- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03168165
PNE Effectiveness Cluster Trial (PNE)
The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35242-8601
- BenchMark
-
Birmingham, Alabama, Stati Uniti, 35243-2366
- BenchMark
-
Helena, Alabama, Stati Uniti, 35080-3773
- BenchMark
-
Hoover, Alabama, Stati Uniti, 35244-1254
- BenchMark
-
Moody, Alabama, Stati Uniti, 35004-3101
- BenchMark
-
Phenix City, Alabama, Stati Uniti, 36867-7484
- BenchMark
-
-
Georgia
-
Acworth, Georgia, Stati Uniti, 30101-8352
- Benchmark Physical Therapy
-
Alpharetta, Georgia, Stati Uniti, 30005-4202
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30306-4530
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30308-1245
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30316-6833
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30318-3117
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30319
- BenchMark
-
Atlanta, Georgia, Stati Uniti, 30342-1461
- BenchMark
-
Austell, Georgia, Stati Uniti, 30106-8531
- BenchMark
-
Canton, Georgia, Stati Uniti, 30114-5603
- BenchMark
-
Canton, Georgia, Stati Uniti, 30115-9376
- BenchMark
-
Carrollton, Georgia, Stati Uniti, 30117-4456
- BenchMark
-
Cartersville, Georgia, Stati Uniti, 30121-3305
- BenchMark
-
Columbus, Georgia, Stati Uniti, 31909-5649
- BenchMark
-
Dallas, Georgia, Stati Uniti, 30157-4702
- BenchMark
-
Decatur, Georgia, Stati Uniti, 30033-5305
- BenchMark
-
Dunwoody, Georgia, Stati Uniti, 30338-4163
- BenchMark
-
Hiram, Georgia, Stati Uniti, 30141-2692
- BenchMark
-
Jasper, Georgia, Stati Uniti, 30143-8704
- BenchMark
-
Kennesaw, Georgia, Stati Uniti, 30144-3210
- BenchMark
-
Lawrenceville, Georgia, Stati Uniti, 30046-8767
- Rehab South
-
Marietta, Georgia, Stati Uniti, 30060-9412
- BenchMark
-
Marietta, Georgia, Stati Uniti, 30062-4197
- BenchMark
-
Marietta, Georgia, Stati Uniti, 30064-5037
- BenchMark
-
Marietta, Georgia, Stati Uniti, 30067-8642
- BenchMark
-
Marietta, Georgia, Stati Uniti, 30068-5418
- BenchMark
-
Newnan, Georgia, Stati Uniti, 30265-6506
- Rehab South
-
Peachtree City, Georgia, Stati Uniti, 30269-1571
- Rehab South
-
Peachtree City, Georgia, Stati Uniti, 30269
- BenchMark
-
Roswell, Georgia, Stati Uniti, 30075-7524
- BenchMark
-
Roswell, Georgia, Stati Uniti, 30076-0929
- BenchMark
-
Roswell, Georgia, Stati Uniti, 30076-3866
- BenchMark
-
Smyrna, Georgia, Stati Uniti, 30080-9213
- BenchMark
-
Suwanee, Georgia, Stati Uniti, 30024-9104
- BenchMark
-
Tucker, Georgia, Stati Uniti, 30084-4916
- BenchMark
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Usual Care
Usual care, no intervention
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Lasso di tempo: 2 week and 12 week
|
Change score of Physical Function scores from baseline
|
2 week and 12 week
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Lasso di tempo: 2 week and 12 week
|
Change score of Pain Interference scores from baseline
|
2 week and 12 week
|
pain self-efficacy
Lasso di tempo: 2 week and 12 week
|
Measured by Pain Self-Efficacy Questionnaire
|
2 week and 12 week
|
Autonomous motivation
Lasso di tempo: 2 week and 12 week
|
Measured by Treatment Self-regulation Questionnaire
|
2 week and 12 week
|
Therapeutic Alliance
Lasso di tempo: 2 week and 12 week
|
As measured by Working Alliance Theory of Change Inventory
|
2 week and 12 week
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Lane E, Magel JS, Thackeray A, Greene T, Fino NF, Puentedura EJ, Louw A, Maddox D, Fritz JM. Effectiveness of training physical therapists in pain neuroscience education for patients with chronic spine pain: a cluster-randomized trial. Pain. 2022 May 1;163(5):852-860. doi: 10.1097/j.pain.0000000000002436.
- Lane E, Fritz JM, Greene T, Maddox D. The effectiveness of training physical therapists in pain neuroscience education on patient reported outcomes for patients with chronic spinal pain: a study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2018 Oct 25;19(1):386. doi: 10.1186/s12891-018-2269-2.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 00097154
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Lombalgia
-
Bozok UniversityCompletatoAllattamento al seno | Comunicazione Teach BackTacchino
-
Health Services Academy, Islamabad, PakistanSconosciutomHealth | Riammissione | Comunicazione Teach BackPakistan
-
Rush University Medical CenterCompletatoEducazione del paziente | Comunicazione Teach Back | Istruzioni dopo la visita | Comprensione del pazienteStati Uniti
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinAttivo, non reclutanteSimulazione di malattia fisica | Complicazione della tracheotomia | Comunicazione Teach BackStati Uniti
-
Marmara UniversityAttivo, non reclutanteComunicazione Teach BackTacchino
-
FibroGenAstraZeneca; Astellas Pharma IncTerminatoMDS primaria (Very Low, Low o Intermediate IPSS-R WithStati Uniti, Australia, Belgio, Germania, Israele, Italia, Corea, Repubblica di, Federazione Russa, Spagna, Regno Unito, Francia, Tacchino, Canada, Danimarca, India, Polonia
-
University of ValenciaCompletatoMalattie cardiache | Comunicazione Teach BackSpagna
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
Duke UniversityTerminatoArtrite | Artrosi al ginocchio | Artropatia del ginocchio | Comunicazione Teach BackStati Uniti
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)CompletatoEfficacia e Tolleranza di B-Back® sulla Sindrome da BurnoutFrancia
Prove cliniche su Pain neuroscience education training
-
Duke UniversityReclutamentoCancro al senoStati Uniti