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PRT for Chronic Low Back Pain

10. července 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2A2
        • Toronto Rehabilitation Institute - University Centre
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Andrea Furlan, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Jiný: 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.
Experimentální: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Pain Intensity Measured by the Visual Analog Scale (VAS)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Health Network, Toronto

Spolupracovníci

Workplace Safety and Insurance Board

Vyšetřovatelé

  • Vrchní vyšetřovatel: Andrea D Furlan, MD PhD, University Health Network, Toronto

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

25. června 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

10. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PRTforCLBP
  • FURL2025 (Jiné číslo grantu/financování: Workplace Safety and Insurance Board)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Chronická bolest dolní části zad (CLBP)

Klinické studie na Monitoring and Education

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