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RECRUITING Not applicable ClinicalTrials.gov

PRT for Chronic Low Back Pain

Sponsor: University Health Network, Toronto • ClinicalTrials.gov ID: NCT07696741

Registry updated: 2026-10-06
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Description

The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) is a feasible and acceptable treatment to complete for working-age adults (ages 18-65) with chronic low back pain. The main questions it aims to answer are: Is PRT acceptable and feasible for people with chronic low back pain to complete? Does PRT help reduce pain intensity and interference, while improving functional outcomes in people with chronic low back pain? Researchers will compare PRT to a Monitoring and Education Program to see whether participants who receive PRT experience greater improvements in pain, daily functioning, and well-being. Participants will: * Be randomly assigned to the PRT group or the Monitoring and Education group * Participate in 8 intervention sessions over an 8-week period * Wear an activity monitor for 8 weeks * Attend a follow-up assessment after completing the intervention and another assessment 3 months later Please note that ClinicalTrials.gov will be used solely as a public study registry and not as a participant recruitment tool. The study team will not recruit participants or accept self-referrals through ClinicalTrials.gov. All participant recruitment will occur only through the Research Ethics Board (REB) approved recruitment methods.

Interventions

  • Pain Reprocessing Therapy (Behavioral)
    Participants assigned to this arm will receive PRT, a psychological intervention designed to help individuals understand and manage their chronic pain by addressing how the brain and nervous system process pain signals. Participants will attend 8 weekly sessions over an 8-week period. The intervention includes, pain neuroscience education, somatic tracking exercises, and strategies to reduce fear and avoidance related to pain. In addition to the intervention, participants will complete study assessments and wear an activity monitor to measure physical activity and sleep patterns.
  • Monitoring and Education (Other)
    Participants assigned to this arm will receive a structured Monitoring and Education program delivered over 8 weekly sessions. This program was developed as a research comparison intervention. Participants will receive education related to physical activity, healthy lifestyle habits, sleep, stress management, and chronic pain self-management through Pain BC's LivePlanBe+ modules, while also reviewing information collected through activity monitoring devices. Participants will complete study assessments and wear an activity monitor to measure physical activity and sleep patterns throughout the study. This arm allows researchers to compare outcomes between participants receiving PRT and those receiving education and monitoring.

Eligibility criteria

Inclusion Criteria: * Working age adults (18-65) * Male or Female at birth * Persisting back pain for at least 3 months occurring at least half of the days in the past 6 months * Pain score of at least 4/10 (on a 10-point rating scale) * Ability to speak and understand English in order to follow study procedures and engage in study interventions. Exclusion Criteria: * Compensation seeking claim/litigation/WSIB claim * Severe active psychiatric disorders (e.g., psychosis, substance use disorder) * An active medical issue such as untreated inflammatory disorder (e.g. ankylosing spondylitis, psoriatic arthritis) * Active cancers affecting the spine or body * Unexplained unintended weight loss of 20 lbs. or more in the past year * Inability to control bowel or bladder, function * Individuals who have received or are currently receiving one-on-one or group psychotherapy for chronic low back pain within the past 2 years (e.g., mindfulness, meditation, cognitive behavioural therapy, acceptance and commitment therapy, pain reprocessing therapy, or emotional awareness and exposure therapy). * Logistical or technical barriers (e.g. transportation challenges, scheduling constraints, or difficulty using fitness trackers

Conditions

Chronic Low Back Pain (CLBP) Nociplastic Pain

Locations

  • Toronto Rehabilitation Institute - University Centre — Toronto, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record