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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).
Full description
All of the below items are research-related unless marked as 'standard of care'. Visits will vary depending on provider-decided treatments and will generally range from 30 minutes to 2 hours in length.
Self-reported pain intensity assessment.
Screening visit (1 hour):
Obtain and document signed Informed Consent document and HIPAA Authorization
Verify subject eligibility based on inclusion/exclusion criteria. Medical record will verify inclusion.
-Record all medications including over the counter the subject is taking. Record morphine milligram equivalents (MME) for patients taking opioid medications. Collect basic demographic information to include phone number, email address, DoD ID, age, race, ethnicity, assigned sex at birth, weight (pounds), height (inches), and BMI, estimated annual income.
Collect additional information to include:
Patient History, was there a precipitating injury, location of pain (neck, thoracic, or lumbar), history of surgery and type of surgery, any history of pain management interventions (injections, ablations, etc) especially related to the subject's chronic axial spine pain
Other therapies for their condition currently receiving or in the last 3 months (ie chiropractic, physical therapy, pain management etc) Randomization: Subjects will not be randomized as this is a single armed cohort study. Subjects will be assigned a unique study code in sequential order beginning with 001.
SURVEY RELATED VISITS
Visit 1 (week 0 can be the same day as screening visit) (30 minutes) (In-person or Virtual):
BASELINE
Visit 2 (Week 4) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 3 (Week 8) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 4 (Week 12) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 5 (Week 16) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 6 (Week 20) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 7 (Week 24) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
Visit 8 (Week 28) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
TREATMENT VISITS Treatments given in Integrative Medicine Clinic will be at provider discretion. Subjects will attend a minimum of 3 visits then additional treatment sessions will be at provider discretion as well.
The following semi structured clinical algorithm will be used by providers in the clinic.
Visit 1:
Initial interview with focus on whole person
Microcurrent standard protocols (Standard concussion protocol, Spinal Cord long)
Myofascial work to include transverse abdominus teaching, rectus abdominus release, other myofascial, time permitting or as needed
Optional Loan of microcurrent box with protocols at physician discretion
Optional loan of avazzia or alpha stim at physician discretion
Home Exercise Program handout (HEP2go)
Visit 2:
Assess effect of prior myofascial work
Re-education of TA activation, additional myofascial work as needed (including lower trap and
/or glut med activation)
Assess effect of Microcurrent
Optional Loan of microcurrent box with protocols at physician discretion
Optional loan of avazzia or alpha stim at physician discretion
create plan for visit 3 (this could include additional myofascial work, shock wave therapy, acupuncture/dry needling, avazzia or alpha stim)
Visits 3 through final:
Continue treatment with any or all of the following modalities
a. Myofascial treatments (functional neuromyofascial techniques [FNT], cupping, gua sha, active needling) b. Frequency Specific Microcurrent (FSM) c. Avazzia d. Extracorporeal shock wave therapy (ESWT) e. Acupuncture/dry needling f. Alpha stim (cranio-electric stimulation) Coordinators will monitor subject visits either in-person post each visit or by accessing the EMR post each visit to record visit details. Visit Details to Record
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
Enrolled in other pain management program (e.g. pain management, PT
/OT)
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
<3 months post-partum
Hypermobility disorders such as Ehlers Danlos
Active cancer (cancer in remission is not an exclusion)
Implanted electrical devices that cannot be turned off (ie pacemaker); implanted stimulators or pumps that can be turned off are not exclusionary
Injury or surgery within the last 6 weeks
Dementia
Delirium
Inability to make medical decisions or understand treatment plan as decided upon by principle or associate investigators
Undergoing medical evaluation board
Currently in the process of establishing or appealing VA disability rating, or planning to do so within the study period
Primary purpose
Allocation
Interventional model
Masking
125 participants in 1 patient group
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Central trial contact
Daniel Shaffer, BSBA
Data sourced from clinicaltrials.gov
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