1 2824 166 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 2 1953 54 SECONDARY OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR VETERANS WITH CHRONIC LOW-BACK PAIN. CHRONIC LOW-BACK PAIN (CLBP) IS A PREVALENT CONDITION, AND RATES ARE HIGHER AMONG MILITARY VETERANS. CLBP IS A PERSISTENT CONDITION, AND TREATMENT OPTIONS HAVE EITHER MODEST EFFECTS OR A SIGNIFICANT RISK OF SIDE-EFFECTS, WHICH HAS LED TO RECENT EFFORTS TO EXPLORE MIND-BODY INTERVENTION OPTIONS AND REDUCE OPIOID MEDICATION USE. PRIOR STUDIES OF YOGA FOR CLBP IN COMMUNITY SAMPLES, AND THE MAIN RESULTS OF A RECENT TRIAL WITH MILITARY VETERANS, INDICATE THAT YOGA CAN REDUCE BACK-RELATED DISABILITY AND PAIN INTENSITY. SECONDARY OUTCOMES FROM THE TRIAL OF YOGA WITH MILITARY VETERANS ARE PRESENTED HERE. IN THE STUDY, 150 MILITARY VETERANS (VETERANS ADMINISTRATION PATIENTS) WITH CLBP WERE RANDOMIZED TO EITHER YOGA OR A DELAYED-TREATMENT GROUP RECEIVING USUAL CARE BETWEEN 2013 AND 2015. ASSESSMENTS OCCURRED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENT-TO-TREAT ANALYSES WERE CONDUCTED. YOGA CLASSES LASTING 60 MINUTES EACH WERE OFFERED TWICE WEEKLY FOR 12 WEEKS. YOGA SESSIONS CONSISTED OF PHYSICAL POSTURES, MOVEMENT, FOCUSED ATTENTION, AND BREATHING TECHNIQUES. HOME PRACTICE GUIDED BY A MANUAL WAS STRONGLY RECOMMENDED. THE PRIMARY OUTCOME MEASURE WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. SECONDARY OUTCOMES INCLUDED PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, FATIGUE, QUALITY OF LIFE, SELF-EFFICACY, AND MEDICATION USAGE. YOGA PARTICIPANTS IMPROVED MORE THAN DELAYED-TREATMENT PARTICIPANTS ON PAIN INTERFERENCE, FATIGUE, QUALITY OF LIFE, AND SELF-EFFICACY AT 12 WEEKS AND/OR 6 MONTHS. YOGA PARTICIPANTS HAD GREATER IMPROVEMENTS ACROSS A NUMBER OF IMPORTANT SECONDARY HEALTH OUTCOMES COMPARED TO CONTROLS. BENEFITS EMERGED DESPITE SOME VETERANS FACING CHALLENGES WITH ATTENDING YOGA SESSIONS IN PERSON. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS, WITH ATTENTION TO INCREASING ACCESSIBILITY OF YOGA PROGRAMS IN THIS POPULATION. 2020 3 2638 58 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 4 721 47 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 5 1413 29 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 6 536 58 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 7 2596 53 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 8 2639 52 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 9 2628 46 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 10 2830 47 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 11 1180 48 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 12 2322 49 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 13 2060 55 THE BENEFITS OF YOGA FOR WOMEN VETERANS WITH CHRONIC LOW BACK PAIN. OBJECTIVES: CHRONIC LOW BACK (CLBP) PAIN IS PREVALENT AMONG MILITARY VETERANS AND OFTEN LEADS TO FUNCTIONAL LIMITATIONS, PSYCHOLOGIC SYMPTOMS, LOWER QUALITY OF LIFE, AND HIGHER HEALTH CARE COSTS. AN INCREASING PROPORTION OF U.S. VETERANS ARE WOMEN, AND WOMEN VETERANS MAY HAVE DIFFERENT HEALTH CARE NEEDS THAN MEN VETERANS. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE IMPACT OF A YOGA INTERVENTION ON WOMEN AND MEN WITH CLBP. SUBJECTS/SETTING/INTERVENTION: VA PATIENTS WITH CLBP WERE REFERRED BY PRIMARY CARE PROVIDERS TO A CLINICAL YOGA PROGRAM. DESIGN: RESEARCH PARTICIPANTS COMPLETED A BRIEF BATTERY OF QUESTIONNAIRES BEFORE THEIR FIRST YOGA CLASS AND AGAIN 10 WEEKS LATER IN A SINGLE-GROUP, PRE-POST STUDY DESIGN. OUTCOME MEASURES: QUESTIONNAIRES INCLUDED MEASURES OF PAIN (PAIN SEVERITY SCALE), DEPRESSION (CESD-10), ENERGY/FATIGUE, AND HEALTH-RELATED QUALITY OF LIFE (SF-12). YOGA ATTENDANCE AND HOME PRACTICE OF YOGA WERE ALSO MEASURED. REPEATED-MEASURES ANALYSIS OF VARIANCE WAS USED TO ANALYZE GROUP DIFFERENCES OVER TIME WHILE CONTROLLING FOR BASELINE DIFFERENCES. RESULTS: THE 53 PARTICIPANTS WHO COMPLETED BOTH ASSESSMENTS HAD A MEAN AGE OF 53 YEARS, AND WERE WELL EDUCATED, 41% NONWHITE, 49% MARRIED, AND HAD VARYING EMPLOYMENT STATUS. WOMEN PARTICIPANTS HAD SIGNIFICANTLY LARGER DECREASES IN DEPRESSION (P=0.046) AND PAIN "ON AVERAGE" (P=0.050), AND LARGER INCREASES IN ENERGY (P=0.034) AND SF-12 MENTAL HEALTH (P=0.044) THAN MEN WHO PARTICIPATED. THE GROUPS DID NOT DIFFER SIGNIFICANTLY ON YOGA ATTENDANCE OR HOME PRACTICE OF YOGA. CONCLUSIONS: THESE RESULTS SUGGEST THAT WOMEN VETERANS MAY BENEFIT MORE THAN MEN VETERANS FROM YOGA INTERVENTIONS FOR CHRONIC BACK PAIN. CONCLUSIONS ARE TENTATIVE BECAUSE OF THE SMALL SAMPLE SIZE AND QUASI-EXPERIMENTAL STUDY DESIGN. A MORE RIGOROUS STUDY IS BEING DESIGNED TO ANSWER THESE RESEARCH QUESTIONS MORE DEFINITIVELY. 2012 14 162 58 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 1787 46 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 16 132 50 A PRAGMATIC MULTICENTERED RANDOMIZED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: ECONOMIC EVALUATION. STUDY DESIGN: MULTICENTERED RANDOMIZED CONTROLLED TRIAL WITH QUALITY OF LIFE AND RESOURCE USE DATA COLLECTED. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE COST-EFFECTIVENESS OF YOGA INTERVENTION PLUS USUAL CARE COMPARED WITH USUAL CARE ALONE FOR CHRONIC OR RECURRENT LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: YOGA HAS BEEN SHOWN AS AN EFFECTIVE INTERVENTION FOR TREATING CHRONIC OR RECURRENT LOW BACK PAIN. HOWEVER, THERE IS LITTLE EVIDENCE ON ITS COST-EFFECTIVENESS. THE DATA ARE EXTRACTED FROM A PRAGMATIC, MULTICENTERED, RANDOMIZED CONTROLLED TRIAL THAT HAS BEEN CONDUCTED TO EVALUATE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF A 12-WEEK PROGRESSIVE PROGRAM OF YOGA PLUS USUAL CARE IN PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. METHODS: WITH THIS TRIAL DATA, A COST-EFFECTIVENESS ANALYSIS DURING THE TIME PERIOD OF 12 MONTHS FROM BOTH PERSPECTIVES OF THE UK NATIONAL HEALTH SERVICE AND THE SOCIETAL IS PRESENTED. MAIN OUTCOME MEASURE IS AN INCREMENTAL COST PER QUALITY-ADJUSTED LIFE-YEAR (QALY). RESULTS: FROM THE PERSPECTIVE OF THE U.K. NATIONAL HEALTH SERVICE, YOGA INTERVENTION YIELDS AN INCREMENTAL COST-EFFECTIVENESS RATIO OF POUND13,606 PER QALY. GIVEN A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000, THE PROBABILITY OF YOGA INTERVENTION BEING COST-EFFECTIVE IS 72%. FROM THE PERSPECTIVE OF THE SOCIETY, YOGA INTERVENTION IS A DOMINANT TREATMENT COMPARED WITH USUAL CARE ALONE. THIS RESULT IS SURROUNDED BY FEWER UNCERTAINTIES-THE PROBABILITY OF YOGA BEING COST-EFFECTIVE REACHES 95% AT A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000. SENSITIVE ANALYSES SUGGEST THE SAME RESULTS THAT YOGA INTERVENTION IS LIKELY TO BE COST-EFFECTIVE IN BOTH PERSPECTIVES. CONCLUSION: ON THE BASIS OF THIS TRIAL, 12 WEEKLY GROUP CLASSES OF SPECIALIZED YOGA ARE LIKELY TO BE A COST-EFFECTIVE INTERVENTION FOR TREATING PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. 2012 17 2831 91 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 18 388 46 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES. 2018 19 2222 53 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 20 193 51 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