Acupuncture Therapy for Treatment of Musculoskeletal Pain

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.

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