PRT for Chronic Low Back Pain

Pain Reprocessing Therapy for Chronic Low Back Pain: A Pilot Randomized Controlled 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.

Chronic low back pain (CLBP) is a prevalent and often debilitating condition that can impact daily functioning, occupational performance, and overall quality of life. In approximately 90% of individuals, CLBP persists in the absence of identifiable structural pathology and is thought to be related to altered processing of pain within the nervous system. As a result, there is a need for innovative, non-invasive treatment approaches that address these underlying mechanisms and move beyond traditional biomedical models of care.

This single-centre pilot study will evaluate Pain Reprocessing Therapy (PRT), a psychological intervention designed to modify maladaptive pain perceptions by targeting central pain processing and reducing fear associated with pain. The primary objective of this study is to assess the feasibility, acceptability, and preliminary effectiveness of PRT in individuals with chronic low back pain, while also evaluating recruitment, retention, and adherence to the intervention.

A total of 30 adults will be recruited and randomized to one of two groups. The intervention group will receive eight weekly sessions of PRT, while the control group (Monitoring and Education) will participate in a structured program consisting of health education and physical activity monitoring. Participants will complete validated questionnaires and physical and sensory assessments measuring pain intensity, functional status, mood, sleep, and physical performance at baseline, post-intervention, and at a three-month follow-up. Objective activity data will also be collected using wearable monitors throughout the eight week intervention period.

The results of this study will provide important preliminary data regarding the feasibility and potential clinical benefit of PRT and will inform the design of future larger-scale trials aimed at improving the management of chronic low back pain using PRT.

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