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Randomized Controlled Trial
. 2021 Aug 2;4(8):e2113401.
doi: 10.1001/jamanetworkopen.2021.13401.

Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial

Beth D Darnall  1 , Anuradha Roy  1 , Abby L Chen  1 , Maisa S Ziadni  1 , Ryan T Keane  1 , Dokyoung S You  1 , Kristen Slater  1 , Heather Poupore-King  1 , Ian Mackey  1 , Ming-Chih Kao  1 , Karon F Cook  2 , Kate Lorig  3 , Dongxue Zhang  4 , Juliette Hong  1 , Lu Tian  5 , Sean C Mackey  1
Affiliations
Randomized Controlled Trial

Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial

Beth D Darnall et al. JAMA Netw Open. .

Erratum in

Abstract

Importance: Chronic low back pain (CLBP), the most prevalent chronic pain condition, imparts substantial disability and discomfort. Cognitive behavioral therapy (CBT) reduces the effect of CLBP, but access is limited.

Objective: To determine whether a single class in evidence-based pain management skills (empowered relief) is noninferior to 8-session CBT and superior to health education at 3 months after treatment for improving pain catastrophizing, pain intensity, pain interference, and other secondary outcomes.

Design, setting, and participants: This 3-arm randomized clinical trial collected data from May 24, 2017, to March 3, 2020. Participants included individuals in the community with self-reported CLBP for 6 months or more and an average pain intensity of at least 4 (range, 0-10, with 10 indicating worst pain imaginable). Data were analyzed using intention-to-treat and per-protocol approaches.

Interventions: Participants were randomized to (1) empowered relief, (2) health education (matched to empowered relief for duration and format), or (3) 8-session CBT. Self-reported data were collected at baseline, before treatment, and at posttreatment months 1, 2, and 3.

Main outcomes and measures: Group differences in Pain Catastrophizing Scale scores and secondary outcomes at month 3 after treatment. Pain intensity and pain interference were priority secondary outcomes.

Results: A total of 263 participants were included in the analysis (131 women [49.8%], 130 men [49.4%], and 2 other [0.8%]; mean [SD] age, 47.9 [13.8] years) and were randomized into 3 groups: empowered relief (n = 87), CBT (n = 88), and health education (n = 88). Empowered relief was noninferior to CBT for pain catastrophizing scores at 3 months (difference from CBT, 1.39 [97.5% CI, -∞ to 4.24]). Empowered relief and CBT were superior to health education for pain catastrophizing scores (empowered relief difference from health education, -5.90 [95% CI, -8.78 to -3.01; P < .001]; CBT difference from health education, -7.29 [95% CI, -10.20 to -4.38; P < .001]). Pain catastrophizing score reductions for empowered relief and CBT at 3 months after treatment were clinically meaningful (empowered relief, -9.12 [95% CI, -11.6 to -6.67; P < .001]; CBT, -10.94 [95% CI, -13.6 to -8.32; P < .001]; health education, -4.60 [95% CI, -7.18 to -2.01; P = .001]). Between-group comparisons for pain catastrophizing at months 1 to 3 were adjusted for baseline pain catastrophizing scores and used intention-to-treat analysis. Empowered relief was noninferior to CBT for pain intensity and pain interference (priority secondary outcomes), sleep disturbance, pain bothersomeness, pain behavior, depression, and anxiety. Empowered relief was inferior to CBT for physical function.

Conclusions and relevance: Among adults with CLBP, a single-session pain management class resulted in clinically significant improvements in pain catastrophizing, pain intensity, pain interference, and other secondary outcomes that were noninferior to 8-session CBT at 3 months.

Trial registration: ClinicalTrials.gov Identifier: NCT03167086.

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Conflict of interest statement

Conflict of Interest Disclosures: Stanford University receives revenue for empowered relief continuing medical education and instructor certification training provided to clinicians. Dr Darnall reported receiving personal fees as chief science advisor at AppliedVR unrelated to the current research; receiving royalties for 4 pain treatment books she has authored or coauthored; being principal investigator for a pain research award from the Patient-Centered Outcomes Research Institute (PCORI); receiving consultant fees from Axial Healthcare related to physician education for opioid prescribing and deprescribing, unrelated to the current work; serving on the board of directors for the American Academy of Pain Medicine and Institute for Brain Potential; being a scientific member of the NIH (National Institutes of Health) Interagency Pain Research Coordinating Committee, the Centers for Disease Control and Prevention Opioid Workgroup, and the Pain Advisory Group of the American Psychological Association; and being principal investigator for another NIH research award. Mr Keane reported receiving grant support from the NIH during the conduct of the study. Dr Mackey reported receiving research funding from the NIH, US Food and Drug Administration, and PCORI (administered through Stanford University); and being an unpaid advisor to ACCTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) on their oversight committee. Dr Cook reported receiving personal fees for consulting for the National Center for Complementary and Integrative Health (NCCIH) during the conduct of the study. Dr Lorig reported receiving grant funding from Stanford University School of Medicine as part of the grant that funded the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Participant Flow
CBT indicates cognitive behavioral therapy; CONSORT, Consolidated Standards of Reporting Trials; ER, empowered relief; HE, health education; ITT, intention to treat; MINI, Mini-International Neuropsychiatric Interview; NPRS, Numeric Pain Rating Scale. aBased on online eligibility screen.
Figure 2.
Figure 2.. Difference in Pain Catastrophizing Scale (PCS) Score Over Time
CBT indicates cognitive behavioral therapy; ER, empowered relief. Gray band displays the noninferiority margin.
See this image and copyright information in PMC

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