Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial

Abstract

Objective: To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP).

Design: 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone).

Setting: Outpatient.

Subjects: Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months.

Methods: The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein).

Results: Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits.

Conclusions: Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP.

Trial registration: ClinicalTrials.gov NCT01775995.

Keywords: Chronic Low Back Pain; Cognitive Behavioral Therapy; Long-Term Opioid Therapy; Mindfulness Meditation.

Figure 1

Study flow diagram.

Figure 2

Change in pain severity, disability, and pain acceptance ratings from baseline to 26 weeks by group status (N = 35): (A) Box-plot presentation. (B) Percentage of participants reporting a given score change.

Figure 3

Comparison of average pain intensity and unpleasantness ratings of thermal stimuli between meditation-CBT (N = 20) and control (N = 14) participants at baseline, 8, and 26 weeks. The lines represent the average estimate of quadratic function for the relationship between stimulus temperatures and pain ratings; the markers represent the average pain rating at each temperature with error bars for the standard error of the mean (SEM). Significant differences between the groups for the slope of the quadratic function were observed for pain intensity and unpleasantness ratings at both 8 and 26 weeks (P < 0.05).

Figure 4

Comparison between consistent and inconsistent meditators, and control group participants. (A) Self-reported outcomes: change over time in pain severity, disability (ODI), and pain acceptance (CPAQ) ratings for 10 consistent and 11 inconsistent meditators, and 14 controls; outcomes collected at baseline (BL), 8 weeks (8 W), and 26 weeks (26 W). (B) Pain sensitivity measures: average ratings of pain intensity and unpleasantness to thermal stimuli at 26 weeks for 10 consistent and 10 inconsistent meditators, and 14 controls. Average estimate of quadratic function for the relationship between stimulus temperature and rating is included; error bars represent the standard error of the mean.