Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Functional and Occupational Rehabilitation of Troops

NCT06898866

Chronic Musculoskeletal Pain

NOT_YET_RECRUITING

Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain

NCT02132910

Lower Back Pain

COMPLETED NA

Rehabilitation Following Lumbar Disc Surgery

NCT00894972

Lumbar Disc Herniation Radiculopathy

COMPLETED NA

Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain

NCT01556581

Low Back Pain

COMPLETED NA

Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?

NCT06544525

Low Back Pain

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Multiple Assignment Randomized Trial (SMART)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Complementary and Integrative Therapies

Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction

Group Type EXPERIMENTAL

Complementary and Integrative Therapies

Intervention Type BEHAVIORAL

Intervention time period is 3 - 6 weeks.

Standard Rehabilitative Care

Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy

Group Type ACTIVE_COMPARATOR

Standard Rehabilitative Care

Intervention Type BEHAVIORAL

Intervention time period is 3 - 6 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Complementary and Integrative Therapies

Intervention time period is 3 - 6 weeks.

Intervention Type BEHAVIORAL

Standard Rehabilitative Care

Intervention time period is 3 - 6 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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