Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale of pain
研究概览
简要总结
To evaluate the effect of fumigation in conjunction with acupuncture for knee osteoarthritis, participators were collected from acupuncture and Chinese traumatology clinic at Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital. Participators were randomized into 3 groups, one for acupuncture with fumigation, one for acupuncture with diluted fumigation, one for acupuncture only.
详细描述
Patient population. Between June 2015 and November 2017, research subjects were recruited via poster display and clinician referral, to participate in a three-armed, randomized, controlled trial to be conducted in the Traumatology Department Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of knee diagnosed by X-ray films
- •According Ahlbäck System, more than stage1
- •The Visual Analogue Scale of pain over 20mm in 100mm
排除标准
- •The Visual Analogue Scale of pain less than 20mm in 100mm
- •Received injection or scope treatment over knees
- •Received more than 3 times of operation
- •With severe inflammation (including fever, fluid, pus, gout, Rheumatic arthritis, etc.)
- •With sever systemic diseases (including metastatic cancer, coronary artery disease, lung disease, etc.)
- •With history of skin problem after other thermal treatment
- •Under other experiments
- •Women with pregnant, breastfeeding or prepare for pregnancy
研究组 & 干预措施
Fumigation Full
Full Fumigation after acupuncture, 2 times per week, for 4 weeks.
干预措施: Fumigation (Other)
Fumigation 1/16
1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks.
干预措施: Fumigation (Other)
Acupuncture
Acupuncture only, 2 times per week, for 4 weeks.
干预措施: Acupuncture (Other)
结局指标
主要结局
Visual Analogue Scale of pain
时间窗: This numeric measure is assed and recorded pre and post intervention at each of the study protocols bi-weekly interventions over (4) weeks, for a maximum of (8) sessions and a total of (16) measurements per individual patient.
This scale is used to asses change in pain intensity between pre and post intervention measures and change against established baseline measures. Patients are asked to rate their pain by choosing a number along a horizontal line of fixed length (100mm). The number scale ranges from 0-10, with 0 representing 'no pain' and 10 being 'worst pain possible'.
次要结局
- Questionnaire(This questionnaire is administered and recorded after patients have been enrolled in the trial and prior to their first intervention to establish a baseline. At the completion of the protocol's full course of treatment, bi-weekly treatment over (4) weeks)