Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Patients' Reported Satisfaction with Acupuncture Services
研究概览
简要总结
The goal of this clinical research study is to learn if using acupuncture with or without electrical stimulation in cancer patients with high levels of pain can help to relieve the pain.
详细描述
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. The needles are placed in areas that are intended to help relieve pain. Electrical stimulation is often applied to the needles to improve the treatment effects. The procedure is designed to be comfortable and relaxing.
Acupuncture Sessions:
If you are found to be eligible to take part in this study, you will receive acupuncture sessions 1-3 times per week in the acupuncture clinic at M. D. Anderson. The number of sessions will depend on the type and location of the pain you may be experiencing.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body and/or ears where the needles will be placed. These points will be chosen based on the symptoms you are having at the time of treatment, the location of the pain, and the type of pain.
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin, the number of needles, and whether the needles are near or far from the areas of pain will vary from person to person, based on standard acupuncture procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, or the legal guardians of patients must have the ability to understand English, sign a written informed consent, and be willing to follow protocol requirements.
- •ECOG Performance Status of 0, 1, or
- •Pain score >/= 4 on the on a 0-10 NRS pain scale after all efforts have been attempted in the PMC to control pain.
排除标准
- •Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- •Deformities that could interfere with accurate acupuncture point location.
- •Known coagulopathy and taking any dose of warfarin (i.e., Coumadin) or heparin, including low molecular weight heparin (i.e., Lovenox). Patients may participate if they are taking Plavix, aspirin or other non-steroidal anti-inflammatory agents.
- •Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry as these patients may not be able to cooperative with this slightly invasive procedure or with the data collection process.
- •Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not lab work is drawn prior to beginning the acupuncture treatment will be left to the discretion of the referring physician. Patients with platelets <100,000 may participate with written approval from the attending physician.)
- •Planned changes in the pain medication regimen.
- •Women who are pregnant.
结局指标
主要结局
Patients' Reported Satisfaction with Acupuncture Services
时间窗: Derived from surveys completed by participating patients over 3 Years
次要结局
未报告次要终点