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Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

10 ottobre 2022 aggiornato da: Ardith Doorenbos, University of Washington

Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.

The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.

Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.

Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.

Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.

Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.

Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

280

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Tacoma, Washington, Stati Uniti, 98431
        • Madigan Army Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Active duty service members
  • Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
  • Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities

Exclusion Criteria:

  • Major surgeries within past 6 months or planned within next 6 months
  • Unstable psychological disorders
  • Active substance use disorder

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Comportamentale: Complementary and Integrative Therapies
Intervention time period is 3 - 6 weeks.
Comparatore attivo: Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Comportamentale: Standard Rehabilitative Care
Intervention time period is 3 - 6 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Pain Intensity
Lasso di tempo: 3 months
Pain Intensity 10-pt Numeric Rating Scale
3 months
Change from Baseline Pain Impact
Lasso di tempo: 3 months
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Reported Outcome Measurement Information System
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Anxiety
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Reported Outcome Measurement Information System
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Emotional Distress - Anger
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Reported Outcome Measurement Information System
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Sleep Disturbance
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Reported Outcome Measurement Information System
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Fatigue
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Reported Outcome Measurement Information System
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
PTSD
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Primary Care PTSD Screen
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Activation Measure
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Drug Use
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Drug Use Questionnaire
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing Scale
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Kinesiophobia
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Tampa Scale for Kinesiophobia
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self-Efficacy
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self Efficacy Questionnaire
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance Questionnaire
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Functional Capacity
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization
Lasso di tempo: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization Screener
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Cortisol
Lasso di tempo: baseline, 6 weeks
Salivary Cortisol
baseline, 6 weeks
Oxidative Stress
Lasso di tempo: baseline, 6 weeks
Urine Sample
baseline, 6 weeks
Genomic DNA
Lasso di tempo: baseline
Buccal Sample
baseline
Army Physical Fitness Test (APFT)
Lasso di tempo: baseline, 6 weeks, 3 months, 6 months
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
baseline, 6 weeks, 3 months, 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

Madigan Army Medical Center

Investigatori

  • Investigatore principale: Ardith Z Doorenbos, RN, PhD, University of Washington

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 giugno 2018

Completamento primario (Anticipato)

30 giugno 2023

Completamento dello studio (Anticipato)

31 dicembre 2023

Date di iscrizione allo studio

Primo inviato

8 agosto 2017

Primo inviato che soddisfa i criteri di controllo qualità

26 settembre 2017

Primo Inserito (Effettivo)

29 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00004220

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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