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Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

10 octobre 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

280

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Washington
      • Tacoma, Washington, États-Unis, 98431
        • Madigan Army Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Comportemental: Complementary and Integrative Therapies
Intervention time period is 3 - 6 weeks.
Comparateur actif: Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Comportemental: Standard Rehabilitative Care
Intervention time period is 3 - 6 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline Pain Intensity
Délai: 3 months
Pain Intensity 10-pt Numeric Rating Scale
3 months
Change from Baseline Pain Impact
Délai: 3 months
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Depression
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: baseline, 6 weeks
Salivary Cortisol
baseline, 6 weeks
Oxidative Stress
Délai: baseline, 6 weeks
Urine Sample
baseline, 6 weeks
Genomic DNA
Délai: baseline
Buccal Sample
baseline
Army Physical Fitness Test (APFT)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Washington

Collaborateurs

Madigan Army Medical Center

Les enquêteurs

  • Chercheur principal: Ardith Z Doorenbos, RN, PhD, University of Washington

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juin 2018

Achèvement primaire (Anticipé)

30 juin 2023

Achèvement de l'étude (Anticipé)

31 décembre 2023

Dates d'inscription aux études

Première soumission

8 août 2017

Première soumission répondant aux critères de contrôle qualité

26 septembre 2017

Première publication (Réel)

29 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 octobre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 octobre 2022

Dernière vérification

1 octobre 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY00004220

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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