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Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

ABSTRACT: Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n?=?116), CBT (n?=?113), or usual care (n?=?113).CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.Coprimary outcomes were the percentages of participants with clinically meaningful (?30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P?=?.04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P?=?.01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.clinicaltrials.gov Identifier: NCT01467843.

SUBMITTER: Cherkin DC

PROVIDER: S-EPMC4914381 | biostudies-literature | 2016 Mar 22-29

REPOSITORIES: biostudies-literature

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Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Cherkin Daniel C DC Sherman Karen J KJ Balderson Benjamin H BH Cook Andrea J AJ Anderson Melissa L ML Hawkes Rene J RJ Hansen Kelly E KE Turner Judith A JA

JAMA 20160301 12

<h4>Importance</h4>Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.<h4>Objective</h4>To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.<h4>Design, setting, and participants</h4>Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enroll ...[more]

PMID: 27002445

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Project description:BackgroundNonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated.ObjectiveIn response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments.MethodsThe multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy.ResultsParticipant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021.ConclusionsThis center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments.Trial registrationClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475.International registered report identifier (irrid)PRR1-10.2196/37823.

Project description:BackgroundChronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP.MethodsThis is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported.ResultsMedium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d = - .49).ConclusionsThe findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare.Trial registrationClinicaltrials.gov, NCT03687762.

Project description:BackgroundChronic low back pain is a common and sometimes disabling condition, and mindfulness-based stress reduction is recommended as a first line of therapy. This study tested whether different descriptions of mindfulness training altered based on influential intervention characteristics increased adoption intentions.MethodsPeople with chronic low back pain (n = 452) were randomized to review one of four mindfulness training descriptions in an online survey using a 2 × 2 factorial design. The first factor was evidence strength and quality with relative advantage (ER). The second factor was adaptability, trialability, complexity, and design quality and packaging (AD). Each factor had two levels: a description of standardized mindfulness training that described each intervention characteristic and a patient-centered description emphasizing flexibility and patient testimonials. The primary outcomes were intentions to try mindfulness training and practice mindfulness at home. Using structural equation modeling with a bootstrapped distribution, we tested six mediators, three of which are Theory of Planned Behavior predictors of intention-self-efficacy, norms, and attitudes- and the other three are predictors of adoption-feasibility, appropriateness, and acceptability.ResultsOverall, the mindfulness training descriptions were not associated with an increase in intentions compared to the classic vignette (11/12 p's > 0.05). Most descriptions were unrelated to mediators except the classic ER with patient-centered AD was associated with higher self-efficacy/control and feasibility (p's ≤ 0.05; standardized effect range: 0.111-0.125). Self-efficacy/control (training standardized coefficient: 0.531, home: 0.686), norms (training: 0.303, home: 0.256), and attitudes (training: 0.316, home: 0.293) were all positively associated with intentions to adopt mindfulness training and home practice. Feasibility (training: 0.185; home: 0.293) and acceptability (training: 0.639; home: 0.554) were positively related to intentions to adopt mindfulness training. Appropriateness was related to intentions to adopt home practice (0.187) but not mindfulness training (0.100). None of the indirect effects from experimental group to intentions was significant (all p's > 0.05).ConclusionsSelf-efficacy/control and acceptability may be key mediators for increasing patient adoption of mindfulness. Because experimental manipulation did not substantially change intentions to adopt mindfulness, the presentation and delivery of MBSR may need to be tailored to the individual patient's needs rather than a specific format for chronic low back pain.

Project description:BackgroundChronic back pain is prevalent in Brazil, leading to enormous healthcare costs and social burdens. It also disproportionately affects low-income and less-healthy people.ObjectivesThis study examines the associations of chronic back pain with biological, psychological, and social factors; how it limits usual activities; and how chronic back pain influences the use of treatment services.MethodsUsing Brazil's National Health Survey (PNS-2019), multivariate logistic regressions were conducted to examine how biological, psychological, and social factors correlate with chronic back pain, limitations on usual activities, and pain treatment.ResultsPNS-2019 data showed that 23.4% (95% CI 22.8-24.0) of Brazilian adults aged over 20 reported back pain. A higher prevalence of chronic back pain was associated with biological factors (older age, being female, overweight or obese, current smoking, and having more chronic conditions), lower social conditions (low education, low per capita household income, non-married, and living in rural areas), and poor psychological health (more depressive symptoms). Chronic back pain is more likely to limit usual activities among those with low social conditions (lower education, lower income), poor physical and behavioral health (obese, current smokers, and those with a greater number of chronic conditions), and worse psychological health (more depressive symptoms). However, married people and those who do not consume alcohol were also more likely to report limited activities. Among those with back pain, 68% received at least one form of treatment. Those with intense limitations on their usual activities were 2.2 times as likely to report treatment. People with higher social conditions (higher income, college education, and private health insurance) were more likely to receive treatment.ConclusionThe results show significant biological, psychological, and social disparities in the prevalence of chronic back pain in Brazil. The findings point to the need for tailored policies and prevention programs with attention to vulnerable groups. Even though Brazil has universal health care, those with better socioeconomic conditions are more likely to receive treatment.

Project description:ImportanceIt is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.ObjectiveTo determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.Design, setting, and participantsA 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source.InterventionsThe intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.Main outcomes and measuresCoprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12.ResultsOf the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, -1.1; 95% CI, -1.4 to -0.7), disability (mean difference, -2.2; 95% CI, -3.1 to -1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.Conclusions and relevanceChiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.Trial registrationClinicalTrials.gov Identifier: NCT01692275.

Dataset Information

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Publications

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

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