Acupuncture Therapy for Treatment of Musculoskeletal Pain

NCT02263001 | Completed DMC

• 1 other identifier: NMCSD.2011.0119
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

Auricular therapy; Acupuncture; Acute, sub-acute pain; Auricular Acupuncture Needles

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Musculoskeletal pain related to co-morbities

  12 weeks

• Return of functional ability

  12 weeks

• Reduction of pain medication use

  12 weeks

Study Arms (2)

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.

Other: Auricular acupuncture

Usual Care Only

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Auricular acupuncture OTHER

Auricular therapy for treatment of musculoskeletal pain

Auricular Acupuncture Plus Usual Care

Usual Care OTHER

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

Usual Care Only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active duty personnel with a musculoskeletal injury
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Scripps Center for Integrative Medicine: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (1)

Naval Medical Center San DIego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Robert Bonakdar, MD

  Scripps Integrative Medical Center, La Jolla, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 13, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)