Clinical Trial: Acupuncture Therapy for Treatment of Musculoskeletal Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial

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 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, 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.
Sponsor: University of California, San Diego

Current Primary Outcome: Primary musculoskeletal pain [ Time Frame: 12 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Musculoskeletal pain related to co-morbities [ Time Frame: 12 weeks ]
    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.
  • Return of functional ability [ Time Frame: 12 weeks ]
    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.
  • Reduction of pain medication use [ Time Frame: 12 weeks ]
    Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC.


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: October 3, 2014
Date Started: April 2013
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017