A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- The Brief Pain Inventory-Short Form
研究概览
简要总结
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.
详细描述
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.
The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.
Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.
Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult cancer patients (≥18 years old), both male and female.
- •Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
- •All tumor groups, including metastatic patients.
- •Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
- •Must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period.
排除标准
- •Use of acupuncture within the previous six months.
- •Currently on or within one-month of active treatment (chemotherapy or radiation).
研究组 & 干预措施
Group Acupuncture
Group acupuncture sessions take place in a multipurpose room, with 3-6 participants, each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor.
干预措施: Acupuncture (Device)
Individual Acupuncture
Individual acupuncture sessions take place in a multipurpose room, privately each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor.
干预措施: Acupuncture (Device)
结局指标
主要结局
The Brief Pain Inventory-Short Form
时间窗: 6 weeks
The Brief Pain Inventory-Short Form (BPISF) is a widely used self-report measure, originally developed for cancer pain, which measures both pain severity and pain interference
次要结局
- The Profile of Mood States-Short Form(6 weeks)
- Pittsburg Sleep Quality Index(6 weeks)
- The Inventory of Socially Supportive Behaviours(6 weeks)
- The Functional Assessment of Cancer Therapy-General(6 weeks)
- The Functional Assessment of Cancer Therapy - Fatigue(6 weeks)
- Edmonton Symptom Assessment Scale(6 weeks)
- A Pain Visual Analog Scale(6 weeks)
- The European Quality of Life-5 Dimensions(6 weeks)
研究者
Linda E. Carlson
Professor, Department of Oncology
University of Calgary