One Needle Hand Acupuncture (Combined) With Movement for Treatment of Musculoskeletal Disorders: A Blinded Randomized Controlled Trial Involving 3 Groups
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The purpose of this research study is to study the method of acupuncture called one needle hand acupuncture, where a needle is placed just in your hand, in order to treat pain in various locations. Benefits of acupuncture will be studied over time to determine short and long term effects of acupuncture, and see how acupuncture may alter or modify a patient's disease process.
详细描述
Patients with neck, shoulder, low back, or hip pain that is exacerbated by movement will be randomized 1:1:1 to receive either verum hand acupuncture at the correct location (with or without movement) or control acupuncture at a nearby incorrect location. After needling and as part of the intervention, the movement groups will perform gentle active range of motion (ROM) exercises, while the without movement group will lay on the examination table, all for 10 minutes. Immediately pre- and post- intervention, numeric pain rating scores (NPRS) and goniometer- or inclinometer-obtained ROM measurements will be recorded for the most provocative movement plane.
In the physical therapy literature, within-session improvements in pain and ROM have been shown to correlate with between-session improvements.All patients will complete PROMIS Pain Interference, Physical Function, Anxiety, and Depression measures prior to the acupuncture intervention and then 1,2, 4, and 8 weeks later.
Four potential treatment response modifiers will be assessed. In Traditional Chinese Medicine (TCM), a strong needling sensation felt by the patient during an acupuncture treatment is called a "deqi" response and is thought to be a positive prognostic sign. In Western medicine, a local twitch response (LTR) observed during needling of muscle trigger points is thought to represent a polysynaptic reflex and has been linked to local pain improvements.Other potential modifiers include patients' underlying musculoskeletal structural diagnosis and the provider's experience performing acupuncture.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary pain localized to neck, shoulder, low back, hip.
- •Pain >=4 on Numeric Pain Rating Scale with one of predetermined motions.
- •Willing to participate in study and fill out questionnaires.
排除标准
- •Fracture, malignancy
- •Condition that requires urgent treatment (e.g. cervical myelopathy)
- •Contraindications to needling (e.g. pregnancy, active infection)
结局指标
主要结局
Change in Numeric Pain Rating Scale (NPRS)
时间窗: Pre-acupuncture, post-acupuncture + 10 minutes
Change in Numeric Pain Rating Scale from Baseline. Range is -10 to +6 by increments of 1. NPRS of later time point minus NPRS at baseline with lower number being better.
Percentage Change in Pain
时间窗: Immediately post-acupuncture, post-acupuncture + 10 minutes
Percentage Change in Pain after Needling Treatment. Options are 0%, 25%, 50%, 75%, 100%. Patient reported outcome at 2 time points with higher percentage indicating more improvement and being better.
次要结局
- Change in Total Arc of Motion(Pre-Acupuncture, post-acupuncture + 10 minutes)
