Recruiting

PRT vs. Monitoring

Sponsor:

University Health Network, Toronto

Code:

NCT07696741

Conditions

Chronic Low Back Pain (CLBP)

Nociplastic Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Pain Reprocessing Therapy

Monitoring and Education

Study Details

Brief summary:

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.

Conditions

Chronic Low Back Pain (CLBP)

Nociplastic Pain

Study ID

NCT07696741

Start date

Jul 15, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control Arm - Monitoring and Education

Participants will receive an 8-week monitoring and education program consisting of weekly sessions focused on pain education, symptom and activity level monitoring, and self-management strategies for chronic low back pain.

experimental: Treatment Arm - Pain Reprocessing Therapy

Participants will receive an 8-week Pain Reprocessing Therapy (PRT) program consisting of weekly therapist-led one-on-one sessions designed to reduce pain.

Interventions

Pain Reprocessing Therapy

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

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: Through study completion, an average of 1 year ]
  • Participant Retention Rate [ Time Frame: Baseline to 3-month follow-up ]
  • Intervention Adherence [ Time Frame: During the 8-week intervention period ]
  • Participant Satisfaction with the Intervention [ Time Frame: Immediately after the final intervention session, up to 8-week ]
  • Participant Acceptability of the Intervention [ Time Frame: Immediately after the final intervention session, up to 8-week ]

Central Contacts and Locations

Central contacts

Mariam Hasan

+1 416-597-3422Pain@uhn.ca

Andrea Furlan, MD

+1 416-597-3422Andrea.Furlan@uhn.ca

Locations

Toronto Rehabilitation Institute - University Centre

Recruiting

Toronto, Ontario, Canada, M5G 2A2

Contacts

Mariam Hasan

+1 416-579-3422Pain@uhn.ca

Andrea Furlan, MD

+1 416-579-3422Andrea.Furlan@uhn.ca

Principal Investigator:

Andrea Furlan, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 17, 2026

Last verified

Jul, 2026

Keywords

  • Chronic Pain
  • Back Pain
  • Nociplastic Pain
  • Pain Management
  • Randomized Controlled Trial
  • Mind-Body Therapies
  • Low Back Pain
  • Rehabilitation
  • Pilot Projects

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-17.