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PNE Effectiveness Cluster Trial (PNE)

28. juli 2020 opdateret af: Elizabeth Lane, University of Utah

The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

This is a cluster randomized trial that involves training regions of physical therapy clinics to use pain neuroscience education or continue with usual care. The investigators will examine outcomes for patients with chronic neck or back pain.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Chronic spinal pain is a very common and costly condition. An estimated 26.4% of Americans have experienced an episode low back pain (LBP) and 13.8% have experienced neck pain in the past 3 months. Lifetime prevalence of spinal pain ranges from 54% to 80% and the estimated healthcare costs for those with spinal pain are 57% higher than those without. While many with acute LBP have a favorable prognosis, those who develop chronic pain continue will experience persistent poor health and place a large burden on the healthcare system.

With growing healthcare costs and mounting disability, there is increased demand for physical therapists to promote more effective self-management strategies for patients with chronic spinal pain. Education is a critical component of self-management. Pain neuroscience education (PNE) is an education method used by physical therapists to help patients understand the biology, physiology and psychological factors influencing their pain experience and to reconcile faulty cognitions and beliefs associated with persistent pain and disability8. PNE has been shown to have positive effects on patient-reported outcomes for a variety of spinal pain conditions. This study will examine the impact of widespread implementation of PNE into routine physical therapy care.

The proposed mechanism of PNE is proposed to relate changes in patients' conceptualization of the pain experience, specifically concepts associated with fear, knowledge, and beliefs of pain. Additional research has identified autonomous motivation and self-efficacy as relevant to patients' behavioral responses to pain. Autonomous motivation is proposed to be an essential factor for behavior change, adhering to a treatment program and persistent positive health behavior changes. Autonomous motivation has not been examined as an influencing factor in the PNE model. Self-efficacy relates to the degree an individual feels they have control over their situation; and high self-efficacy has been associated with more active coping efforts. This study will examine self-efficacy and autonomous motivation as potential mediators of the ability of a PNE intervention improve functional outcomes in a pragmatic clinical environment.

This project's overall goal is to determine the effectiveness of providing physical therapists with PNE training on patient-centered outcomes (physical function and pain interference) for patients with chronic neck or back pain receiving physical therapy. Secondarily, the investigators will explore mechanisms of effects of PNE by examining the role of autonomous motivation and self-efficacy. To accomplish these goals, the investigators will conduct a cluster-randomized clinical trial, randomly assigning groups of clinics to receive PNE training or usual care with no additional training for physical therapists working in the clinic. This design allows for maximum external validity and generalizability across outpatient physical therapy clinics.

Primary Aims I. Compare effectiveness of PNE training vs. no additional training for physical therapists on patient-centered outcomes (physical function and pain interference) for patients with chronic spinal pain. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater improvement in patient-centered outcomes.

Secondary Aims I. Compare the effects of PNE training vs. no additional training for physical therapists on the patient-physical therapist alliance. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater alliance with their physical therapist.

II. Explore the mediating effects of autonomous motivation and self-efficacy on patient-centered outcomes. The investigators hypothesize autonomous motivation and/or self-efficacy will mediate the effects of education on patient-centered outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

316

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35242-8601
        • BenchMark
      • Birmingham, Alabama, Forenede Stater, 35243-2366
        • BenchMark
      • Helena, Alabama, Forenede Stater, 35080-3773
        • BenchMark
      • Hoover, Alabama, Forenede Stater, 35244-1254
        • BenchMark
      • Moody, Alabama, Forenede Stater, 35004-3101
        • BenchMark
      • Phenix City, Alabama, Forenede Stater, 36867-7484
        • BenchMark
    • Georgia
      • Acworth, Georgia, Forenede Stater, 30101-8352
        • Benchmark Physical Therapy
      • Alpharetta, Georgia, Forenede Stater, 30005-4202
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30306-4530
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30308-1245
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30316-6833
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30318-3117
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30319
        • BenchMark
      • Atlanta, Georgia, Forenede Stater, 30342-1461
        • BenchMark
      • Austell, Georgia, Forenede Stater, 30106-8531
        • BenchMark
      • Canton, Georgia, Forenede Stater, 30114-5603
        • BenchMark
      • Canton, Georgia, Forenede Stater, 30115-9376
        • BenchMark
      • Carrollton, Georgia, Forenede Stater, 30117-4456
        • BenchMark
      • Cartersville, Georgia, Forenede Stater, 30121-3305
        • BenchMark
      • Columbus, Georgia, Forenede Stater, 31909-5649
        • BenchMark
      • Dallas, Georgia, Forenede Stater, 30157-4702
        • BenchMark
      • Decatur, Georgia, Forenede Stater, 30033-5305
        • BenchMark
      • Dunwoody, Georgia, Forenede Stater, 30338-4163
        • BenchMark
      • Hiram, Georgia, Forenede Stater, 30141-2692
        • BenchMark
      • Jasper, Georgia, Forenede Stater, 30143-8704
        • BenchMark
      • Kennesaw, Georgia, Forenede Stater, 30144-3210
        • BenchMark
      • Lawrenceville, Georgia, Forenede Stater, 30046-8767
        • Rehab South
      • Marietta, Georgia, Forenede Stater, 30060-9412
        • BenchMark
      • Marietta, Georgia, Forenede Stater, 30062-4197
        • BenchMark
      • Marietta, Georgia, Forenede Stater, 30064-5037
        • BenchMark
      • Marietta, Georgia, Forenede Stater, 30067-8642
        • BenchMark
      • Marietta, Georgia, Forenede Stater, 30068-5418
        • BenchMark
      • Newnan, Georgia, Forenede Stater, 30265-6506
        • Rehab South
      • Peachtree City, Georgia, Forenede Stater, 30269-1571
        • Rehab South
      • Peachtree City, Georgia, Forenede Stater, 30269
        • BenchMark
      • Roswell, Georgia, Forenede Stater, 30075-7524
        • BenchMark
      • Roswell, Georgia, Forenede Stater, 30076-0929
        • BenchMark
      • Roswell, Georgia, Forenede Stater, 30076-3866
        • BenchMark
      • Smyrna, Georgia, Forenede Stater, 30080-9213
        • BenchMark
      • Suwanee, Georgia, Forenede Stater, 30024-9104
        • BenchMark
      • Tucker, Georgia, Forenede Stater, 30084-4916
        • BenchMark

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18-75 at time of first physical therapy session
  • Primary reason for physical therapy is low back and/or neck pain
  • Meets the NIH definition of chronic pain (i.e., neck or back pain on at least half the days in the past 6 months.)

Exclusion Criteria:

  • No spinal surgery within the previous 12 months
  • No evidence of "red flag" conditions (e.g., cauda equine syndrome, cancer, fracture, infection or systemic disease) that requires immediate referral from physical therapy to medical care
  • Not currently known to be pregnant

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual Care
Usual care, no intervention
Eksperimentel: Pain Neuroscience Education Training
The region of clinics randomized to this arm will receive PNE education, which consists of 6 weeks online training followed by an on-site training day.
PNE training will consist of 6 weeks online training followed by one day training session.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Tidsramme: 2 week and 12 week
Change score of Physical Function scores from baseline
2 week and 12 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Tidsramme: 2 week and 12 week
Change score of Pain Interference scores from baseline
2 week and 12 week
pain self-efficacy
Tidsramme: 2 week and 12 week
Measured by Pain Self-Efficacy Questionnaire
2 week and 12 week
Autonomous motivation
Tidsramme: 2 week and 12 week
Measured by Treatment Self-regulation Questionnaire
2 week and 12 week
Therapeutic Alliance
Tidsramme: 2 week and 12 week
As measured by Working Alliance Theory of Change Inventory
2 week and 12 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. maj 2017

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først indsendt

23. maj 2017

Først indsendt, der opfyldte QC-kriterier

24. maj 2017

Først opslået (Faktiske)

30. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 00097154

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lændesmerter

Kliniske forsøg med Pain neuroscience education training

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