Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Complementary and Integrative Therapies; Behavioral: Standard Rehabilitative Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Pain Intensity	Pain Intensity 10-pt Numeric Rating Scale	3 months
Change from Baseline Pain Impact	Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Reported Outcome Measurement Information System	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Anxiety	Patient Reported Outcome Measurement Information System	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Emotional Distress - Anger	Patient Reported Outcome Measurement Information System	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Sleep Disturbance	Patient Reported Outcome Measurement Information System	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Fatigue	Patient Reported Outcome Measurement Information System	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
PTSD	Primary Care PTSD Screen	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Activation Measure	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	Drug Use Questionnaire	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing	Pain Catastrophizing Scale	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Kinesiophobia	Tampa Scale for Kinesiophobia	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self-Efficacy	Pain Self Efficacy Questionnaire	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance	Chronic Pain Acceptance Questionnaire	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Functional Capacity	Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization	Opioid Utilization Screener	baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Cortisol	Salivary Cortisol	baseline, 6 weeks
Oxidative Stress	Urine Sample	baseline, 6 weeks
Genomic DNA	Buccal Sample	baseline
Army Physical Fitness Test (APFT)	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Madigan Army Medical Center
• Investigators: Principal Investigator: Ardith Z Doorenbos, RN, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Pain; Military
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: STUDY00004220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No