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

Educational 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 chronic back pain and to investigate treatment mechanisms.
1 Credit CME
Key Points

Question  Can a psychological treatment based on the reappraisal of primary chronic back pain as due to nondangerous central nervous system processes provide substantial and durable pain relief?

Findings  In this randomized clinical trial, 33 of 50 participants (66%) randomized to 4 weeks of pain reprocessing therapy were pain-free or nearly pain-free at posttreatment, compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care, with gains largely maintained through 1-year follow-up. Treatment effects on pain were mediated by reduced beliefs that pain indicates tissue damage, and longitudinal functional magnetic resonance imaging showed reduced prefrontal responses to evoked back pain and increased resting prefrontal-somatosensory connectivity in patients randomized to treatment relative to patients randomized to placebo or usual care.

Meaning  Psychological treatment focused on changing beliefs about the causes and threat value of primary chronic back pain may provide substantial and durable pain relief.

Abstract

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.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: July 27, 2021.

Published Online: September 29, 2021. doi:10.1001/jamapsychiatry.2021.2669

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Ashar YK et al. JAMA Psychiatry.

Corresponding Author: Tor D. Wager, PhD, Department of Psychological and Brain Sciences, Dartmouth College, 352 Moore Hall, HB 6207, Hanover, New Hampshire 03755 (tor.d.wager@dartmouth.edu); Yoni K. Ashar, PhD, Department of Psychiatry, Weill Cornell Medical College, 1300 York Ave, New York, NY 10065 (yoniashar@gmail.com).

Author Contributions: Drs Ashar and Wager had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Ashar, Gordon, Schubiner, Uipi, Knight, Geuter, Dimidjian, Wager.

Acquisition, analysis, or interpretation of data: Ashar, Gordon, Schubiner, Uipi, Knight, Anderson, Carlisle, Polisky, Geuter, Flood, Kragel, Lumley, Wager.

Drafting of the manuscript: Ashar, Gordon, Schubiner, Polisky, Lumley, Wager.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Ashar, Polisky, Geuter, Lumley, Wager.

Obtained funding: Gordon, Schubiner, Flood, Wager.

Administrative, technical, or material support: Ashar, Uipi, Knight, Anderson, Carlisle, Polisky, Kragel, Dimidjian, Lumley, Wager.

Supervision: Ashar, Gordon, Wager.

Conflict of Interest Disclosures: Dr Ashar reports grants from the National Institutes of Health during the conduct of the study and personal fees from UnitedHealth Group, Lin Health, Inc, Pain Reprocessing Therapy Center, Inc, and Mental Health Partners of Boulder County outside the submitted work. Mr Gordon is a consultant with UnitedHealth Group, director of the Pain Psychology Center and the Pain Reprocessing Therapy Center, and is the author of the book The Way Out. Dr Schubiner is the co-owner of Freedom From Chronic Pain, Inc, earns book royalties for Unlearn Your Pain, Unlearn Your Anxiety and Depression and Hidden From View; serves as a consultant with UnitedHealth Group, Karuna Labs, and Curable Health; and receives personal fees from OVID Dx outside the submitted work. Mrs Uipi serves as a consultant for UnitedHealth Group. Dr Dimidjian reports being a co-founder of Mindful Noggin, Inc, and received royalties from Guilford Press and Wolters Kluwer as well as funding from The National Institutes of Health. Dr Lumley reports personal fees from CognifiSense, Inc, outside the submitted work. Dr Wager reports grants from the National Institutes of Health and the Foundation for the Study of the Therapeutic Encounter, and funding to support trainees from the Radiological Society of North America and the German Research Foundation; he is on the Scientific Advisory Board of Curable Health. No other disclosures were reported.

Funding and Support: This study was funded by National Institutes of Health grants R01 DA035484 (Dr Wager), R01 MH076136 (Dr Wager), National Center for Advancing Translational Sciences grant TL1-TR-002386 (Dr Ashar), Radiological Society of North America (Dr Flood), German Research Foundation grant GE 2774/1-1 (Dr Geuter), the Psychophysiologic Disorders Association, the Foundation for the Study of the Therapeutic Encounter, and community donations.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Information: Deidentified demographic and clinical outcomes data and subject-level functional magnetic resonance imaging statistical parameter maps for evoked pain and seed connectivity are provided here: https://figshare.com/s/1840dc4c0e236a7072ca

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