCY. OUR OBJECTIVE WAS TO EXAMINE THE FEASIBILITY AND SAFETY OF CONDUCTING A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR OLDER ADULTS AT RISK FOR MOBILITY LIMITATIONS. METHODS: SEDENTARY OLDER ADULTS (N = 46; AGE 60-89) WERE RECRUITED AND RANDOMIZED TO EITHER YOGA OR A HEALTH EDUCATION COMPARISON GROUP. YOGA SESSIONS (60-MIN) OCCURRED 2X WEEKLY, AND 90-MIN HEALTH EDUCATION SESSIONS OCCURRED WEEKLY, FOR 10 WEEKS. THE PRIMARY OUTCOMES WERE RECRUITMENT RATE, INTERVENTION ATTENDANCE, AND RETENTION AT ASSESSMENTS. ADVERSE EVENT RATES AND PARTICIPANT SATISFACTION WERE ALSO MEASURED. PHYSICAL PERFORMANCE MEASURES OF GAIT, BALANCE, AND STRENGTH AND SELF-REPORT OUTCOME MEASURES WERE ADMINISTERED AT BASELINE AND 10-WEEKS. RESULTS: RECRUITMENT LASTED 6 MONTHS. RETENTION OF PARTICIPANTS AT THE 10-WEEK FOLLOW-UP WAS HIGH (89% - PERFORMANCE MEASURES; 98% - SELF-REPORT QUESTIONNAIRES). ATTENDANCE WAS GOOD WITH 82% OF YOGA AND 74% OF HEALTH EDUCATION PARTICIPANTS ATTENDING AT LEAST 50% OF THE SESSIONS. NO SERIOUS ADVERSE EVENTS WERE REPORTED. PATIENT SATISFACTION WITH THE INTERVENTIONS WAS HIGH. THE MEAN EFFECT SIZE FOR THE PHYSICAL PERFORMANCE MEASURES WAS 0.35 WITH SOME OVER 0.50. THE MEAN EFFECT SIZE FOR SELF-REPORT OUTCOME MEASURES WAS 0.36. CONCLUSIONS: RESULTS INDICATE THAT IT IS FEASIBLE TO CONDUCT A LARGER RCT OF YOGA FOR SEDENTARY OLDER ADULTS AT RISK FOR MOBILITY PROBLEMS. THE YOGA AND COMPARISON INTERVENTIONS WERE SAFE, WELL ACCEPTED, AND WELL ATTENDED. EFFECT SIZES SUGGEST YOGA MAY HAVE IMPORTANT BENEFITS FOR THIS POPULATION AND SHOULD BE STUDIED FURTHER. TRIAL REGISTRATION: CLINICALTRIALS # NCT03544879 ; RETROSPECTIVELY REGISTERED 4 JUNE, 2018. 2018 10 2374 56 WHICH CHRONIC LOW BACK PAIN PATIENTS RESPOND FAVORABLY TO YOGA, PHYSICAL THERAPY, AND A SELF-CARE BOOK? RESPONDER ANALYSES FROM A RANDOMIZED CONTROLLED TRIAL. PURPOSE: TO IDENTIFY BASELINE CHARACTERISTICS OF ADULTS WITH CHRONIC LOW BACK PAIN (CLBP) THAT PREDICT RESPONSE (I.E., A CLINICALLY IMPORTANT IMPROVEMENT) AND/OR MODIFY TREATMENT EFFECT ACROSS THREE NONPHARMACOLOGIC INTERVENTIONS. DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS. SUBJECTS: ADULTS WITH CLBP (N = 299). METHODS: WE REPORT PATIENT CHARACTERISTICS THAT WERE PREDICTORS OF RESPONSE AND/OR MODIFIED TREATMENT EFFECT ACROSS THREE 12-WEEK TREATMENTS: YOGA, PHYSICAL THERAPY [PT], AND A SELF-CARE BOOK. USING PRESELECTED CHARACTERISTICS, WE USED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF "RESPONSE," DEFINED AS A >/=30% IMPROVEMENT IN THE ROLAND MORRIS DISABILITY QUESTIONNAIRE. THEN, USING "RESPONSE" AS OUR OUTCOME, WE IDENTIFIED BASELINE CHARACTERISTICS THAT WERE TREATMENT EFFECT MODIFIERS BY TESTING FOR STATISTICAL INTERACTION (P < 0.05) ACROSS TWO COMPARISONS: 1) YOGA-OR-PT VS SELF-CARE AND 2) YOGA VS PT. RESULTS: OVERALL, 39% (116/299) OF PARTICIPANTS WERE RESPONDERS, WITH MORE RESPONDERS IN THE YOGA-OR-PT GROUP (42%) THAN THE SELF-CARE (23%) GROUP. THERE WAS NO DIFFERENCE IN PROPORTION RESPONDING TO YOGA (48%) VS PT (37%, ODDS RATIO [OR] = 1.5, 95% CONFIDENCE INTERVAL = 0.88 - 2.6). PREDICTORS OF RESPONSE INCLUDED HAVING MORE THAN A HIGH SCHOOL EDUCATION, A HIGHER INCOME, EMPLOYMENT, FEW DEPRESSIVE SYMPTOMS, LOWER PERCEIVED STRESS, FEW WORK-RELATED FEAR AVOIDANCE BELIEFS, HIGH PAIN SELF-EFFICACY, AND BEING A NONSMOKER. EFFECT MODIFIERS INCLUDED USE OF PAIN MEDICATION AND FEAR AVOIDANCE BELIEFS RELATED TO PHYSICAL ACTIVITY (BOTH P = 0.02 FOR INTERACTION). WHEN COMPARING YOGA OR PT WITH SELF-CARE, A GREATER PROPORTION WERE RESPONDERS AMONG THOSE USING PAIN MEDS (OR = 5.3), WHICH DIFFERED FROM THOSE NOT TAKING PAIN MEDS (OR = 0.94) AT BASELINE. WE ALSO FOUND GREATER TREATMENT RESPONSE AMONG THOSE WITH LOWER (OR = 7.0), BUT NOT HIGH (OR = 1.3), FEAR AVOIDANCE BELIEFS AROUND PHYSICAL ACTIVITY. CONCLUSIONS: OUR FINDINGS REVEALED IMPORTANT SUBGROUPS FOR WHOM REFERRAL TO YOGA OR PT MAY IMPROVE CLBP OUTCOMES. 2021 11 521 57 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 12 430 56 CAN YOGA OR PHYSICAL THERAPY FOR CHRONIC LOW BACK PAIN IMPROVE DEPRESSION AND ANXIETY AMONG ADULTS FROM A RACIALLY DIVERSE, LOW-INCOME COMMUNITY? A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO DETERMINE AND COMPARE THE EFFECT OF YOGA, PHYSICAL THERAPY (PT), AND EDUCATION ON DEPRESSIVE AND ANXIOUS SYMPTOMS IN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP). DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY NET HOSPITAL AND 7 COMMUNITY HEALTH CENTERS. PARTICIPANTS: A TOTAL OF 320 ADULTS WITH CLBP. INTERVENTION: YOGA CLASSES, PT SESSIONS, OR AN EDUCATIONAL BOOK. OUTCOME MEASURE: DEPRESSION AND ANXIETY WERE MEASURED USING THE PATIENT HEALTH QUESTIONNAIRE AND GENERALIZED ANXIETY DISORDER 7-ITEM SCALE, RESPECTIVELY, AT BASELINE, 12, AND 52 WEEKS. WE IDENTIFIED BASELINE AND MIDTREATMENT (6-WK) FACTORS ASSOCIATED WITH CLINICALLY MEANINGFUL IMPROVEMENTS IN DEPRESSIVE (>/=3 POINTS) OR ANXIOUS (>/=2 POINTS) SYMPTOMS AT 12 WEEKS. RESULTS: PARTICIPANTS (FEMALE=64%; MEAN AGE, 46.0+/-10.7 YEARS) WERE PREDOMINANTLY NON-WHITE (82%), LOW-INCOME (<$30,000/YEAR, 59%), AND HAD NOT RECEIVED A COLLEGE DEGREE (71%). MOST PARTICIPANTS HAD MILD OR WORSE DEPRESSIVE (60%) AND ANXIOUS (50%) SYMPTOMS. AT 12 WEEKS, YOGA AND PT PARTICIPANTS EXPERIENCED MODEST WITHIN-GROUP IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (MEAN DIFFERENCE [MD]=-1.23 [95% CI, -2.18 TO -0.28]; MD=-1.01 [95% CI, -2.05 TO -0.03], RESPECTIVELY). COMPARED WITH THE EDUCATION GROUP, 12-WEEK DIFFERENCES WERE NOT STATISTICALLY SIGNIFICANT, ALTHOUGH TRENDS FAVORED YOGA (MD=-0.71 [95% CI, -2.22 TO 0.81]) AND PT (MD= -0.32 [95% CI, -1.82 TO 1.18]). AT 12 WEEKS, IMPROVEMENTS IN ANXIOUS SYMPTOMS WERE ONLY FOUND IN PARTICIPANTS WHO HAD MILD OR MODERATE ANXIETY AT BASELINE. INDEPENDENT OF TREATMENT ARM, PARTICIPANTS WHO HAD 30% OR GREATER IMPROVEMENT IN PAIN OR FUNCTION MIDTREATMENT WERE MORE LIKELY TO HAVE A CLINICALLY MEANINGFUL IMPROVEMENT IN DEPRESSIVE SYMPTOMS (ODDS RATIO [OR], 1.82 [95% CI, 1.03-3.22]; OR, 1.79 [95% CI, 1.06-3.04], RESPECTIVELY). CONCLUSIONS: IN OUR SECONDARY ANALYSIS WE FOUND THAT DEPRESSION AND ANXIETY, COMMON IN THIS SAMPLE OF UNDERSERVED ADULTS WITH CLBP, MAY IMPROVE MODESTLY WITH PT AND YOGA. HOWEVER, EFFECTS WERE NOT SUPERIOR TO EDUCATION. IMPROVEMENTS IN PAIN AND FUNCTION ARE ASSOCIATED WITH A DECREASE IN DEPRESSIVE SYMPTOMS. MORE RESEARCH IS NEEDED TO OPTIMIZE THE INTEGRATION OF PHYSICAL AND PSYCHOLOGICAL WELL-BEING IN PT AND YOGA. 2021 13 2187 51 THE EFFECTS OF YOGA ON STUDENT MENTAL HEALTH: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: UNIVERSITIES AROUND THE WORLD ARE FACING AN EPIDEMIC OF MENTAL DISTRESS AMONG THEIR STUDENTS. THE PROBLEM IS TRULY A PUBLIC HEALTH ISSUE, AFFECTING MANY AND WITH SERIOUS CONSEQUENCES. THE GLOBAL BURDEN OF DISEASE-AGENDA CALLS FOR EFFECTIVE INTERVENTIONS WITH LASTING EFFECTS THAT HAVE THE POTENTIAL TO IMPROVE THE MENTAL HEALTH OF YOUNG ADULTS. IN THIS STUDY WE AIMED TO DETERMINE WHETHER YOGA, A POPULAR AND WIDELY AVAILABLE MIND-BODY PRACTICE, CAN IMPROVE STUDENT MENTAL HEALTH. METHODS: WE PERFORMED A RANDOMISED CONTROLLED TRIAL WITH 202 HEALTHY UNIVERSITY STUDENTS IN THE OSLO AREA. THE PARTICIPANTS WERE ASSIGNED TO A YOGA GROUP OR WAITLIST CONTROL GROUP IN A 1:1 RATIO BY A SIMPLE ONLINE RANDOMISATION PROGRAM. THE INTERVENTION GROUP WAS OFFERED 24 YOGA SESSIONS OVER 12 WEEKS. MEASUREMENTS WERE TAKEN AT WEEK 0 (BASELINE), WEEK 12 (POST-INTERVENTION), AND WEEK 24 (FOLLOW-UP). THE PRIMARY OUTCOME WAS PSYCHOLOGICAL DISTRESS ASSESSED BY THE HSCL-25 QUESTIONNAIRE. ANALYSIS WAS PERFORMED BASED ON THE INTENTION TO TREAT-PRINCIPLE. RESULTS: BETWEEN 24 JANUARY 2017, AND 27 AUGUST 2017, WE RANDOMLY ASSIGNED 202 STUDENTS TO A YOGA INTERVENTION GROUP (N = 100), OR WAITLIST CONTROL GROUP (N = 102). COMPARED WITH THE CONTROL GROUP, THE YOGA PARTICIPANTS DEMONSTRATED A SIGNIFICANT REDUCTION IN DISTRESS SYMPTOMS BOTH AT POST-INTERVENTION (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.15, 95% CI -0.26 TO -0.03, P = 0.0110) AND FOLLOW-UP (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.18, 95% CI -0.29 TO -0.06, P = 0.0025). SLEEP QUALITY ALSO IMPROVED AT POST-INTERVENTION AND FOLLOW-UP. NO ADVERSE EVENTS WERE REPORTED. CONCLUSIONS: OUR FINDINGS SUGGEST THAT YOGA HAS A MODERATELY LARGE AND LASTING EFFECT, AT LEAST FOR SOME MONTHS, REDUCING SYMPTOMS OF DISTRESS AND IMPROVING SLEEP QUALITY AMONG STUDENTS. FURTHER RESEARCH SHOULD SEEK WAYS TO ENHANCE THE EFFECT, ASSESS AN EVEN LONGER FOLLOW-UP PERIOD, INCLUDE ACTIVE CONTROL GROUPS, AND CONSIDER PERFORMING SIMILAR STUDIES IN OTHER CULTURAL SETTINGS.TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT04258540. 2020 14 131 41 A PRAGMATIC MULTI-CENTRED RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: TRIAL PROTOCOL. UNLABELLED: A SYSTEMATIC REVIEW REVEALED THREE SMALL RANDOMISED CONTROLLED TRIALS OF YOGA FOR LOW BACK PAIN, ALL OF WHICH SHOWED EFFECTS ON BACK PAIN THAT FAVOURED THE YOGA GROUP. TO BUILD ON THESE STUDIES A LARGER TRIAL, WITH LONGER TERM FOLLOW-UP, AND A NUMBER OF DIFFERENT YOGA TEACHERS DELIVERING THE INTERVENTION IS REQUIRED. THIS STUDY PROTOCOL DESCRIBES THE DETAILS OF A RANDOMISED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN, WHICH IS FUNDED BY ARTHRITIS RESEARCH CAMPAIGN (ARC) AND IS BEING CONDUCTED BY THE UNIVERSITY OF YORK. 262 PATIENTS WILL BE RECRUITED FROM GP PRACTICES IN 5 CENTRES IN ENGLAND. PATIENTS WILL BE RANDOMISED TO RECEIVE USUAL CARE OR 12 WEEKLY CLASSES OF YOGA. A YOGA PROGRAMME WILL BE DEVISED THAT CAN BE DELIVERED BY YOGA TEACHERS OF THE TWO MAIN NATIONAL YOGA ORGANISATIONS IN THE UK (BRITISH WHEEL OF YOGA AND IYENGAR YOGA ASSOCIATION (UK)). TRIAL REGISTRATION: CURRENT CONTROLLED TRIALS REGISTRY ISRCTN81079604 (DATE REGISTERED 30/03/2007). 2010 15 2681 40 YOGA IN SEDENTARY ADULTS WITH ARTHRITIS: EFFECTS OF A RANDOMIZED CONTROLLED PRAGMATIC TRIAL. OBJECTIVE: TO EVALUATE THE EFFECT OF INTEGRAL-BASED HATHA YOGA IN SEDENTARY PEOPLE WITH ARTHRITIS. METHODS: THERE WERE 75 SEDENTARY ADULTS AGED 18+ YEARS WITH RHEUMATOID ARTHRITIS (RA) OR KNEE OSTEOARTHRITIS RANDOMLY ASSIGNED TO 8 WEEKS OF YOGA (TWO 60-MIN CLASSES AND 1 HOME PRACTICE/WK) OR WAITLIST. POSES WERE MODIFIED FOR INDIVIDUAL NEEDS. THE PRIMARY ENDPOINT WAS PHYSICAL HEALTH [MEDICAL OUTCOMES STUDY SHORT FORM-36 (SF-36) PHYSICAL COMPONENT SUMMARY (PCS)] ADJUSTED FOR BASELINE; EXPLORATORY ADJUSTED OUTCOMES INCLUDED FITNESS, MOOD, STRESS, SELF-EFFICACY, SF-36 HEALTH-RELATED QUALITY OF LIFE (HRQOL), AND RA DISEASE ACTIVITY. IN EVERYONE COMPLETING YOGA, WE EXPLORED LONGTERM EFFECTS AT 9 MONTHS. RESULTS: PARTICIPANTS WERE MOSTLY FEMALE (96%), WHITE (55%), AND COLLEGE-EDUCATED (51%), WITH A MEAN (SD) AGE OF 52 YEARS (12 YRS). AVERAGE DISEASE DURATION WAS 9 YEARS AND 49% HAD RA. AT 8 WEEKS, YOGA WAS ASSOCIATED WITH SIGNIFICANTLY HIGHER PCS (6.5, 95% CI 2.0-10.7), WALKING CAPACITY (125 M, 95% CI 15-235), POSITIVE AFFECT (5.2, 95% CI 1.4-8.9), AND LOWER CENTER FOR EPIDEMIOLOGIC STUDIES DEPRESSION SCALE (-3.0, 95% CI -4.8 - -1.3). SIGNIFICANT IMPROVEMENTS (P < 0.05) WERE EVIDENT IN SF-36 ROLE PHYSICAL, PAIN, GENERAL HEALTH, VITALITY, AND MENTAL HEALTH SCALES. BALANCE, GRIP STRENGTH, AND FLEXIBILITY WERE SIMILAR BETWEEN GROUPS. TWENTY-TWO OUT OF 28 IN THE WAITLIST GROUP COMPLETED YOGA. AMONG ALL YOGA PARTICIPANTS, SIGNIFICANT (P < 0.05) IMPROVEMENTS WERE OBSERVED IN MEAN PCS, FLEXIBILITY, 6-MIN WALK, AND ALL PSYCHOLOGICAL AND MOST HRQOL DOMAINS AT 8 WEEKS WITH MOST STILL EVIDENT 9 MONTHS LATER. OF 7 ADVERSE EVENTS, NONE WERE ASSOCIATED WITH YOGA. CONCLUSION: PRELIMINARY EVIDENCE SUGGESTS YOGA MAY HELP SEDENTARY INDIVIDUALS WITH ARTHRITIS SAFELY INCREASE PHYSICAL ACTIVITY, AND IMPROVE PHYSICAL AND PSYCHOLOGICAL HEALTH AND HRQOL. CLINICAL TRIALS NCT00349869. 2015 16 269 51 ADAPTED YOGA TO IMPROVE PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE IN PHYSICALLY-INACTIVE OLDER ADULTS: A RANDOMISED CONTROLLED PILOT TRIAL. BACKGROUND: YOGA IS A HOLISTIC THERAPY OF EXPANDING POPULARITY, WHICH HAS THE POTENTIAL TO PRODUCE A RANGE OF PHYSICAL, MENTAL AND SOCIAL BENEFITS. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECTS OF AN ADAPTED YOGA PROGRAMME ON PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE IN PHYSICALLY-INACTIVE OLDER ADULTS. METHODS: IN THIS RANDOMISED CONTROLLED PILOT TRIAL, 52 OLDER ADULTS (90% FEMALE; MEAN AGE 74.8 YEARS, SD 7.2) WERE RANDOMISED 1:1 TO A YOGA PROGRAMME OR WAIT-LIST CONTROL. THE YOGA GROUP (N = 25) RECEIVED A PHYSICAL ACTIVITY EDUCATION BOOKLET AND WERE INVITED TO ATTEND TEN YOGA SESSIONS DURING A 12-WEEK PERIOD. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. MEASURES OF PHYSICAL FUNCTION (E.G., SHORT PHYSICAL PERFORMANCE BATTERY; SPPB), HEALTH STATUS (EQ-5D) AND MENTAL WELL-BEING (WARWICK-EDINBURGH MENTAL WELL-BEING SCALE; WEMWBS) WERE ASSESSED AT BASELINE AND 3 MONTHS. FEASIBILITY WAS ASSESSED USING COURSE ATTENDANCE AND ADVERSE EVENT DATA, AND PARTICIPANT INTERVIEWS. RESULTS: FORTY-SEVEN PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. MEDIAN CLASS ATTENDANCE WAS 8 (RANGE 3 TO 10). AT THE 3-MONTH FOLLOW-UP, THE YOGA GROUP HAD A HIGHER SPPB TOTAL SCORE COMPARED WITH THE CONTROL GROUP (MEAN DIFFERENCE 0.9, 95% CONFIDENCE INTERVAL [CI] -0.3 TO 2.0), A FASTER TIME TO RISE FROM A CHAIR FIVE TIMES (MEAN DIFFERENCE - 1.73 S, 95% CI -4.08 TO 0.62), AND BETTER PERFORMANCE ON THE CHAIR SIT-AND-REACH LOWER-LIMB FLEXIBILITY TEST (MEAN DIFFERENCE 5 CM, 95% CI 0 TO 10). THE YOGA GROUP ALSO HAD SUPERIOR HEALTH STATUS AND MENTAL WELL-BEING (VS. CONTROL) AT 3 MONTHS, WITH MEAN DIFFERENCES IN EQ-5D AND WEMWBS SCORES OF 0.12 (95% CI, 0.03 TO 0.21) AND 6 (95% CI, 1 TO 11), RESPECTIVELY. THE INTERVIEWS INDICATED THAT PARTICIPANTS VALUED ATTENDING THE YOGA PROGRAMME, AND THAT THEY EXPERIENCED A RANGE OF BENEFITS. CONCLUSIONS: THE ADAPTED YOGA PROGRAMME APPEARED TO BE FEASIBLE AND POTENTIALLY BENEFICIAL IN TERMS OF IMPROVING MENTAL AND SOCIAL WELL-BEING AND ASPECTS OF PHYSICAL FUNCTION IN PHYSICALLY-INACTIVE OLDER ADULTS. AN APPROPRIATELY-POWERED TRIAL IS REQUIRED TO CONFIRM THE FINDINGS OF THE PRESENT STUDY AND TO DETERMINE LONGER-TERM EFFECTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02663726 . 2017 17 2558 52 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 18 759 43 EFFECT OF STRUCTURED YOGA PROGRAM ON STRESS AND PROFESSIONAL QUALITY OF LIFE AMONG NURSING STAFF IN A TERTIARY CARE HOSPITAL OF DELHI-A SMALL SCALE PHASE-II TRIAL. BACKGROUND: NURSING STAFF SUFFER FROM VARIOUS LEVEL OF STRESS AND BURNOUT. WE AIMED TO ASSESS THE EFFECT OF 12 WEEKS OF STRUCTURED YOGA ON STRESS AND THE PROFESSIONAL QUALITY OF LIFE AMONG NURSING STAFF. DESIGN AND METHOD: AN OPEN-LABEL, PHASE-II RANDOMIZED CLINICAL TRIAL WAS UNDERTAKEN CONSIDERING A SAMPLE SIZE OF CONVENIENCE WAS DONE. IN SERVICE NURSING STAFF WERE RANDOMIZED (1:1) TO INTERVENTION GROUP AND WAIT-LIST CONTROL GROUP. PRIMARY OUTCOME WAS PERCEIVED STRESS WHICH WAS MEASURED BY PERCEIVED STRESS SCALE (PSS). SECONDARY MEASURES WERE PROFESSIONAL QUALITY MEASURED BY PROFESSIONAL QUALITY OF LIFE (PROQOL) SCALE, BLOOD PRESSURE, SERUM CORTISOL, AND HIGH-SENSITIVE C-REACTIVE PROTEIN. BOTH THE PER-PROTOCOL AND INTENTION TO TREAT ANALYSIS WAS DONE. RESULTS: TOTAL 113 PARTICIPANTS WERE ALLOCATED TO INTERVENTION GROUP (N = 58, MEAN = 35 YEARS, SD = 7.9 YEARS) AND WAIT-LIST CONTROL GROUP (N = 55, MEAN = 32.5 YEARS, SD = 6.8 YEARS). AFTER 12 WEEKS, 19 PARTICIPANTS OF INTERVENTION GROUP AND 32 PARTICIPANTS OF WAIT-LIST CONTROL GROUP WERE INCLUDED IN THE PER-PROTOCOL ANALYSIS. FOLLOW-UP MEAN PSS SCORE WAS 15.4 (95% CI 12.6-18.2, SD 5.8) IN INTERVENTION GROUP, 20.7 (95% CI 19.7-21.7, SD 2.8) IN WAIT-LIST CONTROL GROUP (P-VALUE < 0.0001). THE OTHER PARAMETERS DIDN'T DIFFER BETWEEN THE GROUPS AND FROM BASELINE TO END LINE TOO. CONCLUSIONS AND RELEVANCE: THE FINDING SHOWED SUPERVISED STRUCTURED YOGA MAY BE EFFICACIOUS TO REDUCE STRESS. STUDIES WITH LARGER SAMPLE SIZE ARE NEEDED TO CONFIRM THE FINDINGS. TRIAL REGISTRATION: IT WAS APPROVED BY THE INSTITUTE ETHICS COMMITTEE (REFERENCE NO: IECPG-543/20.12.2017, RT-57/31.01.2018) AND WAS REGISTERED PROSPECTIVELY IN THE CLINICAL TRIAL REGISTRY OF INDIA PROSPECTIVELY (NO. CTRI/2018/02/012206). 2021 19 1242 45 FEASIBILITY OF A YOGA INTERVENTION TO DECREASE PAIN IN OLDER WOMEN: A RANDOMIZED CONTROLLED PILOT STUDY. BACKGROUND: A SIGNIFICANT PROPORTION OF OLDER WOMEN SUFFER FROM CHRONIC PAIN, WHICH CAN DECREASE QUALITY OF LIFE. THE OBJECTIVE OF THIS PILOT RANDOMIZED STUDY WAS TO EVALUATE THE FEASIBILITY OF A FLOW-RESTORATIVE YOGA INTERVENTION DESIGNED TO DECREASE PAIN AND RELATED OUTCOMES AMONG WOMEN AGED 60 OR OLDER. METHODS: FLOW-RESTORATIVE YOGA CLASSES WERE HELD TWICE WEEKLY FOR 1 HOUR AND LED BY A CERTIFIED YOGA INSTRUCTOR. PARTICIPANTS RANDOMIZED TO THE INTERVENTION GROUP ATTENDED THE YOGA CLASSES FOR 12 WEEKS AND RECEIVED SUPPLEMENTAL MATERIALS FOR AT-HOME PRACTICE. THOSE RANDOMIZED TO THE CONTROL GROUP WERE ASKED TO MAINTAIN THEIR NORMAL DAILY ROUTINE. FEASIBILITY WAS EVALUATED USING RECRUITMENT AND RETENTION RATES, CLASS AND HOME PRACTICE ADHERENCE RATES, AND PARTICIPANT SATISFACTION SURVEYS. OUTCOME MEASURES (SELF-REPORTED PAIN, INFLAMMATORY MARKERS, FUNCTIONAL FITNESS, QUALITY OF LIFE, RESILIENCE, AND SELF-REPORTED PHYSICAL ACTIVITY) WERE ASSESSED AT BASELINE AND POST-INTERVENTION. PAIRED T-TESTS OR WILCOXON SIGNED-RANK TESTS WERE USED TO EXAMINE CHANGES IN OUTCOME MEASURES WITHIN TREATMENT GROUPS. RESULTS: THIRTY-EIGHT PARTICIPANTS WERE RECRUITED AND RANDOMIZED. PARTICIPANTS WERE PRIMARILY WHITE, COLLEGE-EDUCATED, AND HIGHER FUNCTIONING, DESPITE EXPERIENCING VARIOUS FORMS OF CHRONIC PAIN. ATTENDANCE AND RETENTION RATES WERE HIGH (91 AND 97%, RESPECTIVELY) AND THE MAJORITY OF PARTICIPANTS WERE SATISFIED WITH THE YOGA PROGRAM (89%) AND WOULD RECOMMEND IT TO OTHERS (87%). INTERVENTION PARTICIPANTS ALSO EXPERIENCED REDUCTIONS IN PAIN INTERFERENCE AND IMPROVEMENTS IN ENERGY AND SOCIAL FUNCTIONING. CONCLUSIONS: THIS PILOT STUDY PROVIDES ESSENTIAL DATA TO INFORM A FULL SCALE RANDOMIZED TRIAL OF FLOW-RESTORATIVE YOGA FOR OLDER WOMEN WITH CHRONIC PAIN. FUTURE STUDIES SHOULD EMPHASIZE STRATEGIES TO RECRUIT A MORE DIVERSE STUDY POPULATION, PARTICULARLY OLDER WOMEN AT HIGHER RISK OF DISABILITY AND FUNCTIONAL DECLINE. TRIAL REGISTRATION: CLINICALTRIALS.GOV , NCT03790098 . REGISTERED 31 DECEMBER 2018 - RETROSPECTIVELY REGISTERED. 2020 20 1943 53 SAHAJA YOGA IN THE MANAGEMENT OF MODERATE TO SEVERE ASTHMA: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: SAHAJA YOGA IS A TRADITIONAL SYSTEM OF MEDITATION BASED ON YOGIC PRINCIPLES WHICH MAY BE USED FOR THERAPEUTIC PURPOSES. A STUDY WAS UNDERTAKEN TO ASSESS THE EFFECTIVENESS OF THIS THERAPY AS AN ADJUNCTIVE TOOL IN THE MANAGEMENT OF ASTHMA IN ADULT PATIENTS WHO REMAINED SYMPTOMATIC ON MODERATE TO HIGH DOSES OF INHALED STEROIDS. METHODS: A PARALLEL GROUP, DOUBLE BLIND, RANDOMISED CONTROLLED TRIAL WAS CONDUCTED. SUBJECTS WERE RANDOMLY ALLOCATED TO SAHAJA YOGA AND CONTROL INTERVENTION GROUPS. BOTH THE YOGA AND THE CONTROL INTERVENTIONS REQUIRED THE SUBJECTS TO ATTEND A 2 HOUR SESSION ONCE A WEEK FOR 4 MONTHS. ASTHMA RELATED QUALITY OF LIFE (AQLQ, RANGE 0-4), PROFILE OF MOOD STATES (POMS), LEVEL OF AIRWAY HYPERRESPONSIVENESS TO METHACHOLINE (AHR), AND A DIARY CARD BASED COMBINED ASTHMA SCORE (CAS, RANGE 0-12) REFLECTING SYMPTOMS, BRONCHODILATOR USAGE, AND PEAK EXPIRATORY FLOW RATES WERE MEASURED AT THE END OF THE TREATMENT PERIOD AND AGAIN 2 MONTHS LATER. RESULTS: TWENTY ONE OF 30 SUBJECTS RANDOMISED TO THE YOGA INTERVENTION AND 26 OF 29 SUBJECTS RANDOMISED TO THE CONTROL GROUP WERE AVAILABLE FOR ASSESSMENT AT THE END OF TREATMENT. THE IMPROVEMENT IN AHR AT THE END OF TREATMENT WAS 1.5 DOUBLING DOSES (95% CONFIDENCE INTERVAL (CI) 0.0 TO 2.9, P=0.047) GREATER IN THE YOGA INTERVENTION GROUP THAN IN THE CONTROL GROUP. DIFFERENCES IN AQLQ SCORE (0.41, 95% CI -0.04 TO 0.86) AND CAS (0.9, 95% CI -0.9 TO 2.7) WERE NOT SIGNIFICANT (P>0.05). THE AQLQ MOOD SUBSCALE DID IMPROVE MORE IN THE YOGA GROUP THAN IN THE CONTROL GROUP (DIFFERENCE 0.63, 95% CI 0.06 TO 1.20), AS DID THE SUMMARY POMS SCORE (DIFFERENCE 18.4, 95% CI 0.2 TO 36.5, P=0.05). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS AT THE 2 MONTH FOLLOW UP ASSESSMENT. CONCLUSIONS: THIS RANDOMISED CONTROLLED TRIAL HAS SHOWN THAT THE PRACTICE OF SAHAJA YOGA DOES HAVE LIMITED BENEFICIAL EFFECTS ON SOME OBJECTIVE AND SUBJECTIVE MEASURES OF THE IMPACT OF ASTHMA. FURTHER WORK IS REQUIRED TO UNDERSTAND THE MECHANISM UNDERLYING THE OBSERVED EFFECTS AND TO ESTABLISH WHETHER ELEMENTS OF THIS INTERVENTION MAY BE CLINICALLY VALUABLE IN PATIENTS WITH SEVERE ASTHMA. 2002