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| Name | Class |
|---|---|
| Scripps Center for Integrative Medicine | OTHER |
| United States Naval Medical Center, San Diego | FED |
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Musculoskeletal injuries resulting in pain are one of the most common reasons for disability and missed duty among military personnel. Additionally, these injuries may create impairment in the area of optimal function, sleep and mood that may not be completely resolved with currently available therapies. This scenario creates the setting for testing and incorporation of additional treatment options to potentially improve care outcomes. Recent investigations have examined the adjunctive use of auricular therapy, which utilizes various interventions, typically needle-based, to stimulate the ear. This intervention appears to modulate the autonomic nervous system to produce more rapid onset of pain relief and reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy, active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged to outpatient care for treatment will be studied. Subjects randomized to auricular treatment will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months from a clinician trained in auricular therapy. This trial will specifically examine whether the addition of a specific auricular therapy protocol to standard care will have a beneficial impact on the pain and functionality of military personnel who sustain an acute or sub-acute musculoskeletal injury.
Musculoskeletal injuries resulting in pain are one of the most common reasons for disability and missed duty among military personnel. Additionally, these injuries may create impairment in the area of optimal function, sleep and mood that may not be completely resolved with currently available therapies. This scenario creates the setting for testing and incorporation of additional treatment options to potentially improve care outcomes. Recent investigations have examined the adjunctive use of auricular therapy, which utilizes various interventions, typically needle-based, to stimulate the ear. This intervention appears to modulate the autonomic nervous system to produce more rapid onset of pain relief and reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy, 150 subjects will be enrolled at the Naval Medical Center San Diego. Subjects will be active duty personnel aged 18-60 years old presenting with an acute or sub-acute musculoskeletal injury triaged to outpatient care for treatment. Subjects randomized to auricular treatment will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months from a clinician trained in auricular therapy. This trial will specifically examine whether the addition of a specific auricular therapy protocol to standard care will have a beneficial impact on the pain and functionality of military personnel who sustain an acute or sub-acute musculoskeletal injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Acupuncture Plus Usual Care | Experimental | Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy. |
|
| Usual Care Only | Active Comparator | Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupuncture | Other | Auricular therapy for treatment of musculoskeletal pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary musculoskeletal pain | Standardized scales and clinical assessments to determine if the addition of AT will significantly decrease pain at noted time endpoints after initiation of treatment compared to UC. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Musculoskeletal pain related to co-morbities | Standardized scales and clinical assessments to determine if the addition of AT will significantly improve pain related co-morbidities (based on the 0-10 BPI Pain interference scale and SF-8) at noted endpoints after initiation of treatment than UC. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bonakdar, MD | Scripps Integrative Medical Center, La Jolla, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San DIego | San Diego | California | 92134 | United States |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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| Usual Care | Other | Usual care therapy consists of over-the-counter and prescribed pharmacotherapy |
|
| Return of functional ability |
Standardized scales and clinical assessments to determine if the addition of AT will significantly improve functionality at noted endpoints after initiation of treatment vs. UC. |
| 12 weeks |
| Reduction of pain medication use | Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC. | 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |