Chronic Low Back Pain (CLBP), Nociplastic Pain
Conditions
Keywords
Chronic Pain, Back Pain, Nociplastic Pain, Pain Management, Randomized Controlled Trial, Mind-Body Therapies, Low Back Pain, Rehabilitation, Pilot Projects
Brief 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. 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.
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.
Interventions
BEHAVIORALPain 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.
OTHERMonitoring 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 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.
Sponsors
University Health Network, Toronto
Workplace Safety and Insurance Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Through study completion, an average of 1 year | 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. |
| Participant Retention Rate | Baseline to 3-month follow-up | Retention feasibility will be assessed by the proportion of randomized participants who complete the 3-month follow-up assessment (final study event). |
| Intervention Adherence | During the 8-week intervention period | Treatment adherence will be assessed by the number of intervention sessions attended by participants. Participants may attend up to 8 intervention sessions. |
| Participant Satisfaction with the Intervention | Immediately after the final intervention session, up to 8-week | 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. |
| Participant Acceptability of the Intervention | Immediately after the final intervention session, up to 8-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Perceived Cause of Pain Measured by a Qualitative self-Report Question | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | The Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
| Change From Baseline in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
| Change From Baseline in Work-Related Outcomes Measure by Self-Reported Return-to-Work Rates | Baseline, post-intervention (8 weeks), and 3-month follow-up. | The work-related outcome question assesses self-reported return-to-work rates. |
| Change From Baseline in Physical Activity and Sleep Measured by Actigraphy | Baseline and throughout the 8-week intervention period. | 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. |
| Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT) | Baseline, post-intervention (8 weeks), and 3-month follow-up. | The Six-Minute Walk Test measures the distance a participant can walk in six minutes. Greater walking distance indicates better functional capacity. |
| Change From Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Pain Processing Measured by Pressure Pain Threshold | Baseline, post-intervention (8 weeks), and 3-month follow-up. | Pressure Pain Threshold assesses the minimum force applied to a stimulus that is perceived as painful. Higher thresholds indicate reduced pain sensitivity. |
| Change From Baseline in Central Sensitization Measured by Temporal Summation | Baseline, post-intervention (8 weeks), and 3-month follow-up. | 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. |
| Change From Baseline in Pain Response Measured by Wind-Up Using Weighted Pinprick Stimuli | Baseline, post-intervention (8 weeks), and 3-month follow-up. | Wind-up ratio assesses pain responses to single versus repeated weighted pinprick stimuli. A lower wind-up ratio indicates reduced central sensitization. |
Countries
Canada
Contacts
CONTACTMariam Hasan
CONTACTAndrea Furlan, MD
PRINCIPAL_INVESTIGATORAndrea D Furlan, MD PhD
University Health Network, Toronto
Outcome results
None listed