Accessible Acupuncture for the Warrior With Acute Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- David Moss
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change in Defense and Veterans Pain Rating Scale (DVPRS)
研究概览
简要总结
The objective of this study is to determine if auricular acupuncture and/or the acupuncture point governor vessel 26 (GV26) with manual tonification is superior to conservative management (NSAIDs) at reducing acute low back pain (less than 4 weeks in duration).
详细描述
The study will be a randomized control trial of Active Duty and DoD Beneficiaries aged 18 years or older with complaints of acute lower back pain (four weeks or less in duration). Subjects will be randomized into one of four study groups receiving either 1) NSAIDs only (naproxen 500mg by mouth twice a day as needed) or 2) acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) or 3) Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed) or 4) GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed). We seek to determine if acupuncture is superior to conservative management alone in treating acute low back pain (4 weeks or less in duration).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female Active Duty and DoD Beneficiaries aged 18 years or older.
- •Complaints of acute back pain (4 weeks or less in duration).
排除标准
- •Known history of underlying rheumatologic condition.
- •Chronic low back pain (greater than 4 weeks in duration).
- •Contraindications to NSAID use (including peptic ulcer disease, underlying coagulopathy, severe coronary artery disease, underlying renal disease, allergy, thrombocytopenia).
- •Red flag symptoms of low back pain (to include bowel or bladder incontinence, sudden onset sensorineural deficits, loss of sensation in the perineal region).
- •Requiring narcotic use to control symptoms.
- •Patients currently taking opioid medications.
- •pregnant, may be pregnant, or attempting to become pregnant
研究组 & 干预措施
Group 1 (NSAIDS only)
NSAIDs only (naproxen 500mg by mouth twice a day as needed)
干预措施: NSAIDS (Drug)
Group 2 (Acupuncture+GV26)
Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)
干预措施: NSAIDS (Drug)
Group 2 (Acupuncture+GV26)
Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)
干预措施: GV26 with manual tonification (Device)
Group 3 (Battlefield Acupuncture+NSAIDS)
Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)
干预措施: NSAIDS (Drug)
Group 3 (Battlefield Acupuncture+NSAIDS)
Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)
干预措施: Battlefield Acupuncture (Device)
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed).
干预措施: NSAIDS (Drug)
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed).
干预措施: Battlefield Acupuncture (Device)
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed).
干预措施: GV26 with manual tonification (Device)
结局指标
主要结局
Change in Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
Number of days missed from work due to lower back pain.
时间窗: Post-treatment (Visit 2, 1 week followup)
The number of days missed from work is self-explanatory and will be treated as a parametric interval variable.
次要结局
未报告次要终点
研究者
David Moss
Principal Investigator
Mike O'Callaghan Military Hospital