Clinical trial NCT03297905: Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Official title: Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Military
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Madigan Army Medical Center
First posted: 2017-09-29
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Pain Intensity
timeFrame: 3 months
measure: Change from Baseline Pain Impact
timeFrame: 3 months
Secondary outcomes:
measure: Depression
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Anxiety
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Emotional Distress - Anger
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Sleep Disturbance
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Fatigue
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: PTSD
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Patient Activation Measure
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Drug Use
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Pain Catastrophizing
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Kinesiophobia
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Pain Self-Efficacy
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Chronic Pain Acceptance
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Functional Capacity
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Opioid Utilization
timeFrame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
measure: Cortisol
timeFrame: baseline, 6 weeks
measure: Oxidative Stress
timeFrame: baseline, 6 weeks
measure: Genomic DNA
timeFrame: baseline
measure: Army Physical Fitness Test (APFT)
timeFrame: baseline, 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Ardith Z Doorenbos, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: