Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Patients satisfactory for the treatment
研究概览
简要总结
To assess the application of partially randomized patient preference (PRPP) trial model which concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with fibromyalgia diagnosed according to criteria formulated by American College Rheumatology 2002;
- •Patients whose scores for pain intensity is more than 30mm;
- •Patients who are 20 to 60 years old;
- •Patients who fully understand the process of this research and who are willing to provide informed consent.
排除标准
- •The widespread muscular-skeletal pain is caused by some kind of disease, surgery, or other external interference factors (except fibromyalgia);
- •Patients with mental disorders, or other serious organic diseases, such as organ failure;
- •Patients who take oral anodyne medications or accept other interventions for pain relief during the treatment;
- •Pregnant or lactating women;
- •Patients currently participating in another clinical trial.
研究组 & 干预措施
Acupuncture (randomized)
Sterilize the selected points with alcohol, and then select the specific size of needles to do the acupuncture. Do the manual stimulation for seconds after needles' insertion, including twist, pull up and deeper insert. Needles should be withdrawn after 30 minutes.
干预措施: Acupuncture (Other)
Cupping therapy (randomized)
Use retained cupping as the main cupping method, supplemented with flash cupping and/or moving cupping. First use empty cupping, which means the cups are removed after suction without delay, then practitioners should control the suction by gently moving the cup toward direction of DU and/or BL, repeat this moving for several times, finally cupping practitioners utilize the flaming heating power to achieve suction (minus pressure) inside the cups to make them apply on the desired part of the body. Cups should retain for 10 minutes daily, patients accept the treatment three times weekly for totally 15 times.
干预措施: Cupping therapy (Other)
Cupping therapy (non-randomized)
Use retained cupping as the main cupping method, supplemented with flash cupping and/or moving cupping. First use empty cupping, which means the cups are removed after suction without delay, then practitioners should control the suction by gently moving the cup toward direction of DU and/or BL, repeat this moving for several times, finally cupping practitioners utilize the flaming heating power to achieve suction (minus pressure) inside the cups to make them apply on the desired part of the body. Cups should retain for 10 minutes daily, patients accept the treatment three times weekly for totally 15 times.
干预措施: Cupping therapy (Other)
Acupuncture (non-randomized)
Sterilize the selected points with alcohol, and then select the specific size of needles to do the acupuncture. Do the manual stimulation for seconds after needles' insertion, including twist, pull up and deeper insert. Needles should be withdrawn after 30 minutes. Patients accept the treatment three times weekly for totally 15 times.
干预措施: Acupuncture (Other)
结局指标
主要结局
Patients satisfactory for the treatment
时间窗: The satisfactory for the treatment is investigated at week 5 (as the end of the treatment).
Satisfactory for the treatment is measured by a seven-score scale, with 1 for "very satisfied" and 7 for "very unsatisfied".
Practitioners' attitude for the research model
时间窗: Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).
Individual interview or the focus group interview will be applied after the treatment, all the practitioners in the study (including acupuncturists and cupping therapy practitioners) will be interviewed to know their attitude for conducting the partially randomized patient preference trial model and their thoughts of this model compare to general randomized controlled trial.
Patients' compliance
时间窗: Record the number of drop out or lost during the 5 weeks' treatment and 3 months' follow up duration (for an expected totally 17 weeks) and note the reason for missing data
次要结局
- Adverse events(Adverse events will be observed for the duration of 5 weeks' treatment and 3 months' follow-up, with an expected average of totally 17 weeks.)
- Patients' expectation for the treatment(Patients' expectation is investigated at week 0)
- Visual Analogue Scale (VAS) for pain intensity(VAS should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively.)
研究者
Huijuan Cao
Research Associate
Beijing University of Chinese Medicine