Chronic Low Back Pain (CLBP)NCT07696741
PRT for Chronic Low Back Pain
A study testing Pain Reprocessing Therapy and Monitoring and Education in people with Chronic Low Back Pain (CLBP) and Nociplastic Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Nociplastic Pain
- What is being tested?
- Pain Reprocessing Therapy and Monitoring and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute - University Centre
Toronto, Ontario, M5G 2A2
Roomi Masood, +1 416-579-3422 ext. 3823, Pain@uhn.ca
Andrea Furlan, MD, +1 416-579-3422 ext. 4607, Andrea.Furlan@uhn.ca
About this study
Official title: 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain (CLBP), Nociplastic Pain
- Being tested
- Pain Reprocessing Therapy, Monitoring and Education
- Keywords
- Chronic Pain, Back Pain, Nociplastic Pain, Pain Management, Randomized Controlled Trial, Mind-Body Therapies, Low Back Pain, Rehabilitation, Pilot Projects
- Medical subject headings
- Nociplastic Pain, Chronic Pain, Back Pain, Agnosia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing TherapyBehavioural
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pain Reprocessing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (8 weeks), and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Workplace Safety and Insurance Board
- Responsible party
- Principal investigator, Andrea D. Furlan, University Health Network, Toronto
- Investigators
- Andrea D Furlan, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696741
- Sponsor's protocol ID
- 25-6088
- Other IDs
- FURL2025
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared as this is a pilot feasibility study with a small sample size of 30 participants.
Publications
Hodges, P. W., & Costa, N. (2023). Low back pain fact sheet. International Association for the Study of Pain (IASP). https://www.iasp-pain.org/resources/fact-sheets/low-back-pain/ (accessed October 9, 2024).
Canadian Chiropractic Association (CCA). (2018, December 26). Canada's low back pain epidemic. https://www.chiropractic.ca/blog/canadas-low-back-pain-epidemic/ (accessed October 9, 2024)
WHO guideline for non-surgical management of chronic primary low back pain in adults in primary and community care settings [Internet]. Geneva: World Health Organization; 2023. Available from http://www.ncbi.nlm.nih.gov/books/NBK599212/
PubMed 38198579Sankar A, Davis AM, Palaganas MP, Beaton DE, Badley EM, Gignac MA. Return to work and workplace activity limitations following total hip or knee replacement. Osteoarthritis Cartilage. 2013 Oct;21(10):1485-93. doi: 10.1016/j.joca.2013.06.005. Epub 2013 Jun 15.
PubMed 23774473Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
PubMed 22029804Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
PubMed 19897823Paul DR, Kramer M, Moshfegh AJ, Baer DJ, Rumpler WV. Comparison of two different physical activity monitors. BMC Med Res Methodol. 2007 Jun 25;7:26. doi: 10.1186/1471-2288-7-26.
PubMed 17592631Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
PubMed 12890299Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
PubMed 6222486Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272