PRT for Chronic Low Back Pain
2026年8月14日 更新者：Andrea D. Furlan、University Health Network, Toronto
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?
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mariam Hasan
- 电话号码：3823 +1 416-597-3422
- 邮箱：Pain@uhn.ca
研究联系人备份
- 姓名：Andrea Furlan, MD
- 电话号码：4607 +1 416-597-3422
- 邮箱：Andrea.Furlan@uhn.ca
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 2A2
- 招聘中
- Toronto Rehabilitation Institute - University Centre
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接触：
- Andrea Furlan, MD
- 电话号码：4607 +1 416-579-3422
- 邮箱：Andrea.Furlan@uhn.ca
-
首席研究员：
- Andrea Furlan, MD
-
接触：
- Mariam Hasan
- 电话号码：3823 +1 416-579-3422
- 邮箱：Pain@uhn.ca
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Control Arm - Monitoring and Education
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.
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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.
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实验性的：Treatment Arm - Pain Reprocessing Therapy
Participants will receive an 8-week Pain Reprocessing Therapy (PRT) program consisting of weekly therapist-led one-on-one sessions designed to reduce pain.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment Rate
大体时间：Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Participant Retention Rate
大体时间：Baseline to 3-month follow-up
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Retention feasibility will be assessed by the proportion of randomized participants who complete the 3-month follow-up assessment (final study event).
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Baseline to 3-month follow-up
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Intervention Adherence
大体时间：During the 8-week intervention period
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Treatment adherence will be assessed by the number of intervention sessions attended by participants.
Participants may attend up to 8 intervention sessions.
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During the 8-week intervention period
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Participant Satisfaction with the Intervention
大体时间：Immediately after the final intervention session, up to 8-week
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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
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Participant Acceptability of the Intervention
大体时间：Immediately after the final intervention session, up to 8-week
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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. |
Immediately after the final intervention session, up to 8-week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Change From Baseline in Perceived Cause of Pain Measured by a Qualitative self-Report Question
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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The Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms.
Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7)
大体时间：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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Work-Related Outcomes Measure by Self-Reported Return-to-Work Rates
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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The work-related outcome question assesses self-reported return-to-work rates.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Physical Activity and Sleep Measured by Actigraphy
大体时间：Baseline and throughout the 8-week intervention period.
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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.
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Baseline and throughout the 8-week intervention period.
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Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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The Six-Minute Walk Test measures the distance a participant can walk in six minutes.
Greater walking distance indicates better functional capacity.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Pain Processing Measured by Pressure Pain Threshold
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Pressure Pain Threshold assesses the minimum force applied to a stimulus that is perceived as painful.
Higher thresholds indicate reduced pain sensitivity.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Central Sensitization Measured by Temporal Summation
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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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.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Change From Baseline in Pain Response Measured by Wind-Up Using Weighted Pinprick Stimuli
大体时间：Baseline, post-intervention (8 weeks), and 3-month follow-up.
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Wind-up ratio assesses pain responses to single versus repeated weighted pinprick stimuli.
A lower wind-up ratio indicates reduced central sensitization.
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Baseline, post-intervention (8 weeks), and 3-month follow-up.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrea D Furlan, MD PhD、University Health Network, Toronto
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月15日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年6月25日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年8月14日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 25-6088
- FURL2025 (其他赠款/资助编号：Workplace Safety and Insurance Board)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
IPD will not be shared as this is a pilot feasibility study with a small sample size of 30 participants.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.