Prospective Assessment of Integrative Therapies for Neuromusculoskeletal Pain (PAIN)

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Moss

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 or older referred to the Nellis Integrative Medicine Clinic chronic back or neck pain

Pain Chronicity Threshold (pain score ≥4/10 documented in EMR or reported by patient at least 2 times in one year and at least 30 days apart).

Disqualifiers

Enrolled in other pain management program (e.g. pain management, PT

Anticipated Change of station, deployment, retirement from military service, separation from active or reserve military service (includes national guard) or plan to discontinue enrollment at MOMMC in <6 months

Planned surgery during the study period

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Acupuncture

    Other intervention

    Integrative Medicine: Acupuncture treatment

  • myofascial therapy

    Other intervention

    Integrative Medicine: myofascial therapy to include transverse abdominus teaching, rectus abdominus release, functional neuromyofascial techniques, cupping, gua sha, active needling.

  • microcurrent therapy

    Other intervention

    Integrative Medicine: Microcurrent

  • LASER

    Other intervention

    Integrative Medicine: LASER

  • extracorporeal shockwave therapy

    Other intervention

    Integrative Medicine: Extracorporeal shockwave therapy

  • Pulsed electromagnetic therapies

    Other intervention

    Integrative Medicine: Pulsed electromagnetic therapies

  • Miscellaneous integrative medicine

    Other intervention

    other integrative medicine modalities

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: Integrative Medicine (pre to post treatment)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Dallas Pain Questionnaire

16 item quality of life questionnaire assessing multiple domains

Time frame
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)
2

PROMIS physical function form 6b

6 questions evaluating physical function

Time frame
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)
3

Defense and Veterans Pain Rating Scale

pain assessment tool using numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions

Time frame
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)
4

PEG (pain average, enjoyment of life, and general activity)

assesses pain intensity and interference

Time frame
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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Moss

Lead sponsor

Mike O'Callaghan Military Hospital

Sponsor institution