Dataset Information

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.

ABSTRACT:

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 ConclusionIn 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.

SUBMITTER: Roseen EJ

PROVIDER: S-EPMC6957649 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Roseen Eric J EJ Gerlovin Hanna H Femia Alexandra A Cho Jae J Bertisch Suzanne S Redline Susan S Sherman Karen J KJ Saper Robert R

Journal of general internal medicine 20191030 1

<h4>Background</h4>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.<h4>Objective</h4>Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP.<h4>Design</h4>Secondary analysis of a randomized controlled trial.<h4>Setting</h4>Academic safety-net hospital and 7 affiliated community health centers.<h4>Participants</h4>A total of 320 ad ...[more]

PMID: 31667747

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Project description:BackgroundYoga 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.ObjectiveTo determine whether yoga is noninferior to PT for cLBP.Design12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927).SettingAcademic safety-net hospital and 7 affiliated community health centers.Participants320 predominantly low-income, racially diverse adults with nonspecific cLBP.InterventionParticipants 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.MeasurementsPrimary 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.ResultsOne-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.LimitationsParticipants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.ConclusionA manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:BackgroundChronic 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/designThis 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.DiscussionThis study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.Trial registrationClinicalTrials.gov: NCT02224183.

Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

Dataset Information

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

Objective

Design

Setting

Participants

Intervention

Main measures

Key results

Trial registration

Publications

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.

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