Dataset Information

Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.

ABSTRACT:

Background

Improving physical function among patients with chronic pain is critical for reducing disability and healthcare costs. However, mechanisms underlying improvement in patient-reported, performance-based, and ambulatory physical function in chronic pain remain poorly understood.

Purpose

To explore psychosocial mediators of improvement in patient-reported, performance-based, and objective/accelerometer-measured physical function among participants in a mind-body activity program.

Methods

Individuals with chronic pain were randomized to one of two identical 10-week mind-body activity interventions aimed at improving physical function with (GetActive-Fitbit; N=41) or without (GetActive; N=41) a Fitbit device. They completed self-reported (WHODAS 2.0), performance-based (6-minute walk test), and objective (accelerometer-measured step-count) measures of physical function, as well as measures of kinesiophobia (Tampa Kinesiophobia Scale), mindfulness (CAMS-R), and pain resilience (Pain Resilience Scale) before and after the intervention. We conducted secondary data analyses to test mediation via mixed-effects modeline.

Results

Improvements in patient-reported physical function were fully and uniquely mediated by kinesiophobia (Completely Standardized Indirect Effect (CSIE)=.18; CI=0.08, 0.30; medium-large effect size), mindfulness (CSIE=-.14; CI=-25, -.05; medium effect size) and pain resilience (CSIE=-.07; CI=-.16, -.005; small-medium effect size). Improvements in performance-based physical function were mediated only by kinesiophobia (CSIE=-.11; CI=-23, -.008; medium effect size). No measures mediated improvements in objective (accelerometer measured) physical function.

Conclusion

Interventions aiming to improve patient-reported physical function in patients with chronic pain may benefit from skills that target kinesiophobia, mindfulness, and pain resilience, while those focused on improving performance-based physical function should target primarily kinesiophobia. More research is needed to understand mechanisms of improvement in objective, accelerometer-measured physical function.

Trial registration

ClinicalTrials.gov NCT03412916.

SUBMITTER: Greenberg J

PROVIDER: S-EPMC7872894 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.

Greenberg Jonathan J Mace Ryan A RA Bannon Sarah M SM Kulich Ronald J RJ Vranceanu Ana-Maria AM

Journal of pain research 20210205

<h4>Background</h4>Improving physical function among patients with chronic pain is critical for reducing disability and healthcare costs. However, mechanisms underlying improvement in patient-reported, performance-based, and ambulatory physical function in chronic pain remain poorly understood.<h4>Purpose</h4>To explore psychosocial mediators of improvement in patient-reported, performance-based, and objective/accelerometer-measured physical function among participants in a mind-body activity pr ...[more]

PMID: 33574699

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Project description:BACKGROUND:Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE:This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS:Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS:Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS:These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. TRIAL REGISTRATION:ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.

Project description:ImportanceTreatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed.ObjectiveTo determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP.Design, setting, and participantsThis single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (≥11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ≥3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015.InterventionsThe intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the "10 Keys" to Healthy Aging.Main outcomes and measuresFollow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted.ResultsOf 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively).Conclusions and relevanceA mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability.Trial registrationclinicaltrials.gov Identifier: NCT01405716.

Dataset Information

Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.

Background

Purpose

Methods

Results

Conclusion

Trial registration

Publications

Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.

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