Rewiring Chronic Pain

NCT07724808 | Not Yet Recruiting DMC

• 1 other identifier: SOR-26-0181
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effectiveness of a brief psychological intervention for chronic pain treatment, as well as the psychological and neurophysiological mechanisms associated with changes in pain intensity. Participants with chronic pain will be randomly assigned to one of three groups: two types of brief psychological interventions and a treatment-as-usual control group. Throughout the study, participants will attend a series of therapeutic sessions, complete questionnaires, undergo brain measurements (EEG and MRI), and participate in physiological monitoring using a smartwatch. The study aims to investigate which cognitive and physiological changes occur during the intervention, and whether early markers can be identified that may predict improvement in pain following this type of treatment. In addition, differences between cognitive and somatic components of the intervention will be examined to better understand which elements contribute to clinical change, and to determine whether knowledge alone is sufficient or whether participants must undergo a bodily experience in order to produce changes in pain levels. The goal of the study is to improve understanding of the mechanisms underlying chronic pain and responses to psychological treatments, and to contribute to the development of more personalized, effective treatments with minimal side effects in the future.

Conditions

Full PRT; Partial PRT (Non Somtic); Treatment as Usual

Keywords

chronic pain; resting-state fMRI; Pain Reprocessing Therapy (PRT); naturalistic neuroimaging; Network Based Statistic (NBS); functional connectivity; fMRI

Outcome Measures

Primary Outcomes (1)

• Average pain intensity in the first week post-treatment

  Participants will be prompted twice daily via the Labfront app, connected to their wearable, to respond to the following single item from the Brief Pain Inventory (BPI): "Please rate your pain by circling the one number that tells how much pain you have right now," rated on a 0-10 numeric scale (0 = "No pain"; 10 = "Pain as bad as you can imagine"). Prompts will be delivered during 6 weeks, where the primary outcome will be the mean of all valid responses collected during the first week post-treatment.

  Twice a day for 6 weeks

Secondary Outcomes (13)

• Pain severity: pre- to post-treatment score difference

  4 weeks of treatment

• Pain interference: pre- to post-treatment score difference

  4 weeks of treatment

• Pain levels (0-10) at up to 6 months follow-up

  Up to 6 months post-treatment

• Anxiety levels: pre- to post-treatment difference

  4 weeks of treatment

• Depression levels: pre- to post-treatment difference

  4 weeks of treatment

Study Arms (3)

Treatment as Usual

ACTIVE COMPARATOR

This arm includes receiving the TAU treatment in chronic pain (oral medications and/or physical therapy).

Other: TAU

Pain Reprocessing Therapy (PRT)

EXPERIMENTAL

In this condition, the participants will receive pain reprocessing therapy twice a week for four weeks (a total of 8 sessions). This treatment focuses on psychoeducation, cognitive restructuring and somatic elements.

Behavioral: Pain Reprocessing Therapy (PRT)

Partial PRT

EXPERIMENTAL

In this condition, participants will receive partial PRT, which includes psychoeducation and cognitive restructuring.

Behavioral: Pain Reprocessing Therapy (PRT)

Interventions

Pain Reprocessing Therapy (PRT) BEHAVIORAL

In this full PRT, the participants will receive pain reprocessing therapy twice a week for four weeks (a total of 8 sessions). This treatment focuses on psychoeducation, cognitive restructuring and somatic elements. In the Partial PRT, participants will receive the same intervention, but without the somatic element.

Also known as: PRT, Partial PRT

Pain Reprocessing Therapy (PRT); Partial PRT

TAU OTHER

Participants in this arm will receive treatment as usual.

Treatment as Usual

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-70 years
• Chronic pain lasting over 3 months, including chronic pain conditions such as fibromyalgia and complex regional pain syndrome (CRPS)
• Average pain intensity ≥4 on a 0-10 scale
• Stable medication regimen for at least 4 weeks prior to treatment initiation
• Hebrew language fluency
• Provision of informed consent, including consent for video recordings

You may not qualify if:

• Current participation in other pain-related psychotherapy
• Pregnancy
• Substance abuse, including deviations from prescribed medication use
• Change in medication or dosage in the 4 weeks preceding treatment
• Diagnosed active cancer
• Dementia
• Severe depression (BDI-II score \> 29)
• Moderate cognitive impairment based on the Montreal Cognitive Assessment (MoCA)
• Current or past diagnosis of schizophrenia, psychosis, bipolar disorder, multiple personality disorder, or dissociative identity disorder
• Inability to undergo MRI as determined by MRI safety screening (e.g., claustrophobia, metal in body such as vascular clips, pacemakers, or certain cochlear implants)

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead

Study Sites (1)

Ben-Gurion University of the Negev

Beersheba, Israel

Location

Related Publications (1)

• Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669.

  PMID: 34586357 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Or Duek, Ph.D

CONTACT

+972-507606547; ord@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The treatment-as-usual group knows they do not receive treatment, but the PRT and partial PRT groups will be masked (patients are naive to the PRT protocol, so they don't know which treatment they actually receive).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 10 months after the end of the study
• Access Criteria: IPD can be accessed upon request for specific research question

Locations

IL (1)