An interventional study of Pain Reprocessing Therapy and Monitoring and Education in Chronic Low Back Pain (CLBP) and Nociplastic Pain, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Other
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:
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.
20 studies on the registry are indexed under Nociplastic Pain; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 51 across 11 interventional studies indexed under Nociplastic Pain.
Browse Nociplastic Pain studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
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
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
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
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
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.
Time frame: Immediately after the final intervention session, up to 8-week
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.
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.
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.
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.
Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over the previous month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Work-Related Outcomes Measure by Self-Reported Return-to-Work Rates
The work-related outcome question assesses self-reported return-to-work rates.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Physical Activity and Sleep Measured by Actigraphy
Physical activity and sleep will be measured using a wearable activity monitor. Outcomes include daily step count, sedentary and non-sedentary time, calories, overall activity levels, as well as total sleep time and sleep efficiency. Higher values indicate greater physical activity and better sleep quality.
Time frame: Baseline and throughout the 8-week intervention period.
Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test measures the distance a participant can walk in six minutes. Greater walking distance indicates better functional capacity.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test
The Timed Up and Go test measures the time required to stand from a chair, walk a short distance, return, and sit down. Lower times indicate better functional mobility.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Pain Processing Measured by Pressure Pain Threshold
Pressure Pain Threshold assesses the minimum force applied to a stimulus that is perceived as painful. Higher thresholds indicate reduced pain sensitivity.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Central Sensitization Measured by Temporal Summation
Temporal Summation asses the increase in pain perception in response to repetitive stimuli of constant intensity. Lower temporal summation indicates reduced central nervous system sensitization.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Pain Response Measured by Wind-Up Using Weighted Pinprick Stimuli
Wind-up ratio assesses pain responses to single versus repeated weighted pinprick stimuli. A lower wind-up ratio indicates reduced central sensitization.
Time frame: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Plan to share: No — IPD will not be shared as this is a pilot feasibility study with a small sample size of 30 participants.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto