Pain Reprocessing Therapy for Chronic Low Back Pain: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Monitoring and Education (Other)
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.
干预措施: Pain Reprocessing Therapy (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS)(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI)(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(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ)(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)(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)(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)(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(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Physical Activity and Sleep Measured by Actigraphy(Baseline and throughout the 8-week intervention period.)
- Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)(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(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Pain Processing Measured by Pressure Pain Threshold(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Central Sensitization Measured by Temporal Summation(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
- Change From Baseline in Pain Response Measured by Wind-Up Using Weighted Pinprick Stimuli(Baseline, post-intervention (8 weeks), and 3-month follow-up.)
研究者
Andrea D. Furlan
Clinical Professor
University Health Network, Toronto