Clinical trial NCT02263001: Acupuncture Therapy for Treatment of Musculoskeletal Pain
Official title: Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Auricular therapy
Acupuncture
Acute, sub-acute pain
Auricular Acupuncture Needles
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Scripps Center for Integrative Medicine
name: United States Naval Medical Center, San Diego
First posted: 2014-10-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Active duty personnel with a musculoskeletal injury
* Injuries eligible for inclusion include all acute or subacute (\<3 months in duration) non-fracture related musculoskeletal injuries of the axial or peripheral skeleton
* Examples of injuries meeting inclusion include acute or sub-acute injuries of the neck, low back as well as the upper and lower extremities
* Individuals with the pre-existing chronic pain pain greater than 3 months in duration will be eligible if they have a presenting acute or sub-acute pain condition as described above

Exclusion Criteria:

* Injuries involving hospitalization or surgery for treatment in the presenting area of pain
* Rheumatologic and autoimmune conditions which may be creating pain, such as rheumatoid arthritis, advanced osteoarthritis, or spinal stenosis
* Contra-indication to needle use including known bleeding disorder and psychogenic issues related to needle use (needle-phobia)"
* Evidence or history of clinically significant immune deficiency, hematological, oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or severe allergic disease (including to metals and adhesive tapes) which could interfere with this study
* Individuals with progressive radiating pain with motor-sensory changes (including weakness or numbness) related to their presenting pain complaint
* Any contra-indication to the use of electrical stimulation, including history of epilepsy, cardiac arrhythmias, pacemaker or any other implantable programmable device
* Treatment with acupuncture or auricular therapy within the last 3 months

Primary outcomes:
measure: Primary musculoskeletal pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Musculoskeletal pain related to co-morbities
timeFrame: 12 weeks
measure: Return of functional ability
timeFrame: 12 weeks
measure: Reduction of pain medication use
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San DIego
state: California
Study officials:
affiliation: Scripps Integrative Medical Center, La Jolla, CA
name: Robert Bonakdar, MD
role: PRINCIPAL_INVESTIGATOR
References: