Health TrialsbyHealthPanel

PRT for Chronic Low Back Pain

ConditionsChronic Low Back Pain (CLBP)Nociplastic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Control Arm - Monitoring and EducationActive comparator 1 intervention
Group B: Treatment Arm - Pain Reprocessing TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 1 year
2

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).

Time frame
Baseline to 3-month follow-up
3

Intervention Adherence

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

Time frame
During the 8-week intervention period
4

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.

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

Secondary outcomes

1

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

The Visual Analog Scale (VAS) measures pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

Time frame
Baseline, post-intervention (8 weeks), and 3-month follow-up.
2

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

The Brief Pain Inventory (BPI) assesses the extent to which pain interferes with daily activities, mood, sleep, work, and relationships. Participants rate each item using an 11-point numeric rating scale ranging from 0 to 10. A total interference score is calculated across items. Lower scores indicate less pain interference and higher scores indicate greater pain interference.

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

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

Perceived cause of pain will be assessed using a qualitative self-report question in which participants are asked to describe their beliefs about the cause(s) of their pain, providing up to three responses.

Time frame
Baseline, post-intervention (8 weeks), and 3-month follow-up.
4

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

The Roland-Morris Disability Questionnaire (RMDQ) assesses disability related to low back pain. Scores range from 0 to 24, with higher scores indicating greater disability.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Workplace Safety and Insurance Board

Collaborator

Source ClinicalTrials.gov
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