Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FURL2025 | Other Grant/Funding Number | Workplace Safety and Insurance Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Workplace Safety and Insurance Board | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-intervention (8 weeks), and 3-month follow-up. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam Hasan | Contact | +1 416-597-3422 | 3823 | Mariam.hasan@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andrea D Furlan, MD PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institute - University Centre | Toronto | Ontario | M5G 2A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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). | ||
| Background | 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) | ||
| 38198579 | Background | 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/ | |
| 23774473 |
Not provided
Not provided
IPD will not be shared as this is a pilot feasibility study with a small sample size of 30 participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000098653 | Nociplastic Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D000377 | Agnosia |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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. |
|
| Immediately after the final intervention session, up to 8-week |
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, post-intervention (8 weeks), and 3-month follow-up. |
| Background |
| Sankar 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. |
| 22029804 | Background | Moore 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. |
| 19897823 | Background | Faul 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. |
| 17592631 | Background | Paul 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. |
| 1991946 | Background | Podsiadlo 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. |
| 12890299 | Background | Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5. |
| 16717171 | Background | Spitzer 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. |
| 11556941 | Background | Kroenke 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. |
| 2748771 | Background | Buysse 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. |
| 6222486 | Background | Roland 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. |
| 8080219 | Background | Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. |
| 20053272 | Background | Thabane 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. |
| 37094744 | Background | Tankha H, Lumley MA, Gordon A, Schubiner H, Uipi C, Harris J, Wager TD, Ashar YK. "I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. J Pain. 2023 Sep;24(9):1582-1593. doi: 10.1016/j.jpain.2023.04.006. Epub 2023 Apr 23. |
| 34586357 | Background | Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669. |
| 37768666 | Background | Ashar YK, Lumley MA, Perlis RH, Liston C, Gunning FM, Wager TD. Reattribution to Mind-Brain Processes and Recovery From Chronic Back Pain: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333846. doi: 10.1001/jamanetworkopen.2023.33846. |
| 38310923 | Background | Nijs J, Kosek E, Chiarotto A, Cook C, Danneels LA, Fernandez-de-Las-Penas C, Hodges PW, Koes B, Louw A, Ostelo R, Scholten-Peeters GGM, Sterling M, Alkassabi O, Alsobayel H, Beales D, Bilika P, Clark JR, De Baets L, Demoulin C, de Zoete RMJ, Elma O, Gutke A, Hanafi R, Hotz Boendermaker S, Huysmans E, Kapreli E, Lundberg M, Malfliet A, Meziat Filho N, Reis FJJ, Voogt L, Zimney K, Smeets R, Morlion B, de Vlam K, George SZ. Nociceptive, neuropathic, or nociplastic low back pain? The low back pain phenotyping (BACPAP) consortium's international and multidisciplinary consensus recommendations. Lancet Rheumatol. 2024 Mar;6(3):e178-e188. doi: 10.1016/S2665-9913(23)00324-7. Epub 2024 Feb 1. |
| 33974577 | Background | Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available. |
| 24615305 | Background | Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, Konstantinou K, Main C, Somerville S, Sowden G, Wathall S, Young J, Hay EM; IMPaCT Back Study team. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014 Mar-Apr;12(2):102-11. doi: 10.1370/afm.1625. |
| 29971708 | Background | Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3. |
| 10470716 | Background | Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4. |
| 22641374 | Background | Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013 Jan;17(1):5-15. doi: 10.1002/j.1532-2149.2012.00170.x. Epub 2012 May 28. |
| 22586331 | Background | da C Menezes Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LO. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012 Aug 7;184(11):E613-24. doi: 10.1503/cmaj.111271. Epub 2012 May 14. |
| 17077742 | Background | Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2724-7. doi: 10.1097/01.brs.0000244618.06877.cd. |
| 15298484 | Background | Rapoport J, Jacobs P, Bell NR, Klarenbach S. Refining the measurement of the economic burden of chronic diseases in Canada. Chronic Dis Can. 2004 Winter;25(1):13-21. |
| 34062144 | Background | Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Nociplastic pain: towards an understanding of prevalent pain conditions. Lancet. 2021 May 29;397(10289):2098-2110. doi: 10.1016/S0140-6736(21)00392-5. |
| Background | Kaplan, W., Wirtz, V., Mantal Teeuwisse, A., Stolk, P., Duthey, B., & Laing, R. (2013). Priority medicines for Europe and the world: 2013 update. World Health Organization. https://www.who.int/medicines/areas/priority_medicines/en/ |
| 17909209 | Background | Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006. |
| 37273833 | Background | GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun. |
| 22184555 | Background | Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. doi: 10.1155/2011/876306. |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |