Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Primary musculoskeletal pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary musculoskeletal pain
时间窗: 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.
次要结局
- Musculoskeletal pain related to co-morbities(12 weeks)
- Return of functional ability(12 weeks)
- Reduction of pain medication use(12 weeks)
研究者
Paul J. Mills
Professor
University of California, San Diego