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Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

10. Oktober 2022 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

280

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Tacoma, Washington, Vereinigte Staaten, 98431
        • Madigan Army Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Verhalten: Complementary and Integrative Therapies
Intervention time period is 3 - 6 weeks.
Aktiver Komparator: Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Verhalten: Standard Rehabilitative Care
Intervention time period is 3 - 6 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline Pain Intensity
Zeitfenster: 3 months
Pain Intensity 10-pt Numeric Rating Scale
3 months
Change from Baseline Pain Impact
Zeitfenster: 3 months
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline, 6 weeks
Salivary Cortisol
baseline, 6 weeks
Oxidative Stress
Zeitfenster: baseline, 6 weeks
Urine Sample
baseline, 6 weeks
Genomic DNA
Zeitfenster: baseline
Buccal Sample
baseline
Army Physical Fitness Test (APFT)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Washington

Mitarbeiter

Madigan Army Medical Center

Ermittler

  • Hauptermittler: Ardith Z Doorenbos, RN, PhD, University of Washington

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juni 2018

Primärer Abschluss (Voraussichtlich)

30. Juni 2023

Studienabschluss (Voraussichtlich)

31. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

8. August 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. September 2017

Zuerst gepostet (Tatsächlich)

29. September 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Oktober 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Oktober 2022

Zuletzt verifiziert

1. Oktober 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00004220

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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