By Ellen Feldman, MD
Altru Health System, Grand Forks, ND
Summary Points
- In this three-arm clinical trial, 263 adults with chronic low back pain were randomly assigned to one of three groups: a single session of evidence-based pain management skills (“Empowered Relief”), an eight-session course of cognitive behavioral therapy (CBT), or a control group receiving one session of health education.
- After three months, participants who received Empowered Relief exhibited clinically meaningful improvements in pain catastrophizing, pain intensity, and pain interference that were on par with the participants in the CBT arm. Both of these groups showed statistically significant improvement in these measures compared to the health education area.
- While Empowered Relief proved to be comparable to CBT in various measures, it was found to be less effective in improving physical function when compared to the CBT group.
SYNOPSIS: This randomized clinical trial involving adults with chronic low back pain demonstrates that a single session of a pain management class, when compared to a full course of cognitive behavioral therapy, yields noninferior (clinically on par) outcomes in pain catastrophizing and several other measures at the three-month follow-up.
SOURCE: Darnall BD, Roy A, Chen AL, et al. 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. JAMA Netw Open 2021;4:e2113401.
In the field of medicine, pain frequently takes center stage. Nowhere is this more evident than in patients grappling with chronic low back pain, one of the most prevalent chronic pain conditions.1
A 2018 expert review underscores that effective management of chronic low back pain often includes psychological therapy, such as cognitive behavioral therapy (CBT).2 CBT, a form of talk therapy, typically involves eight to 12 group sessions.3 Research has revealed that decreased pain catastrophizing, a phenomenon associated with the onset of chronic low back pain, plays a pivotal role in the treatment response to CBT. Pain catastrophizing typically involves focusing on pain and feeling helpless; CBT helps patients change this type of thinking.4
Unfortunately, despite the proven effectiveness of CBT, the use of this modality remains restricted because of factors such as limited availability and cost constraints.2,3
Searching for a less resource-intensive and more widely accessible treatment option, Darnall et al developed a two-hour, single-session class known as “Empowered Relief.” This innovative approach incorporated elements from CBT (such as principles of self-regulation) while also integrating mindfulness instruction and educational components.
Encouraging preliminary results prompted Darnall et al to design a three-armed trial to compare the efficacy of Empowered Relief to traditional CBT, with both interventions being benchmarked against a two-hour general health educational session.
The study, conducted between 2017 and 2020, recruited participants from the community who had documented chronic low back pain, an average pain intensity score of at least 4 out of 10, and a moderate or higher average pain catastrophizing score.
Exclusion criteria included patients with severe depression, substance use, significant cognitive impairments and recent exposure to Empowered Relief or CBT.
The study enrolled 263 individuals, achieving nearly equal representation of both genders. Most of the participants were white, non-Hispanic, married, and highly educated. Randomization placed all participants into one of the three specified treatment arms: Empowered Relief, CBT, or health education.
Results
In this study, Darnall et al pursued a noninferiority trial. It is important to understand that noninferiority trials differ from standard efficacy trials; these are not primarily concerned about whether one treatment is statistically significantly worse or better than an established treatment. Instead, these trials focus on whether the efficacy gap between the new treatment and the standard of care is narrow enough to be clinically acceptable.5
Noninferiority trials thus necessitate the establishment of a predetermined noninferior margin before the study begins. This margin acts as a predefined benchmark to evaluate if the novel intervention is acceptably close in effectiveness to an existing treatment.
For this study, the noninferiority margin was calculated as 4.3. In practical terms, for Empowered Relief to be considered noninferior to CBT in terms of reducing pain catastrophizing, the average decrease in pain catastrophizing scores for participants in the Empowered Relief group needed to fall within 4.3 points of the average drop in these same scores for the participants receiving CBT.
This margin is not just a statistical measure, but a clinically determined threshold that signifies the maximum acceptable difference in treatment effectiveness for the new intervention to be considered a viable alternative.5
Table 1 displays results at three months post-intervention for the three groups of participants with chronic low back pain.
Table 1. Results of Pain Catastrophizing Scores at Baseline and Month 3 for Each Arm of the Study |
|||
| Empowered Relief (n = 78) |
CBT (n = 76) |
Health Education (n = 69) |
|
Baseline mean score (SD) |
1.00 |
0.98 (0.96-1.00) |
1.05 (1.03-1.06) |
Month 3 mean score (SD) |
1.00 |
0.99 (0.97-1.01) |
1.03 (1.01-1.05) |
CBT: cognitive behavioral therapy; SD: standard deviation |
|||
The primary outcome measured was improvement on the Pain Catastrophizing Scale, a 13-item questionnaire that asks patients to report emotional and cognitive responses to pain on a scale from 0 (not at all) to 4 (always).6
Table 2 displays between group differences at three months and corresponding P values.
Table 2. Between-Group Differences in Pain Catastrophizing Scale Scores at Month 3 |
|||
| Empowered Relief vs. Health Education (95% CI) |
CBT vs. Health Education (95% CI) |
Empowered Relief vs. CBT (95% CI) |
|
Pain catastrophizing scores (negative value = decrease in score) |
-5.90 (-8.78 to -3.01) P < 0.001* |
-7.29 (-10.2 to -4.38) P < 0.001* |
1.39 (0 to 4.24) P = 0.34 |
*Statistically significant value CBT: cognitive behavioral therapy; CI: confidence interval |
|||
Multiple secondary outcomes were measured, including pain intensity, pain interference, generalized fatigue, and anxiety. In all cases, participants from the CBT group and from the Empowered Relief group showed statistically significant improvement in these measures when compared with the control group (health education.) In addition, participants from the Empowered Relief group scored within the noninferiority margin at month 3 for these measures when compared with participants from the CBT group.
However, when measuring self-reported physical functioning, participants from the Empowered Relief group showed significantly less improvement than those in the CBT arm of the study, and the results were not significantly different from the health education group. On the other hand, the CBT group showed significant improvement in this area compared to the two other groups. (See Table 3.)
Table 3. Between-Group Differences in Self-Reported Physical Function at Three Months |
|||
| Empowered Relief vs. Health Education (95% CI) |
CBT vs. Health Education (95% CI) |
Empowered Relief vs. CBT (95% CI) |
|
Self-reported physical function (higher scores indicate improved function) |
1.83 (0.28 to 3.39) P = 0.02 |
3.36(1.78 to 4.94) P < 0.001* |
-1.53 (-3.06 to 0) P = 0.05 |
*Statistically significant value CBT: cognitive behavioral therapy; CI: confidence interval |
|||
Commentary
Darnall et al bring a new player to the challenging field of pain management strategies for chronic low back pain. The Empowered Relief program, a concise, two-hour, single-session class that combines elements of CBT, mindfulness, and education has been integrated into treatment protocols at Stanford University since 2013.7 While ongoing research is needed (and is planned, according to the Stanford website) the results of this clinical trial were quite promising and point to efficacy in treatment of chronic low back pain on par with CBT for most outcomes. One area where the study might benefit from expansion is in the diversity of its participant pool. Since the publication of their 2021 study, Empowered Relief has been adopted by several U.S. institutions and international healthcare facilities and has attracted funded research from the National Institutes of Health.7
Future studies are likely to include a more diverse range of patients across various racial, socioeconomic, and geographic backgrounds, providing a broader perspective on its efficacy. Furthermore, extending the follow-up period beyond three months could provide more insights into the long-term effectiveness of Empowered Relief and help determine whether occasional refresher classes or “booster” sessions are necessary. In parallel, investigating the potential of online delivery of Empowered Relief, especially considering the promising results of online-delivered CBT for pain management, would be a significant step forward toward the goal of increasing accessibility of this intervention.8
While the study showcases the effectiveness of Empowered Relief in managing chronic low back pain comparable to an eight-session course of CBT in reducing pain catastrophizing, pain intensity, and pain interference, it also highlights a limitation. Empowered Relief was found to be less effective than CBT in improving physical function. This may be a crucial consideration for clinicians, as functional improvement often is a key objective in treating chronic low back pain.
This gap in efficacy suggests that while Empowered Relief is a valuable tool for managing certain aspects of chronic low back pain, especially in settings where resources for prolonged CBT are limited, it may need to be supplemented with other interventions focused on physical rehabilitation and functional improvement. The key may be to integrate Empowered Relief into a broader, multidisciplinary approach in the treatment of chronic low back pain, including physical therapy and other functional improvement strategies.
For integrative providers, this study emphasizes the value of personalized treatment plans for chronic low back pain, considering not only the clinical aspects but also the individual patient’s circumstances and preferences. It highlights the evolving landscape of pain management and the importance of adaptable, multifaceted approaches to treating chronic conditions.
References
- Williamson OD, Cameron P. The global burden of low back pain. International Association for the Study of Pain. Published July 9, 2021. https://www.iasp-pain.org/resources/fact-sheets/the-global-burden-of-low-back-pain/
- Foster NE, Anema JR, Cherkin D; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: Evidence, challenges, and promising directions. Lancet 2018;391:2368-2383.
- Mindouri A-S, Trevlaki E, Trevlakis E, et al. The effectiveness of cognitive behavioral therapy in chronic low back pain. BJSTR 2023;48:39646-39655.
- Gilliam WP, Schumann ME, Cunningham JL, et al. Pain catastrophizing as a treatment process variable in cognitive behavioural therapy for adults with chronic pain. Eur J Pain 2021;25:339-347.
- Snapinn SM. Noninferiority trials. Curr Control Trials Cardiovasc Med 2000;1:19-21.
- Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532.
- Stanford University. Empowered Relief. https://empoweredrelief.stanford.edu/about
- Terpstra JA, van der Vaart R, van Beugen S, et al. Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. Internet Interv 2022;30:100587.
This randomized clinical trial involving adults with chronic low back pain demonstrates that a single session of a pain management class, when compared to a full course of cognitive behavioral therapy, yields noninferior (clinically on par) outcomes in pain catastrophizing and several other measures at the three-month follow-up.
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