Acupuncture Therapy for Treatment of Musculoskeletal Pain

NCT ID: NCT02263001

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Auricular Acupuncture Plus Usual Care

Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy.

Group Type: EXPERIMENTAL

Auricular acupuncture

Intervention Type: OTHER

Auricular therapy for treatment of musculoskeletal pain

Usual Care Only

Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care therapy consists of over-the-counter and prescribed pharmacotherapy

Interventions

Auricular acupuncture

Auricular therapy for treatment of musculoskeletal pain

Intervention Type: OTHER

Usual Care

Usual care therapy consists of over-the-counter and prescribed pharmacotherapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Center for Integrative Medicine

OTHER

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Mills

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Bonakdar, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Integrative Medical Center, La Jolla, CA

Locations

Naval Medical Center San DIego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2011.0119

Identifier Type: -

Identifier Source: org_study_id