A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Pain Score
研究概览
简要总结
The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Bowen Therapy uses specific sequences of gentle cross-fibre moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body's healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Bowen Therapy is widely recognized and utilized worldwide for acute and chronic health conditions from new-born to the elderly, both mobilized and bed-ridden patients with no documented evidence to show it has caused any harm or adverse effects.
There are two study groups in this study and patients will be randomized and allocated to either one. One group (Control group) will continue receiving conventional treatment; while another group (Bowen group) will receive 8 sessions of Bowen therapy. The investigators hypothesize that Bowen Therapy is superior to the conventional pain treatment for patients with fibromyalgia.
详细描述
This study is going to look at the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. 80 patients with fibromyalgia attending pain management clinic will be recruited at Alice Ho Miu Ling Nethersole Hospital after informed consent. They will be randomized into either group (control group or Bowen group). Control group will continue receiving conventional treatment such as follow-ups by pain specialists, taking analgesia, physiotherapy. Bowen group will need to attend 8 sessions of therapy. All subjects will be evaluated at 12th week and 24th week after signing the consent.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
- Investigator will be blinded and responsible for obtaining informed consent.
- Outcome Assessor who will be responsible to perform the Endurance Strength Test (EST) and assist patients in completing questionnaires, will be blinded to measure the EST during the study period.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Widespread pain index (WPI) ≧7 and symptom severity (SS) scale score ≧5 or WPI between 3 and 6 with SS scale score ≧
- •The WPI includes evaluation of tender points at 19 regions. Tender point count (TPC) is examined by application of approximately 4 kg/cm2 pressure with the tip of the thumb on those regions.
- •Symptoms have been present at a similar level for at least 3 months.
- •Patient does not have any disorder that would otherwise explain the pain
- •Agrees to participate in the study and agree to discontinue other alternatives treatments except in conditions otherwise approved by the investigators.
排除标准
- •Patient refusal
- •pregnancy
- •assessed to be contraindicated to participate by pain specialists due to the presence of other co-morbidities or conditions
- •underlining disease that affect mobility of upper limb and lower limb
- •known severe psychiatric illness
- •known malignancy, skin disease, infectious disease, severe cardiovascular disease, patients taking anti-coagulants
- •enrolled in other studies
- •refuse to temporarily discontinue concurrent treatment or intervention as pain management during the study period e.g. alternative medicine, physiotherapy, chiropractor
结局指标
主要结局
Change of Pain Score
时间窗: 3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks)
The pain score in Numeric Rating Scale (0-10) for both groups of patients, which 0= no pain to 10=worst pain.
次要结局
- Change of 36-item Short form Survey (SF-36)(3 time points (0 week, 12th week and 24th week after obtaining consent))
- Jenkins Sleep Evaluation Questionnaire (JSEQ) for sleep(3 time points (0 week, 12th week and 24th week after obtaining consent))
- Change of Brief pain inventory-Short Form (BPI)(3 time points (0 week, 12th week and 24th week after obtaining consent))
- Change of Hospital anxiety and depression scale (HADS)(3 time points (0 week, 12th week and 24th week after obtaining consent))
- Change of Endurance strength test of lower extremities(3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks))
- Change of Endurance strength test of upper extremities(3 different time points that include before the study (0 week), the mid term (12th week) and end of the study (24th weeks))
研究者
Ms Pik Yu CHEN
Pain nurse (Registered Nurse)
Alice Ho Miu Ling Nethersole Hospital