1 1787 146 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 2 162 55 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 3 2628 40 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018 4 1488 47 INTER-METHOD RELIABILITY OF PAPER SURVEYS AND COMPUTER ASSISTED TELEPHONE INTERVIEWS IN A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR LOW BACK PAIN. BACKGROUND: LITTLE IS KNOWN ABOUT THE RELIABILITY OF DIFFERENT METHODS OF SURVEY ADMINISTRATION IN LOW BACK PAIN TRIALS. THIS ANALYSIS WAS DESIGNED TO DETERMINE THE RELIABILITY OF RESPONSES TO SELF-ADMINISTERED PAPER SURVEYS COMPARED TO COMPUTER ASSISTED TELEPHONE INTERVIEWS (CATI) FOR THE PRIMARY OUTCOMES OF PAIN INTENSITY AND BACK-RELATED FUNCTION, AND SECONDARY OUTCOMES OF PATIENT SATISFACTION, SF-36, AND GLOBAL IMPROVEMENT AMONG PARTICIPANTS ENROLLED IN A STUDY OF YOGA FOR CHRONIC LOW BACK PAIN. RESULTS: PAIN INTENSITY, BACK-RELATED FUNCTION, AND BOTH PHYSICAL AND MENTAL HEALTH COMPONENTS OF THE SF-36 SHOWED EXCELLENT RELIABILITY AT ALL THREE TIME POINTS; ICC SCORES RANGED FROM 0.82 TO 0.98. PAIN MEDICATION USE SHOWED GOOD RELIABILITY; KAPPA STATISTICS RANGED FROM 0.68 TO 0.78. PATIENT SATISFACTION HAD MODERATE TO EXCELLENT RELIABILITY; ICC SCORES RANGED FROM 0.40 TO 0.86. GLOBAL IMPROVEMENT SHOWED POOR RELIABILITY AT 6 WEEKS (ICC = 0.24) AND 12 WEEKS (ICC = 0.10). CONCLUSION: CATI SHOWS EXCELLENT RELIABILITY FOR PRIMARY OUTCOMES AND AT LEAST SOME SECONDARY OUTCOMES WHEN COMPARED TO SELF-ADMINISTERED PAPER SURVEYS IN A LOW BACK PAIN YOGA TRIAL. HAVING TWO RELIABLE OPTIONS FOR DATA COLLECTION MAY BE HELPFUL TO INCREASE RESPONSE RATES FOR CORE OUTCOMES IN BACK PAIN TRIALS. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT01761617. DATE OF TRIAL REGISTRATION: DECEMBER 4, 2012. 2014 5 2222 55 THE IMPACT OF MODIFIED HATHA YOGA ON CHRONIC LOW BACK PAIN: A PILOT STUDY. PURPOSE: THE PURPOSE OF THIS RANDOMIZED PILOT STUDY WAS TO EVALUATE A POSSIBLE DESIGN FOR A 6-WEEK MODIFIED HATHA YOGA PROTOCOL TO STUDY THE EFFECTS ON PARTICIPANTS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS: TWENTY-TWO PARTICIPANTS (M = 4; F = 17), BETWEEN THE AGES OF 30 AND 65, WITH CHRONIC LOW BACK PAIN (CLBP) WERE RANDOMIZED TO EITHER AN IMMEDIATE YOGA BASED INTERVENTION, OR TO A CONTROL GROUP WITH NO TREATMENT DURING THE OBSERVATION PERIOD BUT RECEIVED LATER YOGA TRAINING. METHODS: A SPECIFIC CLBP YOGA PROTOCOL DESIGNED AND MODIFIED FOR THIS POPULATION BY A CERTIFIED YOGA INSTRUCTOR WAS ADMINISTERED FOR ONE HOUR, TWICE A WEEK FOR 6 WEEKS. PRIMARY FUNCTIONAL OUTCOME MEASURES INCLUDED THE FORWARD REACH (FR) AND SIT AND REACH (SR) TESTS. ALL PARTICIPANTS COMPLETED OSWESTRY DISABILITY INDEX (ODI) AND BECK DEPRESSION INVENTORY (BDI) QUESTIONNAIRES. GUIDING QUESTIONS WERE USED FOR QUALITATIVE DATA ANALYSIS TO ASCERTAIN HOW YOGA PARTICIPANTS PERCEIVED THE INSTRUCTOR, GROUP DYNAMICS, AND THE IMPACT OF YOGA ON THEIR LIFE. ANALYSIS: TO ACCOUNT FOR DROP OUTS, THE DATA WERE DIVIDED INTO BETTER OR NOT CATEGORIES, AND ANALYZED USING CHI-SQUARE TO EXAMINE DIFFERENCES BETWEEN THE GROUPS. QUALITATIVE DATA WERE ANALYZED THROUGH FREQUENCY OF POSITIVE RESPONSES. RESULTS: POTENTIALLY IMPORTANT TRENDS IN THE FUNCTIONAL MEASUREMENT SCORES SHOWED IMPROVED BALANCE AND FLEXIBILITY AND DECREASED DISABILITY AND DEPRESSION FOR THE YOGA GROUP BUT THIS PILOT WAS NOT POWERED TO REACH STATISTICAL SIGNIFICANCE. SIGNIFICANT LIMITATIONS INCLUDED A HIGH DROPOUT RATE IN THE CONTROL GROUP AND LARGE BASELINE DIFFERENCES IN THE SECONDARY MEASURES. IN ADDITION, ANALYSIS OF THE QUALITATIVE DATA REVEALED THE FOLLOWING FREQUENCY OF RESPONSES (1) GROUP INTERVENTION MOTIVATED THE PARTICIPANTS AND (2) YOGA FOSTERED RELAXATION AND NEW AWARENESS/LEARNING. CONCLUSION: A MODIFIED YOGA-BASED INTERVENTION MAY BENEFIT INDIVIDUALS WITH CLB, BUT A LARGER STUDY IS NECESSARY TO PROVIDE DEFINITIVE EVIDENCE. ALSO, THE IMPACT ON DEPRESSION AND DISABILITY COULD BE CONSIDERED AS IMPORTANT OUTCOMES FOR FURTHER STUDY. ADDITIONAL FUNCTIONAL OUTCOME MEASURES SHOULD BE EXPLORED. THIS PILOT STUDY SUPPORTS THE NEED FOR MORE RESEARCH INVESTIGATING THE EFFECT OF YOGA FOR THIS POPULATION. 2004 6 2824 46 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183. 2016 7 1413 34 IMPLEMENTING YOGA INTO THE MANAGEMENT OF PATIENTS WITH REFRACTORY LOW BACK PAIN IN AN OUTPATIENT CLINIC SETTING. PURPOSE: TO EVALUATE THE EFFECTIVENESS OF IMPLEMENTING YOGA INTO THE TREATMENT OF PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: QUANTITATIVE ANALYSIS WITH OPPORTUNITY FOR QUALITATIVE FEEDBACK. METHOD: EFFECTIVENESS OF THIS COMPLEMENTARY TREATMENT WAS ASSESSED USING A PRETEST/POSTTEST DESIGN OF PATIENTS WHO VOLUNTEERED TO PARTICIPATE IN YOGA CLASSES AS PART OF THEIR BACK PAIN MANAGEMENT. MEASUREMENTS INCLUDED LOW BACK PAIN RATING, PERCEPTION OF BACK PAIN INTERFERENCE WITH DAILY ACTIVITIES, AND SELF-EFFICACY IN DEALING WITH CHRONIC LOW BACK PAIN. FINDINGS: ALTHOUGH NO STATISTICALLY SIGNIFICANT FINDINGS WERE FOUND DUE TO THE SMALL SAMPLE SIZE, MOST PARTICIPANTS DEMONSTRATED IMPROVED INDIVIDUAL SCORES ON ALL MEASUREMENT SURVEYS INCLUDING QUALITATIVE COMMENTS. CONCLUSION: BASED ON THE FINDINGS OF THIS PILOT STUDY, FURTHER STUDIES ON IMPLEMENTING YOGA INTO THE TREATMENT OF CHRONIC LOW BACK PAIN ARE ENCOURAGED. 2019 8 721 45 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 9 2830 36 YOGA VS STRETCHING IN VETERANS WITH CHRONIC LOWER BACK PAIN AND THE ROLE OF MINDFULNESS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FEASIBILITY OF RECRUITING, RANDOMIZING, ENROLLING, AND COLLECTING OUTCOME DATA ON VETERAN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP) WHO UNDERGO AN 8-WEEK, ACTIVE EXERCISE CLASS WITH MINDFULNESS (YOGA CLASS) AND WITHOUT (STRETCHING CLASS). METHODS: UNITED STATES VETERANS WITH CLBP BASED ON INCLUSION/EXCLUSION CRITERIA WERE RANDOMIZED TO 1 OF 2 GROUPS. THE STUDY DESIGN WAS A PILOT RANDOMIZED CONTROLLED TRIAL. TWENTY CLBP PATIENTS ATTENDED A YOGA CLASS OR STRETCHING CLASS ONCE PER WEEK FOR 8 WEEKS AT THE VETERANS AFFAIRS ROCHESTER OUTPATIENT CENTER, ROCHESTER, NEW YORK. THE FOLLOWING MEASUREMENTS WERE OBTAINED: RECRUITMENT OR ENROLLMENT DATA, COMPLIANCE DATA TO INCLUDE CLASS ATTENDANCE AND HOME EXERCISE, AND COMPLIANCE DATA REGARDING ABILITY TO COLLECT OUTCOME MEASURES AT BASELINE AND AT COMPLETION. OUTCOME MEASURES INCLUDED PAIN (PEG), QUALITY OF LIFE (PROMIS GLOBAL HEALTH SURVEY), SELF-EFFICACY (2-ITEM QUESTIONNAIRE), FEAR AVOIDANCE BELIEF, CATASTROPHIZING, AND SOCIAL ENGAGEMENT IN ADDITION TO QUALITATIVE CLINICIAN OPEN-ENDED QUESTIONS POSTINTERVENTION. RESULTS: FORTY-FIVE VETERANS WERE QUERIED REGARDING INTEREST IN PARTICIPATION. OF THESE, 34 (76%) MET THE STUDY'S CRITERIA. TWENTY (44%) AGREED TO PARTICIPATE AND WERE CONSENTED, RANDOMIZED, AND ENROLLED IN THE STUDY. INITIAL AND FINAL OUTCOME MEASURES WERE OBTAINED FOR EACH PARTICIPANT (100%). FORTY PERCENT ATTENDED MORE THAN 80% OF THE SESSIONS FOR BOTH YOGA AND STRETCHING GROUPS. CONCLUSION: THIS PILOT STUDY DEMONSTRATED FEASIBILITY OF RECRUITING, ENROLLING, AND COLLECTING OUTCOME DATA ON CLBP VETERAN PATIENTS PARTICIPATING IN YOGA AND STRETCHING CLASS. THE DATA FROM THIS PILOT WILL INFORM THE DEVELOPMENT OF A RANDOMIZED, COMPARATIVE EFFECTIVENESS STUDY OF YOGA WITH AND WITHOUT MINDFULNESS IN THE MANAGEMENT OF CLBP. 2020 10 2639 47 YOGA FOR VETERANS WITH CHRONIC LOW-BACK PAIN. OBJECTIVES: CHRONIC BACK PAIN AFFECTS A LARGE PROPORTION OF BOTH THE GENERAL POPULATION AND OF MILITARY VETERANS. ALTHOUGH NUMEROUS THERAPIES EXIST FOR TREATING CHRONIC BACK PAIN, THEY CAN BE COSTLY AND TEND TO HAVE LIMITED EFFECTIVENESS. THUS, DEMONSTRATING THE EFFICACY AND COST-EFFECTIVENESS OF ADDITIONAL TREATMENT ALTERNATIVES IS IMPORTANT. THE PURPOSE OF OUR STUDY WAS TO EXAMINE THE BENEFITS OF A YOGA INTERVENTION FOR VETERANS ADMINISTRATION (VA) PATIENTS. SUBJECTS/INTERVENTION: VA PATIENTS WITH CHRONIC BACK PAIN WERE REFERRED BY THEIR PRIMARY CARE PROVIDERS TO A YOGA PROGRAM AS PART OF CLINICAL CARE. BEFORE STARTING YOGA, A VA PHYSICIAN TRAINED IN YOGA EVALUATED EACH PATIENT TO ENSURE THAT THEY COULD PARTICIPATE SAFELY. DESIGN: THE RESEARCH STUDY CONSISTED OF COMPLETING A SHORT BATTERY OF QUESTIONNAIRES AT BASELINE AND AGAIN 10 WEEKS LATER. OUTCOME MEASURES: QUESTIONNAIRES INCLUDED MEASURES OF PAIN, DEPRESSION, ENERGY/FATIGUE, HEALTH-RELATED QUALITY OF LIFE, AND PROGRAM SATISFACTION. PAIRED T-TESTS WERE USED TO COMPARE BASELINE SCORES TO THOSE AT THE 10-WEEK FOLLOW-UP FOR THE SINGLE GROUP, PRE-POST DESIGN. CORRELATIONS WERE USED TO EXAMINE WHETHER YOGA ATTENDANCE AND HOME PRACTICE WERE ASSOCIATED WITH BETTER OUTCOMES. RESULTS: BASELINE AND FOLLOW-UP DATA WERE AVAILABLE FOR 33 PARTICIPANTS. PARTICIPANTS WERE VA PATIENTS WITH A MEAN AGE OF 55 YEARS. THEY WERE 21% FEMALE, 70% WHITE, 52% MARRIED, 68% COLLEGE GRADUATES, AND 44% WERE RETIRED. SIGNIFICANT IMPROVEMENTS WERE FOUND FOR PAIN, DEPRESSION, ENERGY/FATIGUE, AND THE SHORT FORM-12 MENTAL HEALTH SCALE. THE NUMBER OF YOGA SESSIONS ATTENDED AND THE FREQUENCY OF HOME PRACTICE WERE ASSOCIATED WITH IMPROVED OUTCOMES. PARTICIPANTS APPEARED HIGHLY SATISFIED WITH THE YOGA INSTRUCTOR AND MODERATELY SATISFIED WITH THE EASE OF PARTICIPATION AND HEALTH BENEFITS OF THE YOGA PROGRAM. CONCLUSIONS: PRELIMINARY DATA SUGGEST THAT A YOGA INTERVENTION FOR VA PATIENTS WITH CHRONIC BACK PAIN MAY IMPROVE THE HEALTH OF VETERANS. HOWEVER, THE LIMITATIONS OF A PRE-POST STUDY DESIGN MAKE CONCLUSIONS TENTATIVE. A LARGER RANDOMIZED, CONTROLLED TRIAL OF THE YOGA PROGRAM IS PLANNED. 2008 11 2596 54 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 2811 37 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 13 536 51 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY. 2010 14 501 52 COMMUNITY BASED YOGA CLASSES FOR TYPE 2 DIABETES: AN EXPLORATORY RANDOMISED CONTROLLED TRIAL. BACKGROUND: YOGA IS A POPULAR THERAPY FOR DIABETES BUT ITS EFFICACY IS CONTESTED. THE AIM OF THIS STUDY WAS TO EXPLORE THE FEASIBILITY OF RESEARCHING COMMUNITY BASED YOGA CLASSES IN TYPE 2 DIABETES WITH A VIEW TO INFORMING THE DESIGN OF A DEFINITIVE, MULTI-CENTRE TRIAL METHODS: THE STUDY DESIGN WAS AN EXPLORATORY RANDOMISED CONTROLLED TRIAL WITH IN-DEPTH PROCESS EVALUATION. THE SETTING WAS TWO MULTI-ETHNIC BOROUGHS IN LONDON, UK; ONE WITH AVERAGE AND ONE WITH LOW MEAN SOCIO-ECONOMIC DEPRIVATION SCORE. CLASSES WERE HELD AT A SPORTS CENTRE OR GP SURGERY. PARTICIPANTS WERE 59 PEOPLE WITH TYPE 2 DIABETES NOT TAKING INSULIN, RECRUITED FROM GENERAL PRACTICE LISTS OR OPPORTUNISTICALLY BY GENERAL PRACTICE STAFF. THE INTERVENTION GROUP WERE OFFERED 12 WEEKS OF A TWICE-WEEKLY 90-MINUTE YOGA CLASS; THE CONTROL GROUP WAS A WAITING LIST FOR THE YOGA CLASSES. BOTH GROUPS RECEIVED ADVICE AND LEAFLETS ON HEALTHY LIFESTYLE AND WERE ENCOURAGED TO EXERCISE. PRIMARY OUTCOME MEASURE WAS HBA1C. SECONDARY OUTCOME MEASURES INCLUDED ATTENDANCE, WEIGHT, WAIST CIRCUMFERENCE, LIPID LEVELS, BLOOD PRESSURE, UKPDS CARDIOVASCULAR RISK SCORE, DIABETES-RELATED QUALITY OF LIFE (ADDQOL), AND SELF-EFFICACY. PROCESS MEASURES WERE ATTENDANCE AT YOGA SESSIONS, SELF-REPORTED FREQUENCY OF PRACTICE BETWEEN TAUGHT SESSIONS, AND QUALITATIVE DATA (INTERVIEWS WITH PATIENTS AND THERAPISTS, ETHNOGRAPHIC OBSERVATION OF THE YOGA CLASSES, AND ANALYSIS OF DOCUMENTS INCLUDING MINUTES OF MEETINGS, CORRESPONDENCE, AND EXERCISE PLANS). RESULTS: DESPITE BROAD INCLUSION CRITERIA, AROUND TWO-THIRDS OF THE PATIENTS ON GP DIABETIC REGISTERS PROVED INELIGIBLE, AND 90% OF THE REMAINDER DECLINED TO PARTICIPATE. MEAN AGE OF PARTICIPANTS WAS 60 +/- 10 YEARS. ATTENDANCE AT YOGA CLASSES WAS AROUND 50%. NOBODY DID THE EXERCISES REGULARLY AT HOME. YOGA TEACHERS FELT THAT MOST PARTICIPANTS WERE UNSUITABLE FOR 'STANDARD' YOGA EXERCISES BECAUSE OF LIMITED FLEXIBILITY, LACK OF BASIC FITNESS, CO-MORBIDITY, AND LACK OF CONFIDENCE. THERE WAS A SMALL FALL IN HBA1C IN THE YOGA GROUP WHICH WAS NOT STATISTICALLY SIGNIFICANT AND WHICH WAS NOT SUSTAINED SIX MONTHS LATER, AND NO SIGNIFICANT CHANGE IN OTHER OUTCOME MEASURES. CONCLUSION: THE BENEFITS OF YOGA IN TYPE 2 DIABETES SUGGESTED IN SOME PREVIOUS STUDIES WERE NOT CONFIRMED. POSSIBLE EXPLANATIONS (APART FROM LACK OF EFFICACY) INCLUDE RECRUITMENT CHALLENGES; PRACTICAL AND MOTIVATIONAL BARRIERS TO CLASS ATTENDANCE; PHYSICAL AND MOTIVATIONAL BARRIERS TO ENGAGING IN THE EXERCISES; INADEQUATE INTENSITY AND/OR DURATION OF YOGA INTERVENTION; AND INSUFFICIENT PERSONALISATION OF EXERCISES TO INDIVIDUAL NEEDS. ALL THESE FACTORS SHOULD BE CONSIDERED WHEN DESIGNING FUTURE TRIALS. TRIAL REGISTRATION: NATIONAL RESEARCH REGISTER (1410) AND CURRENT CONTROLLED TRIALS (ISRCTN63637211). 2009 15 1180 46 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 16 1240 37 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION. 2019 17 1243 41 FEASIBILITY OF A YOGA, AEROBIC AND STRETCHING-TONING EXERCISE PROGRAM FOR ADULT CANCER SURVIVORS: THE STAYFIT TRIAL. BACKGROUND: THE USE OF YOGA AS A MIND-BODY PRACTICE HAS BECOME INCREASINGLY POPULAR AMONG CLINICAL POPULATIONS AND OLDER ADULTS WHO USE THIS PRACTICE TO MANAGE AGE AND CHRONIC DISEASE-RELATED SYMPTOMS. ALTHOUGH YOGA CONTINUES TO GAIN POPULARITY AMONG PRACTITIONERS AND RESEARCHERS, PILOT STUDIES THAT EXAMINE ITS FEASIBILITY AND ACCEPTABILITY, ESPECIALLY AMONG CANCER SURVIVORS, ARE LIMITED. FEASIBILITY STUDIES PLAY A CRITICAL ROLE IN DETERMINING WHETHER THE TARGET POPULATION IS LIKELY TO ENGAGE WITH LARGER SCALE EFFICACY AND EFFECTIVENESS TRIALS. IN THIS PAPER WE PRESENT FEASIBILITY AND ACCEPTABILITY DATA FROM A 12-WEEK RANDOMIZED CONTROLLED TRIAL (RCT) CONDUCTED WITH ADULT CANCER SURVIVORS. METHODS: PARTICIPANTS N = 78 (MEAN AGE: 55 YEARS) WERE RANDOMIZED TO ONE OF THREE GROUPS: A HATHA YOGA, AEROBIC EXERCISE, OR STRETCHING-TONING CONTROL GROUP WITH GROUP EXERCISE CLASSES HELD FOR 150 MIN/WEEK FOR 12 WEEKS. HEREIN WE REPORT FEASIBILITY AND ACCEPTABILITY, INCLUDING ENROLLMENT RATES, ATTENDANCE, ATTRITION AND ADVERSE EVENTS, AND PARTICIPANT FEEDBACK AND SATISFACTION DATA. RESULTS: OF THE 233 ADULTS SCREENED, 109 WERE ELIGIBLE AND 78 RANDOMIZED TO ONE OF THE THREE INTERVENTION ARMS. SESSION ATTENDANCE WAS HIGH FOR ALL GROUPS (75.5-89.5%) AND 17 PARTICIPANTS DROPPED OUT DURING THE 12-WEEK INTERVENTION. PROGRAM SATISFACTION WAS HIGH (4.8 OR HIGHER OUT OF 5) AND NO ADVERSE EVENTS WERE REPORTED. ONE COHORT (N = 15) OF THE INTERVENTION TRANSITIONED TO REMOTE INTERVENTION DELIVERY DUE TO THE COVID-19 PANDEMIC. FEASIBILITY DATA FROM THESE PARTICIPANTS SUGGESTED THAT SYNCHRONIZED GROUP EXERCISE CLASSES VIA ZOOM WITH A LIVE INSTRUCTOR WERE ACCEPTABLE AND ENJOYABLE. PARTICIPANT FEEDBACK REGARDING MOST AND LEAST HELPFUL ASPECTS OF THE PROGRAM AS WELL AS SUGGESTIONS FOR FUTURE YOGA INTERVENTIONS ARE SUMMARIZED. CONCLUSIONS: OVERALL, THE YOGA INTERVENTION WAS HIGHLY FEASIBLE AND ACCEPTABLE. THE FEASIBILITY PARAMETERS FROM THIS TRIAL CAN AID RESEARCHERS IN ESTIMATING RECRUITMENT RATES FOR DESIRED SAMPLE SIZES TO SUCCESSFULLY RANDOMIZE AND RETAIN CANCER SURVIVORS IN SHORT- AND LONG-TERM YOGA-BASED EFFICACY AND EFFECTIVENESS TRIALS. THE FINDINGS ALSO PROVIDE EVIDENCE TO CLINICIANS WHO CAN RECOMMEND UP TO 150 MIN OF A COMBINATION OF EXERCISES-AEROBIC, YOGA, OR STRETCHING-TONING TO THEIR CANCER PATIENTS IN ORDER TO IMPROVE HEALTH AND WELLBEING DURING CANCER SURVIVORSHIP. 2021 18 2609 45 YOGA FOR QUALITY OF LIFE IN INDIVIDUALS WITH CHRONIC DISEASE: A SYSTEMATIC REVIEW. BACKGROUND: CHRONIC DISEASES, INCLUDING HEART DISEASE, STROKE, CANCER, AND CHRONIC PULMONARY DISEASE ARE THE LEADING CAUSES OF DEATH AND DISABILITY WORLDWIDE. COMPOUNDING SYMPTOMS AND LOSS OF FUNCTION, PEOPLE LIVING WITH CHRONIC DISEASE OFTEN EXPERIENCE REDUCED QUALITY OF LIFE (QOL). VARIOUS PHYSICAL AND MENTAL PRACTICES HAVE BEEN SHOWN TO RELIEVE STRESS AND IMPROVE QOL. YOGA IS A PHYSICAL AND MENTAL PRACTICE THAT MAY BE A VIABLE APPROACH FOR IMPROVING QOL IN PEOPLE WITH CHRONIC DISEASE. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE AND SUMMARIZE THE EVIDENCE FOR THE EFFECTIVENESS OF YOGA ON QOL IN PATIENTS WITH CHRONIC DISEASE. DESIGN: THE STUDY DESIGN WAS A A SYSTEMATIC REVIEW WITH QUALITATIVE SYNTHESIS. METHODS: WE INCLUDED RANDOMIZED CONTROLLED TRIALS THAT EVALUATED THE EFFECT OF YOGA ON QOL OR HEALTH-RELATED QOL (HRQOL) FOR INDIVIDUALS WITH CHRONIC DISEASE. WE INCLUDED ONLY STUDIES THAT USED AT LEAST 1 PREVIOUSLY VALIDATED MEASURE OF QOL OR HRQOL AND SPECIFIED A MINIMUM DURATION OF FOLLOW-UP OF AT LEAST 1 WK. INTERVENTIONS: WE INCLUDED BOTH MOVEMENT-BASED AND BREATH-BASED YOGA PRACTICES. STUDIES THAT INCLUDED YOGA AS PART OF A LARGER INTERVENTION PROGRAM (EG, MINDFULNESS-BASED STRESS REDUCTION TRAINING) OR STUDIES THAT DID NOT PROVIDE FINDINGS SPECIFIC TO YOGA WERE EXCLUDED. PRIMARY OUTCOME MEASURES: THE PRIMARY OUTCOME ANALYZED WAS IMPROVEMENT IN QOL AS MEASURED BY A VALIDATED QOL OR HRQOL SCALE. RESULTS: AMONG THE 1488 STUDIES THAT WERE IDENTIFIED ON INITIAL SEARCH, 7 ARTICLES MET ALL INCLUSION CRITERIA. FIVE STUDIES REPORTED A STATISTICALLY SIGNIFICANT ADVANTAGE OVER USUAL CARE ALONE FOR IMPROVEMENT OF QOL IN PATIENTS WITH CHRONIC DISEASE, BUT THE CLINICAL SIGNIFICANCE OF THE DIFFERENCES WAS CLEAR IN ONLY 1 TRIAL. WE FOUND CONSIDERABLE HETEROGENEITY AMONG THE INCLUDED STUDIES AND STUDY QUALITY WAS GENERALLY LOW. CONCLUSIONS: MORE HIGH-QUALITY RESEARCH IS NEEDED TO DETERMINE THE VALUE OF YOGA AS AN ADJUNCTIVE APPROACH TO IMPROVING QOL IN PATIENTS WITH CHRONIC DISEASE. 2019 19 2763 32 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893. 2021 20 2322 36 TREATMENT OF CHRONIC LOWER BACK PAIN: STUDY PROTOCOL OF A COMPARATIVE EFFECTIVENESS STUDY ON YOGA, EURYTHMY THERAPY, AND PHYSIOTHERAPEUTIC EXERCISES. BACKGROUND: WE AIM TO COMPARE THE EFFECTIVENESS OF 3 ACTIVE INTERVENTIONS, I.E., YOGA, EURYTHMY THERAPY, AND PHYSIOTHERAPEUTIC EXERCISE, ON CHRONIC LOWER BACK PAIN. METHODS: IN THIS RANDOMIZED CONTROLLED TRIAL OVER 16 WEEKS (8 WEEKS OF INTERVENTION, 8 WEEKS OF FOLLOW-UP), DATA OF INDIVIDUALS WITH CHRONIC LOWER BACK PAIN WILL BE ANALYZED. INTERVENTIONS ARE IMPLEMENTED AS GROUP SESSIONS (75 MIN) ONCE PER WEEK. PARTICIPANTS RECEIVE A MANUAL FOR HOME-BASED PRACTICE AND ARE ASSESSED BEFORE AND AT THE END OF THE 8-WEEK INTERVENTION PERIOD, AND AT THE END OF AN 8-WEEK FOLLOW-UP PERIOD. STANDARDIZED QUESTIONNAIRES ARE: THE ROLAND-MORRIS DISABILITY SCORE, VISUAL ANALOG SCALES MEASURING INTENSITY OF PAIN, THE BRIEF MULTIDIMENSIONAL LIFE SATISFACTION SCALE, THE PERCEIVED STRESS SCALE, THE INNER CORRESPONDENCE WITH THE PRACTICES QUESTIONNAIRE, THE FREIBURG MINDFULNESS QUESTIONNAIRE, THE GENERAL SELF-EFFICACY SCALE, A SELF-REGULATION QUESTIONNAIRE, THE INTERNAL COHERENCE SCALE, A PAIN DIARY (REGISTERING THE NEED OF ANALGESIC MEDICATION), AND A QUESTIONNAIRE ON THE PATIENTS' EXPECTATION THAT THE INTERVENTIONS WILL BE EFFECTIVE IN REDUCING PAIN AND HOW STRONG THIS REDUCTION MIGHT BE (2 SINGLE ITEMS), ETC. DISCUSSION: THIS LARGE MULTICENTER STUDY WILL PROVIDE EVIDENCE ON THE EFFECTIVENESS OF 3 CONTRASTING MOVEMENT-ORIENTATED TREATMENTS THAT SHARE SOME SIMILARITIES BUT DIFFER IN ESSENTIAL DETAILS: YOGA, EURYTHMY THERAPY, AND PHYSIOTHERAPEUTIC EXERCISES. IT WILL PROVIDE IMPORTANT DATA ON NON-PHARMACOLOGICAL OPTIONS TO TREAT LOWER BACK PAIN IN A LARGE GROUP OF AFFECTED INDIVIDUALS. 2018