- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263001
Acupuncture Therapy for Treatment of Musculoskeletal Pain
May 2, 2017 updated by: Paul J. Mills, University of California, San Diego
Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92134
- Naval Medical Center San Diego
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Auricular therapy for treatment of musculoskeletal pain
|
Active Comparator: Usual Care Only
Usual care therapy for treatment of musculoskeletal pain.
Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.
|
Usual care therapy consists of over-the-counter and prescribed pharmacotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Bonakdar, MD, Scripps Integrative Medical Center, La Jolla, CA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 3, 2014
First Submitted That Met QC Criteria
October 10, 2014
First Posted (Estimate)
October 13, 2014
Study Record Updates
Last Update Posted (Actual)
May 4, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2011.0119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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