PRT for Chronic Low Back Pain

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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 ass
• Другое Monitoring and Education
  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 asse

Первичные конечные точки

• Recruitment Rate [Срок оценки: Through study completion, an average of 1 year]
• Participant Retention Rate [Срок оценки: Baseline to 3-month follow-up]
• Intervention Adherence [Срок оценки: During the 8-week intervention period]
• Participant Satisfaction with the Intervention [Срок оценки: Immediately after the final intervention session, up to 8-week]
• Participant Acceptability of the Intervention [Срок оценки: Immediately after the final intervention session, up to 8-week]

Вторичные конечные точки (12)

• Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]
• Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI) [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]
• Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ) [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]
• Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]
• Change From Baseline in Physical Activity and Sleep Measured by Actigraphy [Срок оценки: Baseline and throughout the 8-week intervention period.]
• Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT) [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]
• Change From Baseline in Pain Processing Measured by Pressure Pain Threshold [Срок оценки: Baseline, post-intervention (8 weeks), and 3-month follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• Toronto Rehabilitation Institute - University Centre — Toronto

Публикации

• 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/ PMID 38198579
• 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. PMID 23774473
• 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. PMID 22029804
• 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. PMID 19897823
• 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. PMID 17592631
• 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. PMID 1991946

Идентификаторы

NCT: NCT07696741 · PRTforCLBP · FURL2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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