PRT for Chronic Low Back Pain

NCT07696741 | Recruiting

• 2 other identifiers: PRTforCLBPFURL2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain (CLBP); Nociplastic Pain

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Recruitment feasibility will be assessed by the proportion of eligible participants who consent to participate in the study out of all individuals screened for eligibility.

  Through study completion, an average of 1 year

• Participant Retention Rate

  Retention feasibility will be assessed by the proportion of randomized participants who complete the 3-month follow-up assessment (final study event).

  Baseline to 3-month follow-up

• Intervention Adherence

  Treatment adherence will be assessed by the number of intervention sessions attended by participants. Participants may attend up to 8 intervention sessions.

  During the 8-week intervention period

• Participant Satisfaction with the Intervention

  Participant satisfaction will be assessed using a post-intervention satisfaction survey evaluating participants' overall experience with the intervention. The questionnaire includes items assessing satisfaction, engagement, and perceived experience of the intervention they were assigned to. Response options use Likert-type scales, including: (1) frequency-based items rated as Always, Usually, Rarely, and (2) agreement-based items rated as Agree, Neutral, Disagree. Both scale options will be combined when assessed to report overall participant satisfaction. For scoring purposes, responses will be coded numerically (e.g., Always/Agree = 3, Usually/Neutral = 2, Rarely/Disagree = 1), with higher total scores indicating greater satisfaction and acceptability of the intervention.

  Immediately after the final intervention session, up to 8-week

• Participant Acceptability of the Intervention

  Acceptability of the intervention will be explored through a qualitative interview conducted with a randomly selected subset of 8 participants from the Pain Reprocessing Therapy (PRT) intervention group. Interviews will explore participants' overall impressions of the intervention, level of engagement, perceived benefits and limitations, barriers to participation, and suggestions for improvement. Interviews will be transcribed verbatim, and analyzed using qualitative analysis to identify key patterns and themes related to intervention acceptability.

  Immediately after the final intervention session, up to 8-week

Secondary Outcomes (14)

• Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS)

  Baseline, post-intervention (8 weeks), and 3-month follow-up.

• Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI)

  Baseline, post-intervention (8 weeks), and 3-month follow-up.

• Change From Baseline in Perceived Cause of Pain Measured by a Qualitative self-Report Question

  Baseline, post-intervention (8 weeks), and 3-month follow-up.

• Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ)

  Baseline, post-intervention (8 weeks), and 3-month follow-up.

• Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, post-intervention (8 weeks), and 3-month follow-up.

Study Arms (2)

Control Arm - Monitoring and Education

ACTIVE COMPARATOR

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.

Other: Monitoring and Education

Treatment Arm - Pain Reprocessing Therapy

EXPERIMENTAL

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

Behavioral: Pain Reprocessing Therapy

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.

Treatment Arm - Pain Reprocessing Therapy

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.

Control Arm - Monitoring and Education

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Workplace Safety and Insurance Board: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

Toronto Rehabilitation Institute - University Centre

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Nociplastic Pain; Chronic Pain; Back Pain; Agnosia; Low Back Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Andrea D Furlan, MD PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Hasan

CONTACT

+1 416-597-3422; Mariam.hasan@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants will be randomly assigned to one of two study arms: PRT or Monitoring and Education. Outcomes will be compared between groups to evaluate the feasibility, acceptability, and effectiveness of PRT for chronic low back pain.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)