Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial

PainSci » bibliography » Ashar et al 2022
updated Jun 23, 2022

Tags: treatment, mind, back pain, pain problems, spine

Five pages on PainSci cite Ashar 2022: 1. The Complete Guide to Low Back Pain 2. Cognitive Behavioural Therapy for Chronic Pain 3. Cognitive behavioural therapy for low back pain (Member Post) 4. Jedi pain tricks, listed and classified: the taxonomy of mind-over-pain treatment (Member Post) 5. That Pain Reprocessing Therapy study is way too good to be true

PainSci notes on Ashar 2022:

This is a shiny paper in a fine journal with a suspiciously amazing result for “Pain Reprocessing Therapy” for back pain. A paper like this is a huge win for a branded mind-over-pain modality, but I urge people not to take these results at face value. The authors have very strong conflicts of interest, there are serious methodological flaws, and the results are deep in too-good-to-be-true territory. The only way I trust this result is when it has been replicated a couple times by researchers without quite so much skin in the game. For a more detailed analysis, especially a closer look at the COIs, see my June 10, 2022, blog post: “That Pain Reprocessing Therapy study is way too good to be true.”

Common issues and characteristics relevant to this paper: ?Scientific papers have many common characteristics, flaws, and limitations, and many of these are rarely or never acknowledged in the paper itself, or even by other reviewers. I have reviewed thousands of papers, and described many of these issues literally hundreds of times. Eventually I got sick of repeating myself, and so now I just refer to a list common characteristics, especially flaws. Not every single one of them applies perfectly to every paper, but if something is listed here, it is relevant in some way. Note that in the case of reviews, the issue may apply to the science being reviewed, and not the review itself.

A high (and possibly unacknowledged) risk of bias and its consequences (p-hacking, etc).

original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

IMPORTANCE: Chronic back pain (CBP) is a leading cause of disability, and treatment is often ineffective. Approximately 85% of cases are primary CBP, for which peripheral etiology cannot be identified, and maintenance factors include fear, avoidance, and beliefs that pain indicates injury.

OBJECTIVE: To test whether a psychological treatment (pain reprocessing therapy [PRT]) aiming to shift patients' beliefs about the causes and threat value of pain provides substantial and durable pain relief from primary CBP and to investigate treatment mechanisms.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial with longitudinal functional magnetic resonance imaging (fMRI) and 1-year follow-up assessment was conducted in a university research setting from November 2017 to August 2018, with 1-year follow-up completed by November 2019. Clinical and fMRI data were analyzed from January 2019 to August 2020. The study compared PRT with an open-label placebo treatment and with usual care in a community sample.

INTERVENTIONS: Participants randomized to PRT participated in 1 telehealth session with a physician and 8 psychological treatment sessions over 4 weeks. Treatment aimed to help patients reconceptualize their pain as due to nondangerous brain activity rather than peripheral tissue injury, using a combination of cognitive, somatic, and exposure-based techniques. Participants randomized to placebo received an open-label subcutaneous saline injection in the back; participants randomized to usual care continued their routine, ongoing care.

MAIN OUTCOMES AND MEASURES: One-week mean back pain intensity score (0 to 10) at posttreatment, pain beliefs, and fMRI measures of evoked pain and resting connectivity.

RESULTS: At baseline, 151 adults (54% female; mean [SD] age, 41.1 [15.6] years) reported mean (SD) pain of low to moderate severity (mean [SD] pain intensity, 4.10 [1.26] of 10; mean [SD] disability, 23.34 [10.12] of 100) and mean (SD) pain duration of 10.0 (8.9) years. Large group differences in pain were observed at posttreatment, with a mean (SD) pain score of 1.18 (1.24) in the PRT group, 2.84 (1.64) in the placebo group, and 3.13 (1.45) in the usual care group. Hedges g was -1.14 for PRT vs placebo and -1.74 for PRT vs usual care (P<.001). Of 151 total participants, 33 of 50 participants (66%) randomized to PRT were pain-free or nearly pain-free at posttreatment (reporting a pain intensity score of 0 or 1 of 10), compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care. Treatment effects were maintained at 1-year follow-up, with a mean (SD) pain score of 1.51 (1.59) in the PRT group, 2.79 (1.78) in the placebo group, and 3.00 (1.77) in the usual care group. Hedges g was -0.70 for PRT vs placebo (P=.001) and -1.05 for PRT vs usual care (P<.001) at 1-year follow-up. Longitudinal fMRI showed (1) reduced responses to evoked back pain in the anterior midcingulate and the anterior prefrontal cortex for PRT vs placebo; (2) reduced responses in the anterior insula for PRT vs usual care; (3) increased resting connectivity from the anterior prefrontal cortex and the anterior insula to the primary somatosensory cortex for PRT vs both control groups; and (4) increased connectivity from the anterior midcingulate to the precuneus for PRT vs usual care.

CONCLUSIONS AND RELEVANCE: Psychological treatment centered on changing patients' beliefs about the causes and threat value of pain may provide substantial and durable pain relief for people with CBP.

Trial Registration: ClinicalTrials.gov Identifier: NCT03294148.

original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

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