Battlefield Acupuncture for Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS).
研究概览
简要总结
The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on outcomes for pain, sleep, and physical activity level in an active duty military sample with subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that lasts more than 12 weeks.
Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as compared to placebo.
Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity using BFA as compared to placebo.
Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as compared to placebo.
The secondary study aims are:
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To explore the effects of BFA two weeks following the treatment for LBP.
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Do positive outcomes appreciated with BFA persist over two weeks?
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What is the pain medication usage during and after intervention treatments?
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To explore the effectiveness of BFA on trunk flexion mobility and balance.
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Does pain reduction improve trunk flexion and balance?
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Does improved truck flexion mobility and balance contribute to increased physical activity?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of LBP (pain for > 4 weeks, with or without radiating nerve pain
- •Age 18 to 50 years
- •Active duty military, Public Health Service, or Coast Guard (guard and reserve on active orders)
- •Pain score 3/10 or higher as patient reported on the DVPRS
- •mODI score ≥ 20%
- •No anticipated prolonged temporary duty, deployment, or vacation within the next month.
排除标准
- •Any severe comorbidity
- •LBP neurologic "red flags" indicating serious spinal pathology (i.e. bowel or bladder dysfunction)
- •Auricular acupuncture in the past 6 months
- •Use of steroids in the month prior to the study
- •Hemorrhagic disorders
- •Malignancy
- •Unexplained weight loss
- •Severe scoliosis or congenital spine disorder
- •Back pain because of a visceral problem (e.g. endometriosis)
- •Under surgeon's care for back surgery within the last 12 months
- •Balance disorder
- •Pregnancy or suspected pregnancy (last menstrual period will be reported by the patient)
- •Aversion to needles
- •Previous keloid scar formation
- •Active infection on the ear
- •Bleeding disorder
- •Metal allergy
- •Mental health diagnosis requiring medication (depression, PTSD, etc)
- •Untreated sleep apnea or other sleep disorders
结局指标
主要结局
Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS).
时间窗: The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
Participant reported pain level using the DVPRS. DVPRS pain level ranks from 0 (no pain) to 10 (As bad as it can be. Nothing else matters).
次要结局
- Change in sleep quality(The ESS and ISI will be administered weekly for seven times. Followed by a one time washout 2 weeks later. The Actigraph watch is worn the entire 8 weeks.)
- Change in pain medication need.(A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later.)
- Change in balance(The FRT and TUG will be administered weekly for seven times. Followed by a one time washout 2 weeks later. If the participant has a DVPRS >=2 and mODI >=20%, the FRT and TUG will also be measured after the intervention.)
- Change in physical activity(The mODI will be administered weekly for seven times. Followed by a one time washout 2 weeks later. The Actigraph watch is worn the entire 8 weeks.)
- Change in trunk flexion.(Trunk flexion will be administered weekly for seven times. Followed by a one time washout 2 weeks later. If the participant has a DVPRS >=2 and mODI >=20%, trunk flexion will also be measured after the intervention.)
研究者
David Wilson
Research Coordinator
The Geneva Foundation