Chronic PainPAINNCT07094282
Prospective Assessment of Integrative Therapies for Neuromusculoskeletal Pain (PAIN)
A study testing Acupuncture, myofascial therapy and microcurrent therapy in people with Chronic Pain, run by David Moss at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Acupuncture, myofascial therapy and microcurrent therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
Daniel Shaffer, Daniel.W.Shaffer.CIV@health.mil
About this study
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.
Read more
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).
Read the detailed 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:
- Beneficiary Status (Active-Duty, Retired Active-Duty, dependent, Reservist)
- rank (if applicable),
- employment status and description (full time, part time, unemployed, retired, homemaker) number of deployments (if applicable), Marital status (Married, Domestic Partners, Divorced, Widow/er, separated, single/never married)
- education (military training; high school/GED; some college; 2 year college; 4 year college; some graduate work; completed master's or professional degree; completed Ph.D., law degree, MD, similar advanced professional degree)
- 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
- Subject will fill out the following Standard of Care Patient Questionnaires:
- PROMIS Physical Function Form 6b
- 6 questions evaluating physical function
- DVPRS 0-10 Scale
- pain assessment tool using numerical rating scale enhances by functional word descriptors, color coding, and pictorial facial expressions
- PEG
- Assesses pain intensity and interference
- Patient Health Questionnaire 2-item (PHQ-2)
- Measures depressed mood and anhedonia over past 2 weeks
- Survey is extended to a 9-item PHQ-9 only for subjects scoring 3 or higher on the PHQ-2
- Generalized Anxiety Disorder 2-item (GAD-2)
- Screening tool for generalized anxiety disorder
- Survey is extended to a 7-item GAD-7 only for subjects scoring 3 or higher on the GAD-2
- Pain Catastrophizing Scale
- Quantifies pain experience (rumination, magnification, and helplessness)
- Pittsburgh Sleep Quality Index
- Dallas Pain Questionnaire
- 16 item quality of life questionnaire assessing multiple domains
- Patient receives treatment preferably same day, but within 72 hours
- Scores may be pulled from patient Electronic Medical Record
Visit 2 (Week 4) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 3 (Week 8) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 4 (Week 12) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Patient receives treatment at provider discretion
- Scores may be pulled from patient Electronic Medical Record
Visit 5 (Week 16) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 6 (Week 20) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 7 (Week 24) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 8 (Week 28) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
- Treatment Helpfulness Questionnaire
- Active duty members will be asked if duty, fitness or mobility restrictions were lifted during the study period
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 (Rx3) 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
- 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
- Visit Number (1-10, >10)
- ICD-10 codes
- Examples
- M54.2 Cervicalgia
- M54.5 Low Back Pain
- M79.7 Fibromyalgia
- Z73.3 PTSD*
- M54.9 Dorsalgia, unspecified
- F41.9 Anxiety
- M25.51 Shoulder Pain
- M54.6 Thoracic Spinal Pain
- M72.2 Plantar Fasciitis
- L90.5 Scar Conditions and Fibrosis of Skin
- Modalities Used
- Examples
- Myofascial modalities (FNT, cupping, scraping/gua sha, active needling)
- FSM
- Avazzia
- Acupuncture
- Dry needling
- Alpha Stim
- ESWT
- Conditions
- Chronic Pain
- Being tested
- Acupuncture, myofascial therapy, microcurrent therapy, LASER, extracorporeal shockwave therapy
- Keywords
- integrative medicine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Integrative Medicine: Acupuncture treatment
myofascial therapyOther
Integrative Medicine: myofascial therapy to include transverse abdominus teaching, rectus abdominus release, functional neuromyofascial techniques, cupping, gua sha, active needling.
microcurrent therapyOther
Integrative Medicine: Microcurrent
LASEROther
Integrative Medicine: LASER
extracorporeal shockwave therapyOther
Integrative Medicine: Extracorporeal shockwave therapy
Pulsed electromagnetic therapiesOther
Integrative Medicine: Pulsed electromagnetic therapies
Miscellaneous integrative medicineOther
other integrative medicine modalities
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acupuncture; Other: myofascial therapy; Other: microcurrent therapy; Other: LASER; Other: extracorporeal shockwave therapy; Other: Pulsed electromagnetic therapies; Other: Miscellaneous integrative medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dallas Pain Questionnaire
16 item quality of life questionnaire assessing multiple domains
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start4 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group single site prospective cohort. Patients will act as their own control with pre-intervention scores.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Moss
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, David Moss, Mike O'Callaghan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094282
- Sponsor's protocol ID
- MOMMC.2025.0019
- Acronym
- PAIN
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic and clinical data will be acquired from 125 participants. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NLM Data Archive (NDA) (clinicaltrials.gov) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NLM requires data measured from human subjects to be shared using the NDA. Demographic data, clinical data, data collection tools and study protocols will be made available in the NDA.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Integrative Therapies for Neuromusculoskeletal Pain (PAIN)
- ClinicalTrials.gov ID
- NCT07094282
- Acronym / sponsor ID
- PAIN / MOMMC.2025.0019
- Conditions
- Chronic Pain
- Keywords
- integrative medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- David MossUS federal agency
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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:
- Beneficiary Status (Active-Duty, Retired Active-Duty, dependent, Reservist)
- rank (if applicable),
- employment status and description (full time, part time, unemployed, retired, homemaker) number of deployments (if applicable), Marital status (Married, Domestic Partners, Divorced, Widow/er, separated, single/never married)
- education (military training; high school/GED; some college; 2 year college; 4 year college; some graduate work; completed master's or professional degree; completed Ph.D., law degree, MD, similar advanced professional degree)
- 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
- Subject will fill out the following Standard of Care Patient Questionnaires:
- PROMIS Physical Function Form 6b
- 6 questions evaluating physical function
- DVPRS 0-10 Scale
- pain assessment tool using numerical rating scale enhances by functional word descriptors, color coding, and pictorial facial expressions
- PEG
- Assesses pain intensity and interference
- Patient Health Questionnaire 2-item (PHQ-2)
- Measures depressed mood and anhedonia over past 2 weeks
- Survey is extended to a 9-item PHQ-9 only for subjects scoring 3 or higher on the PHQ-2
- Generalized Anxiety Disorder 2-item (GAD-2)
- Screening tool for generalized anxiety disorder
- Survey is extended to a 7-item GAD-7 only for subjects scoring 3 or higher on the GAD-2
- Pain Catastrophizing Scale
- Quantifies pain experience (rumination, magnification, and helplessness)
- Pittsburgh Sleep Quality Index
- Dallas Pain Questionnaire
- 16 item quality of life questionnaire assessing multiple domains
- Patient receives treatment preferably same day, but within 72 hours
- Scores may be pulled from patient Electronic Medical Record
Visit 2 (Week 4) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 3 (Week 8) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 4 (Week 12) (60 Minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Patient receives treatment at provider discretion
- Scores may be pulled from patient Electronic Medical Record
Visit 5 (Week 16) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 6 (Week 20) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 7 (Week 24) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
Visit 8 (Week 28) (60 minutes) (In-person or Virtual) Research coordinator with record morphine milligram equivalents (MME) for patients taking opioid medications.
- Subject will complete the following Standard of Care Patient Questionnaires:
- PEG
- PHQ-2 or PHQ-9 (PHQ-2 score > 2)
- GAD-2 or GAD-7 (GAD-2 score > 2)
- Pain Catastrophizing Scale
- Pittsburgh Sleep Quality Index
- DVPRS 0-10 Scale
- PROMIS Physical Function Form 6b
- Dallas Pain Questionnaire
- Scores may be pulled from patient Electronic Medical Record
- Treatment Helpfulness Questionnaire
- Active duty members will be asked if duty, fitness or mobility restrictions were lifted during the study period
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 (Rx3) 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
- 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
- Visit Number (1-10, >10)
- ICD-10 codes
- Examples
- M54.2 Cervicalgia
- M54.5 Low Back Pain
- M79.7 Fibromyalgia
- Z73.3 PTSD*
- M54.9 Dorsalgia, unspecified
- F41.9 Anxiety
- M25.51 Shoulder Pain
- M54.6 Thoracic Spinal Pain
- M72.2 Plantar Fasciitis
- L90.5 Scar Conditions and Fibrosis of Skin
- Modalities Used
- Examples
- Myofascial modalities (FNT, cupping, scraping/gua sha, active needling)
- FSM
- Avazzia
- Acupuncture
- Dry needling
- Alpha Stim
- ESWT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group single site prospective cohort. Patients will act as their own control with pre-intervention scores.
| Arm | Type | Receives |
|---|---|---|
| Integrative Medicine (pre to post treatment) | Experimental | Other: Acupuncture, Other: myofascial therapy, Other: microcurrent therapy, Other: LASER, Other: extracorporeal shockwave therapy, Other: Pulsed electromagnetic therapies, Other: Miscellaneous integrative medicinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureIntegrative Medicine: Acupuncture treatment | Other | Integrative Medicine (pre to post treatment) |
| myofascial therapyIntegrative Medicine: myofascial therapy to include transverse abdominus teaching, rectus abdominus release, functional neuromyofascial techniques, cupping, gua sha, active needling. | Other | Integrative Medicine (pre to post treatment) |
| microcurrent therapyIntegrative Medicine: Microcurrent | Other | Integrative Medicine (pre to post treatment) |
| LASERIntegrative Medicine: LASER | Other | Integrative Medicine (pre to post treatment) |
| extracorporeal shockwave therapyIntegrative Medicine: Extracorporeal shockwave therapy | Other | Integrative Medicine (pre to post treatment) |
| Pulsed electromagnetic therapiesIntegrative Medicine: Pulsed electromagnetic therapies | Other | Integrative Medicine (pre to post treatment) |
| Miscellaneous integrative medicineother integrative medicine modalities | Other | Integrative Medicine (pre to post treatment) |
Primary outcome
Dallas Pain Questionnaire
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)
16 item quality of life questionnaire assessing multiple domains
PROMIS physical function form 6b
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)
6 questions evaluating physical function
Defense and Veterans Pain Rating Scale
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)
pain assessment tool using numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions
PEG (pain average, enjoyment of life, and general activity)
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)
assesses pain intensity and interference
Patient Health Questionnaire 2-item (PHQ-2)
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)
measures depressed mood and anhedonia over past 2 weeks
Patient health questionnaire 9-item
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)
measures more detailed depressed mood and anhedonia if patient scores 3 or higher on phq-2
Generalized Anxiety Disorder 2-item
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)
screening tool for generalized anxiety disorder
Generalized Anxiety Disorder 7-item
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)
extended screening tool for generalized anxiety disorder to use if subjects score 3 or higher on GAD-2
Pain Catastrophizing Scale
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)
quantifies pain experience (rumination, magnification, and helplessness)
Pittsburgh Sleep Quality Index
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. Demographic and clinical data will be acquired from 125 participants. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NLM Data Archive (NDA) (clinicaltrials.gov) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NLM requires data measured from human subjects to be shared using the NDA. Demographic data, clinical data, data collection tools and study protocols will be made available in the NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, myofascial therapy and microcurrent therapy in people with Chronic Pain, run by David Moss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Shaffer, BSBA (702-653-2067, daniel.w.shaffer.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dallas Pain Questionnaire (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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.