Brief Summary

With vast numbers of active-duty members restricted from their specific duties or deemed unfit for deployment because of low back pain, both the mission of the Department of Defense and overall military workflow can be significantly impacted. More than restriction from duty or being barred from deployment, studies have shown musculoskeletal conditions were among the top reasons for medical disability retirement in the Army and Marine Corps (Niebuhr; Sikorski). Given the significant time, money, and resources invested in training these members, each day of inactivity or disability detrimentally affects the execution of the military's mission. Therefore, precise diagnosis and effective treatment modalities are paramount to foster healing and reduce recovery time. From an operational standpoint, the United States Department of Defense (DoD) is specifically interested in using tailored integrative medicine modalities to manage chronic conditions encountered in the military health system. Not just chronic pain, but polytrauma and the triad of conditions it encompasses; traumatic brain injury and post-traumatic stress disorder combined with chronic pain (Madsen, Kim, Bedard). The DoD's goal is also to decrease opioid prescribing and the addiction and altered state associated with opioids. AT the Nellis Integrative Medicine Clinic, physicians, a chiropractor, and nurses are engaged in the treatment of patients. All personnel are trained in the various modalities available in the clinics. A variety of modalities are utilized in the clinic. This prospective study will evaluate the effectiveness of the many modalities used in the Integrative Medicine Clinic (such as acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies). Most patients receive treatments using multiple modalities. DoD goals align with our experiences in the Integrative Medicine Clinic at Mike O'Callaghan Military Medical Center. Many servicemembers and dependents in our clinic are trying to avoid surgery, or their pain medications - opioid or not - are no longer working. Additionally, many patients are trying to avoid Do Not Fly status caused by pharmacologic approaches. Patient experiences at our IMC also correlate with a study where 80% of people surveyed felt integrative medicine should be routinely offered at all MTFs (Ross). While our patients generally are not on opioids, we have anecdotally noted a reduction or cessation of opioids in several patients. The impacts of such a reduction in opioid usage for military readiness is clear (Madsen).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

125

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline

26mo left

Started Aug 2025

Typical duration for not_applicable chronic-pain

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress26%

Aug 2025Jul 2028

First Submitted

Initial submission to the registry

July 23, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed

5 days until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

July 23, 2025

Last Update Submit

October 16, 2025

Conditions

Chronic Pain

Keywords

integrative medicine

Outcome Measures

Primary Outcomes (10)

Dallas Pain Questionnaire
16 item quality of life questionnaire assessing multiple domains
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
PROMIS physical function form 6b
6 questions evaluating physical function
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Defense and Veterans Pain Rating Scale
pain assessment tool using numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
PEG (pain average, enjoyment of life, and general activity)
assesses pain intensity and interference
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Patient Health Questionnaire 2-item (PHQ-2)
measures depressed mood and anhedonia over past 2 weeks
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Patient health questionnaire 9-item
measures more detailed depressed mood and anhedonia if patient scores 3 or higher on phq-2
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Generalized Anxiety Disorder 2-item
screening tool for generalized anxiety disorder
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Generalized Anxiety Disorder 7-item
extended screening tool for generalized anxiety disorder to use if subjects score 3 or higher on GAD-2
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Pain Catastrophizing Scale
quantifies pain experience (rumination, magnification, and helplessness)
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Pittsburgh Sleep Quality Index
Self-report questionnaire that assesses sleep quality over a one-month time interval. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality.
baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)

Study Arms (1)

Integrative Medicine (pre to post treatment)

EXPERIMENTAL

Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.

Other: AcupunctureOther: myofascial therapyOther: microcurrent therapyOther: LASEROther: extracorporeal shockwave therapyOther: Pulsed electromagnetic therapiesOther: Miscellaneous integrative medicine