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PNE Effectiveness Cluster Trial (PNE)

28. juli 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

316

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Usual Care
Usual care, no intervention
Eksperimentell: 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.
Annen: Pain neuroscience education training
PNE training will consist of 6 weeks online training followed by one day training session.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Utah

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. mai 2017

Primær fullføring (Faktiske)

1. juni 2019

Studiet fullført (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først innsendt

23. mai 2017

Først innsendt som oppfylte QC-kriteriene

24. mai 2017

Først lagt ut (Faktiske)

30. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 00097154

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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