Acupuncture for Post Amputation Limb Pain: A Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
研究概览
简要总结
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.
详细描述
The purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in Phantom Limb Pain (PLP) and/or Residual Limb Pain (RLP) as measured by the Visual Analogue Scale (VAS) and the McGill Short Form Pain Questionnaire (SF-MPQ). Further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated.
Study participants will be randomized to one of three acupuncture treatments: Chinese Scalp Acupuncture, French Auricular Acupuncture, or a combination of both.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease
- •Amputees who have been cleared to begin prosthetic fitting
- •Phantom and/or residual limb pain reported must be >/= 3/10
- •Active duty military or dependent eligible for military benefit >/=18 years old
排除标准
- •Congenital limb absence
- •Pregnancy
- •Any skin changes on the ear or scalp that would preclude placement of acupuncture needles
- •Patients intubated and unable to give consent
- •Patients with traumatic brain injury (TBI) diagnosed as greater than mild
结局指标
主要结局
Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
Level (VAS) of PLP and/or RLP one hour post each treatment
Presence/absence and level of PLP and/or RLP two weeks after final treatment
次要结局
- Changes in medication regimen during treatment period and after final treatment
- Changes in sleep habits during treatment period and after final treatment
- Any change in phantom limb sensation (PLP) after final treatment
- Length of time for each treatment
- Any discomfort associated with each treatment
- Overall satisfaction at the end of the study