1 518 143 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013
2 2852 65 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017
3 461 52 CHANGES IN PERCEIVED STRESS AFTER YOGA, PHYSICAL THERAPY, AND EDUCATION INTERVENTIONS FOR CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: PERCEIVED STRESS AND MUSCULOSKELETAL PAIN ARE COMMON, ESPECIALLY IN LOW-INCOME POPULATIONS. STUDIES EVALUATING TREATMENTS TO REDUCE STRESS IN PATIENTS WITH CHRONIC PAIN ARE LACKING. WE AIMED TO QUANTIFY THE EFFECT OF TWO EVIDENCE-BASED INTERVENTIONS FOR CHRONIC LOW BACK PAIN (CLBP), YOGA AND PHYSICAL THERAPY (PT), ON PERCEIVED STRESS IN ADULTS WITH CLBP. METHODS: WE USED DATA FROM AN ASSESSOR-BLINDED, PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL, WHICH RECRUITED PREDOMINANTLY LOW-INCOME AND RACIALLY DIVERSE ADULTS WITH CLBP. PARTICIPANTS (N = 320) WERE RANDOMLY ASSIGNED TO 12 WEEKS OF YOGA, PT, OR BACK PAIN EDUCATION. WE COMPARED CHANGES IN THE 10-ITEM PERCEIVED STRESS SCALE (PSS-10) FROM BASELINE TO 12- AND 52-WEEK FOLLOW-UP AMONG YOGA AND PT PARTICIPANTS WITH THOSE RECEIVING EDUCATION. SUBANALYSES WERE CONDUCTED FOR PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS (PSS-10 SCORE >/=17). WE CONDUCTED SENSITIVITY ANALYSES USING VARIOUS IMPUTATION METHODS TO ACCOUNT FOR POTENTIAL BIASES IN OUR ESTIMATES DUE TO MISSING DATA. RESULTS: AMONG 248 PARTICIPANTS (MEAN AGE = 46.4 YEARS, 80% NONWHITE) COMPLETING ALL THREE SURVEYS, YOGA AND PT SHOWED GREATER REDUCTIONS IN PSS-10 SCORES COMPARED WITH EDUCATION AT 12 WEEKS (MEAN BETWEEN-GROUP DIFFERENCE = -2.6, 95% CONFIDENCE INTERVAL [CI] = -4.5 TO -0.66, AND MEAN BETWEEN-GROUP DIFFERENCE = -2.4, 95% CI = -4.4 TO -0.48, RESPECTIVELY). THIS EFFECT WAS STRONGER AMONG PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS. BETWEEN-GROUP EFFECTS HAD ATTENUATED BY 52 WEEKS. RESULTS WERE SIMILAR IN SENSITIVITY ANALYSES. CONCLUSIONS: YOGA AND PT WERE MORE EFFECTIVE THAN BACK PAIN EDUCATION FOR REDUCING PERCEIVED STRESS AMONG LOW-INCOME ADULTS WITH CLBP. 2020
4 2851 52 YOGA, PHYSICAL THERAPY, AND BACK PAIN EDUCATION FOR SLEEP QUALITY IN LOW-INCOME RACIALLY DIVERSE ADULTS WITH CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: POOR SLEEP IS COMMON AMONG ADULTS WITH CHRONIC LOW BACK PAIN (CLBP), BUT THE INFLUENCE OF CLBP TREATMENTS, SUCH AS YOGA AND PHYSICAL THERAPY (PT), ON SLEEP QUALITY IS UNDER STUDIED. OBJECTIVE: EVALUATE THE EFFECTIVENESS OF YOGA AND PT FOR IMPROVING SLEEP QUALITY IN ADULTS WITH CLBP. DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: A TOTAL OF 320 ADULTS WITH CLBP. INTERVENTION: TWELVE WEEKLY YOGA CLASSES, 1-ON-1 PT SESSIONS, OR AN EDUCATIONAL BOOK. MAIN MEASURES: SLEEP QUALITY WAS MEASURED USING THE PITTSBURGH SLEEP QUALITY INDEX (PSQI) GLOBAL SCORE (0-21) AT BASELINE, 12 WEEKS, AND 52 WEEKS. ADDITIONALLY, WE ALSO EVALUATED HOW THE PROPORTION OF PARTICIPANTS WHO ACHIEVED A CLINICALLY MEANINGFUL IMPROVEMENT IN SLEEP QUALITY (> 3-POINT REDUCTION IN PSQI) AT 12 WEEKS VARIED BY CHANGES IN PAIN AND PHYSICAL FUNCTION AT 6 WEEKS. KEY RESULTS: AMONG PARTICIPANTS (MEAN AGE = 46.0, 64% FEMALE, 82% NON-WHITE), NEARLY ALL (92%) REPORTED POOR SLEEP QUALITY (PSQI > 5) AT BASELINE. AT 12 WEEKS, MODEST IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED AMONG THE YOGA (PSQI MEAN DIFFERENCE [MD] = - 1.19, 95% CONFIDENCE INTERVAL [CI] - 1.82, - 0.55) AND PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) GROUPS. PARTICIPANTS WHO REPORTED A >/= 30% IMPROVEMENT IN PAIN OR PHYSICAL FUNCTION AT 6 WEEKS, COMPARED WITH THOSE WHO IMPROVED < 10%, WERE MORE LIKELY TO BE A SLEEP QUALITY RESPONDER AT 12 WEEKS (ODDS RATIO [OR] = 3.51, 95% CI 1.73, 7.11 AND OR = 2.16, 95% CI 1.18, 3.95, RESPECTIVELY). RESULTS WERE SIMILAR AT 52 WEEKS. CONCLUSION: IN A SAMPLE OF ADULTS WITH CLBP, VIRTUALLY ALL WITH POOR SLEEP QUALITY PRIOR TO INTERVENTION, MODEST BUT STATISTICALLY SIGNIFICANT IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED WITH BOTH YOGA AND PT. IRRESPECTIVE OF TREATMENT, CLINICALLY IMPORTANT SLEEP IMPROVEMENTS AT THE END OF THE INTERVENTION WERE ASSOCIATED WITH MID-INTERVENTION PAIN AND PHYSICAL FUNCTION IMPROVEMENTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01343927. 2020
5 460 59 CHANGES IN PAIN SELF-EFFICACY, COPING SKILLS, AND FEAR-AVOIDANCE BELIEFS IN A RANDOMIZED CONTROLLED TRIAL OF YOGA, PHYSICAL THERAPY, AND EDUCATION FOR CHRONIC LOW BACK PAIN. OBJECTIVE: WE EVALUATED EXERCISE INTERVENTIONS FOR COGNITIVE APPRAISAL OF CHRONIC LOW BACK PAIN (CLBP) IN AN UNDERSERVED POPULATION. METHODS: WE CONDUCTED A SECONDARY ANALYSIS OF THE BACK TO HEALTH TRIAL, SHOWING YOGA TO BE NONINFERIOR TO PHYSICAL THERAPY (PT) FOR PAIN AND FUNCTION OUTCOMES AMONG ADULTS WITH CLBP (N = 320) RECRUITED FROM PRIMARY CARE CLINICS WITH PREDOMINANTLY LOW-INCOME PATIENTS. PARTICIPANTS WERE RANDOMIZED TO 12 WEEKS OF YOGA, PT, OR EDUCATION. COGNITIVE APPRAISAL WAS ASSESSED WITH THE PAIN SELF-EFFICACY QUESTIONNAIRE (PSEQ), COPING STRATEGIES QUESTIONNAIRE (CSQ), AND FEAR-AVOIDANCE BELIEFS QUESTIONNAIRE (FABQ). USING MULTIPLE IMPUTATION AND LINEAR REGRESSION, WE ESTIMATED WITHIN- AND BETWEEN-GROUP CHANGES IN COGNITIVE APPRAISAL AT 12 AND 52 WEEKS, WITH BASELINE AND THE EDUCATION GROUP AS REFERENCES. RESULTS: PARTICIPANTS (MEAN AGE = 46 YEARS) WERE MAJORITY FEMALE (64%) AND MAJORITY BLACK (57%), AND 54% HAD AN ANNUAL HOUSEHOLD INCOME <$30,000. ALL THREE GROUPS SHOWED IMPROVEMENTS IN PSEQ (RANGE 0-60) AT 12 WEEKS (YOGA, MEAN DIFFERENCE [MD] = 7.0, 95% CONFIDENCE INTERVAL [CI]: 4.9, 9.0; PT, MD = 6.9, 95% CI: 4.7 TO 9.1; AND EDUCATION, MD = 3.4, 95% CI: 0.54 TO 6.3), WITH YOGA AND PT IMPROVEMENTS BEING CLINICALLY MEANINGFUL. AT 12 WEEKS, IMPROVEMENTS IN CATASTROPHIZING (CSQ, RANGE 0-36) WERE LARGEST IN THE YOGA AND PT GROUPS (MD = -3.0, 95% CI: -4.4 TO -1.6; MD = -2.7, 95% CI: -4.2 TO -1.2, RESPECTIVELY). CHANGES IN FABQ WERE SMALL. NO STATISTICALLY SIGNIFICANT BETWEEN-GROUP DIFFERENCES WERE OBSERVED ON PSEQ, CSQ, OR FABQ AT EITHER TIME POINT. MANY OF THE CHANGES OBSERVED AT 12 WEEKS WERE SUSTAINED AT 52 WEEKS. CONCLUSION: ALL THREE INTERVENTIONS WERE ASSOCIATED WITH IMPROVEMENTS IN SELF-EFFICACY AND CATASTROPHIZING AMONG LOW-INCOME, RACIALLY DIVERSE ADULTS WITH CLBP. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER NCT01343927. 2022
6 2558 60 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE. 2009
7 2831 60 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014
8 1699 66 PARTICIPANT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC IMPROVEMENT FROM YOGA FOR CHRONIC LOW BACK PAIN. CONTEXT: STUDIES SUGGEST THAT YOGA IS EFFECTIVE FOR MODERATE TO SEVERE CHRONIC LOW BACK PAIN (CLBP) IN DIVERSE PREDOMINANTLY LOWER SOCIOECONOMIC STATUS POPULATIONS. HOWEVER, LITTLE IS KNOWN ABOUT FACTORS ASSOCIATED WITH BENEFIT FROM THE YOGA INTERVENTION. OBJECTIVE: IDENTIFY FACTORS AT BASELINE INDEPENDENTLY ASSOCIATED WITH GREATER EFFICACY AMONG PARTICIPANTS IN A STUDY OF YOGA FOR CLBP. DESIGN: FROM SEPTEMBER-DECEMBER 2011, A 12-WEEK RANDOMIZED DOSING TRIAL WAS CONDUCTED COMPARING WEEKLY VS. TWICE-WEEKLY 75-MINUTE HATHA YOGA CLASSES FOR 95 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH NONSPECIFIC CLBP. PARTICIPANT CHARACTERISTICS COLLECTED AT BASELINE WERE USED TO DETERMINE FACTORS BEYOND TREATMENT ASSIGNMENT (REPORTED IN THE INITIAL STUDY) THAT PREDICTED OUTCOME. WE USED BIVARIATE TESTING TO IDENTIFY BASELINE CHARACTERISTICS ASSOCIATED WITH IMPROVEMENT IN FUNCTION AND PAIN, AND INCLUDED SELECT FACTORS IN A MULTIVARIATE LINEAR REGRESSION. SETTING: RECRUITMENT AND CLASSES OCCURRED IN AN ACADEMIC SAFETY-NET HOSPITAL AND FIVE AFFILIATED COMMUNITY HEALTH CENTERS IN BOSTON, MASSACHUSETTS. PARTICIPANTS: NINETY-FIVE ADULTS WITH NONSPECIFIC CLBP, AGES RANGING FROM 20-64 (MEAN 48) YEARS; 72 WOMEN AND 23 MEN. OUTCOME MEASURES: PRIMARY OUTCOMES WERE CHANGES IN BACK-RELATED FUNCTION (MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE, RMDQ; 0-23) AND MEAN LOW BACK PAIN INTENSITY (0-10) IN THE PREVIOUS WEEK, FROM BASELINE TO WEEK 12. RESULTS: ADJUSTING FOR GROUP ASSIGNMENT, BASELINE RMDQ, AGE, AND GENDER, FOREIGN NATIONALITY AND LOWER BASELINE SF36 PHYSICAL COMPONENT SCORE (PCS) WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN RMDQ. GREATER THAN HIGH SCHOOL EDUCATION LEVEL, CLBP LESS THAN 1 YEAR, AND LOWER BASELINE SF36 PCS WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN PAIN INTENSITY. OTHER DEMOGRAPHICS INCLUDING RACE, INCOME, GENDER, BMI, AND USE OF PAIN MEDICATIONS WERE NOT ASSOCIATED WITH EITHER OUTCOME. CONCLUSIONS: POOR PHYSICAL HEALTH AT BASELINE IS ASSOCIATED WITH GREATER IMPROVEMENT FROM YOGA IN BACK-RELATED FUNCTION AND PAIN. RACE, INCOME, AND BODY MASS INDEX DO NOT AFFECT THE POTENTIAL FOR A PERSON WITH LOW BACK PAIN TO EXPERIENCE BENEFIT FROM YOGA. 2014
9 430 57 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
10 465 42 CHARACTERISTICS AND PREDICTORS OF SHORT-TERM OUTCOMES IN INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY FOR TREATMENT OF CHRONIC LOW BACK PAIN. OBJECTIVE: TO COMPARE CLINICAL AND DEMOGRAPHIC CHARACTERISTICS OF INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY (PT) FOR TREATMENT OF CHRONIC LOW BACK PAIN (CLBP) AND TO EXAMINE PREDICTORS OF SHORT-TERM PAIN AND FUNCTIONAL OUTCOMES. DESIGN: DESCRIPTIVE, LONGITUDINAL STUDY. SETTINGS: A HOSPITAL-BASED CLINIC THAT OFFERS MODIFIED INTEGRAL YOGA CLASSES FOR CLBP AND 2 OUTPATIENT PT CLINICS THAT OFFER EXERCISE-BASED PT. PARTICIPANTS: ADULTS (N=53) WITH CLBP>/=12 WEEKS: YOGA (N=27), PT (N=26). METHODS: YOGA PARTICIPANTS ATTENDED A 6-WEEK, ONCE WEEKLY, 2-HOUR YOGA CLASS. PT PARTICIPANTS UNDERWENT TWICE WEEKLY, 1-HOUR INDIVIDUALIZED PT. DATA WERE COLLECTED AT BASELINE AND AT 6 WEEKS. GROUPS WERE COMPARED BY USING CHI2 AND INDEPENDENT SAMPLES T-TESTS. HIERARCHICAL LINEAR REGRESSION WAS USED TO PREDICT TREATMENT OUTCOMES. MAIN OUTCOME MEASURES: DISABILITY (ROLAND MORRIS DISABILITY QUESTIONNAIRE), HEALTH STATUS (RAND SHORT FORM 36 HEALTH SURVEY 1.0), PAIN BOTHERSOMENESS (NUMERICAL RATING SCALE), BACK PAIN SELF-EFFICACY (BACK PAIN SELF-EFFICACY SCALE), AND TREATMENT SATISFACTION. RESULTS: AT BASELINE, YOGA PARTICIPANTS WERE SIGNIFICANTLY LESS DISABLED (P=.013), HAD HIGHER HEALTH STATUS (P=.023), GREATER PAIN SELF-EFFICACY (P=.012), AND LESS AVERAGE PAIN BOTHERSOMENESS (P=.001) COMPARED WITH PT PARTICIPANTS. AT 6 WEEKS, WHEN CONTROLLING FOR BASELINE GROUP DIFFERENCES, GREATER PAIN SELF-EFFICACY WAS THE STRONGEST PREDICTOR FOR REDUCED PAIN AND HIGHER FUNCTION FOR THE ENTIRE SAMPLE. A SIGNIFICANT GROUP INTERACTION BY BASELINE PAIN SELF-EFFICACY PREDICTED DISABILITY AT 6 WEEKS. PT PARTICIPANTS WITH LOW PAIN SELF-EFFICACY REPORTED SIGNIFICANTLY GREATER DISABILITY THAN THOSE WITH HIGH PAIN SELF-EFFICACY. YOGA PARTICIPANTS WITH LOW AND HIGH PAIN SELF-EFFICACY HAD SIMILAR DISABILITY OUTCOMES. CONCLUSION: THESE FINDINGS STRENGTHEN EVIDENCE THAT SELF-EFFICACY IS ASSOCIATED WITH CLBP OUTCOMES, ESPECIALLY IN INDIVIDUALS SELF-SELECTING PT. FURTHER RESEARCH TO EVALUATE OUTCOMES AFTER YOGA AND PT IN PARTICIPANTS WITH LOW PAIN SELF-EFFICACY IS NEEDED. 2010
11 521 58 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS. 2005
12 638 42 DO PHYSICAL THERAPY AND YOGA IMPROVE PAIN AND DISABILITY THROUGH PSYCHOLOGICAL MECHANISMS? A CAUSAL MEDIATION ANALYSIS OF ADULTS WITH CHRONIC LOW BACK PAIN. OBJECTIVE: TO INVESTIGATE WHETHER INDIRECT EFFECTS VIA PSYCHOLOGICAL MECHANISMS EXPLAIN THE EFFECTS OF PHYSICAL THERAPY (PT) OR YOGA, VERSUS EDUCATION, ON BACK-RELATED OUTCOMES. DESIGN: MEDIATION ANALYSES USING DATA FROM A RANDOMIZED CONTROLLED TRIAL OF PT, YOGA, AND EDUCATION INTERVENTIONS FOR CHRONIC LOW BACK PAIN. METHODS: PRIMARY OUTCOMES WERE CHANGES IN BACK-RELATED PAIN ON THE 11-POINT NUMERICAL RATING SCALE AND DISABILITY ON THE MODIFIED 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE, MEASURED AT 52-WEEKS POST-RANDOMIZATION. HYPOTHESIZED MEDIATORS WERE 12-WEEK CHANGES IN PAIN SELF-EFFICACY, FEAR AVOIDANCE BELIEFS, DEPRESSION, ANXIETY, PERCEIVED STRESS, AND SLEEP QUALITY. WE USED CAUSAL MEDIATION ANALYSIS TO ESTIMATE THE TOTAL EFFECT, DIRECT EFFECT, INDIRECT EFFECT, AND PROPORTION MEDIATED. RESULTS: WE ANALYZED DATA FROM 230 ADULTS (MEAN AGE = 46.2 YEARS, 69.6% FEMALE, 79.6% NON-WHITE). IN THE PT VERSUS EDUCATION MODEL, WHEN THE MEDIATOR WAS PERCEIVED STRESS, THE TOTAL EFFECT ON DISABILITY WAS 2.6 POINTS (95% CI: 0.3, 4.9) AND DECOMPOSED INTO A DIRECT EFFECT OF 1.7 POINTS (95% CI: -0.4, 3.8) AND AN INDIRECT EFFECT 0.9 POINTS (95% CI: 0.1, 2.0; PROPORTION MEDIATED 34%). NO OTHER PSYCHOLOGICAL CONSTRUCT WAS A SIGNIFICANT MEDIATOR. CONCLUSION: IMPROVEMENTS IN PERCEIVED STRESS MEDIATED IMPROVEMENTS IN DISABILITY AFTER PT TREATMENT COMPARED TO EDUCATION. OTHER PSYCHOLOGICAL OUTCOMES DID NOT MEDIATE THE EFFECT OF YOGA OR PT ON PAIN OR DISABILITY OUTCOMES COMPARED TO EDUCATION. J ORTHOP SPORTS PHYS THER, EPUB 18 MAY 2022. DOI:10.2519/JOSPT.2022.10813. 2022
13 1224 39 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421. 2018
14 1787 52 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH. 2015
15 193 56 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011
16 2596 56 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158. 2017
17 2560 50 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK. 2011
18 20 36 "WE'RE ALL IN THIS TOGETHER": A QUALITATIVE STUDY OF PREDOMINANTLY LOW INCOME MINORITY PARTICIPANTS IN A YOGA TRIAL FOR CHRONIC LOW BACK PAIN. OBJECTIVE: TO EXPLORE THE EXPERIENCES OF LOW-INCOME MINORITY ADULTS TAKING PART IN A YOGA DOSING TRIAL FOR CHRONIC LOW BACK PAIN. DESIGN: INDIVIDUAL SEMI-STRUCTURED INTERVIEWS WERE CONDUCTED WITH NINETEEN PARTICIPANTS RECRUITED FROM A RANDOMIZED YOGA DOSING TRIAL FOR PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN. INTERVIEWS DISCUSSED THE IMPACT OF YOGA ON LOW BACK PAIN AND EMOTIONS; OTHER PERCEIVED ADVANTAGES OR DISADVANTAGES OF THE INTERVENTION; AND FACILITATORS AND BARRIERS TO PRACTICING YOGA. INTERVIEWS WERE AUDIO TAPED AND TRANSCRIBED, CODED USING ATLAS.TI SOFTWARE, AND ANALYZED WITH INDUCTIVE AND DEDUCTIVE THEMATIC ANALYSIS METHODS. SETTING: BOSTON MEDICAL CENTER, BOSTON, MA, USA. RESULTS: PARTICIPANTS VIEWED YOGA AS A MEANS OF PAIN RELIEF AND ATTRIBUTED IMPROVED MOOD, GREATER ABILITY TO MANAGE STRESS, AND ENHANCED RELAXATION TO YOGA. OVERALL, PARTICIPANTS FELT EMPOWERED TO SELF-MANAGE THEIR PAIN. SOME FOUND YOGA TO BE HELPFUL IN BEING MINDFUL OF THEIR EMOTIONS AND ACCEPTING OF THEIR PAIN. TRUST IN THE YOGA INSTRUCTORS WAS A COMMONLY CITED FACILITATOR FOR YOGA CLASS ATTENDANCE. LACK OF TIME, MOTIVATION, AND FEAR OF INJURY WERE REPORTED BARRIERS TO YOGA PRACTICE. CONCLUSIONS: YOGA IS A MULTIDIMENSIONAL TREATMENT FOR LOW BACK PAIN THAT HAS THE POTENTIAL TO FAVORABLY IMPACT HEALTH IN A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. 2016
19 1155 35 ENHANCING YOGA PARTICIPATION: A QUALITATIVE INVESTIGATION OF BARRIERS AND FACILITATORS TO YOGA AMONG PREDOMINANTLY RACIAL/ETHNIC MINORITY, LOW-INCOME ADULTS. YOGA IS UNDERUTILIZED AMONG RACIAL/ETHNIC MINORITIES AND LOW-INCOME POPULATIONS. TO ENHANCE PARTICIPATION AMONG THESE DEMOGRAPHIC GROUPS AND TO INFORM A FUTURE CLINICAL TRIAL, WE CONDUCTED A QUALITATIVE FORMATIVE INVESTIGATION, INFORMED BY THE SOCIAL CONTEXTUAL MODEL OF HEALTH BEHAVIOR CHANGE, TO IDENTIFY BARRIERS AND FACILITATORS TO YOGA THAT COULD IMPACT STUDY PARTICIPATION. WE RECRUITED TWENTY-FOUR RACIALLY/ETHNICALLY DIVERSE ADULTS, WITH AND WITHOUT PRIOR YOGA EXPERIENCE, FROM A LOW-INCOME, URBAN HOUSING COMMUNITY TO PARTICIPATE IN EITHER AN INDIVIDUAL INTERVIEW OR FOCUS GROUP. A THEMATIC DATA ANALYSIS APPROACH WAS EMPLOYED. BARRIERS TO YOGA ENGAGEMENT INCLUDED THE PERCEPTION THAT YOGA LACKS PHYSICALITY AND WEIGHT LOSS BENEFITS, FEAR OF INJURY, LACK OF ABILITY/SELF-EFFICACY TO PERFORM THE PRACTICES, PREFERENCE FOR OTHER PHYSICAL ACTIVITIES, AND SCHEDULING DIFFICULTIES. FACILITATORS OF YOGA ENGAGEMENT INCLUDED A QUALITY YOGA INSTRUCTOR WHO PROVIDES INDIVIDUALIZED INSTRUCTION, BEGINNER LEVEL CLASSES, AND PROMOTIONAL MESSAGING THAT HIGHLIGHTS THE POTENTIAL BENEFITS OF YOGA, SUCH AS STRESS REDUCTION. 2017
20 2824 52 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