Back to resultsAcupuncture Therapy for Treatment of Musculoskeletal Pain
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupuncture
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Musculoskeletal Pain focused on measuring Auricular therapy, Acupuncture, Acute, sub-acute pain, Auricular Acupuncture Needles
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
Sites / Locations
- Naval Medical Center San DIego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Auricular Acupuncture Plus Usual Care
Usual Care Only
Arm Description
Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy.
Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Musculoskeletal pain related to co-morbities
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
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
Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC.
Full Information
NCT ID
NCT02263001
First Posted
October 3, 2014
Last Updated
May 2, 2017
Sponsor
University of California, San Diego
Collaborators
Scripps Center for Integrative Medicine, United States Naval Medical Center, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02263001
Brief Title
Acupuncture Therapy for Treatment of Musculoskeletal Pain
Official Title
Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Scripps Center for Integrative Medicine, United States Naval Medical Center, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Auricular therapy, Acupuncture, Acute, sub-acute pain, Auricular Acupuncture Needles
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular Acupuncture Plus Usual Care
Arm Type
Experimental
Arm Description
Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy.
Arm Title
Usual Care Only
Arm Type
Active Comparator
Arm Description
Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.
Intervention Type
Other
Intervention Name(s)
Auricular acupuncture
Intervention Description
Auricular therapy for treatment of musculoskeletal pain
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care therapy consists of over-the-counter and prescribed pharmacotherapy
Primary Outcome Measure Information:
Title
Primary musculoskeletal pain
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Musculoskeletal pain related to co-morbities
Description
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.
Time Frame
12 weeks
Title
Return of functional ability
Description
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.
Time Frame
12 weeks
Title
Reduction of pain medication use
Description
Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bonakdar, MD
Organizational Affiliation
Scripps Integrative Medical Center, La Jolla, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San DIego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture Therapy for Treatment of Musculoskeletal Pain
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