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PRT for Chronic Low Back Pain

2026년 7월 9일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2A2
        • Toronto Rehabilitation Institute - University Centre
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Andrea Furlan, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: 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 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.
실험적: 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.
행동: 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 assessments and wear an activity monitor to measure physical activity and sleep patterns.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment Rate
기간: 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.
Through study completion, an average of 1 year
Participant Retention Rate
기간: 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).
Baseline to 3-month follow-up
Intervention Adherence
기간: 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.
During the 8-week intervention period
Participant Satisfaction with the Intervention
기간: 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.
Immediately after the final intervention session, up to 8-week
Participant Acceptability of the Intervention
기간: 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.
Immediately after the final intervention session, up to 8-week

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS)
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Pain Interference Measured by the Brief Pain Inventory (BPI)
기간: 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.
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
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Physical Disability Measured by the Roland-Morris Disability Questionnaire (RMDQ)
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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
기간: Baseline, post-intervention (8 weeks), and 3-month follow-up.
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
기간: 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.
Baseline and throughout the 8-week intervention period.
Change From Baseline in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)
기간: 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.
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
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Pain Processing Measured by Pressure Pain Threshold
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Central Sensitization Measured by Temporal Summation
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.
Change From Baseline in Pain Response Measured by Wind-Up Using Weighted Pinprick Stimuli
기간: 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.
Baseline, post-intervention (8 weeks), and 3-month follow-up.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Health Network, Toronto

협력자

Workplace Safety and Insurance Board

수사관

  • 수석 연구원: Andrea D Furlan, MD PhD, University Health Network, Toronto

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 6월 25일

QC 기준을 충족하는 최초 제출

2026년 7월 9일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PRTforCLBP
  • FURL2025 (기타 보조금/기금 번호: Workplace Safety and Insurance Board)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

IPD will not be shared as this is a pilot feasibility study with a small sample size of 30 participants.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Monitoring and Education에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Chile

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다