Efficacy of Acupuncture for Female With Non-cyclic Chronic Pelvic Pain: a Three-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- The change from baseline of the mean score in the past week of the Visual Analogue Scale
研究概览
简要总结
Chronic pelvic pain (CPP) is one of the common symptoms of women at childbearing age. The aim of this study is to assess the efficacy of acupuncture for female with non-cyclic chronic pelvic pain. A three-arm randomized controlled trial (RCT) using acupuncture, sham acupuncture and waiting list with a total sample of 150 will be conducted.
详细描述
Chronic pelvic pain (CPP) is a persistent pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months. According to a WHO epidemiological study, the worldwide prevalence rate of CPP in childbearing age women was 2.1%-24%. At present, nearly 55% of the patients had unclear etiology, and there is no universally accepted diagnosis, evaluation and treatment. CPP is often associated with gynecological and non gynecological diseases, including endometriosis, abdominal visceral adhesion, myofascial pain and dysfunction, irritable bowel syndrome and interstitial cystitis/bladder pain syndrome. CPP are also accompanied by psychological and physiological dysfunction, the most common is depression and anxiety, which seriously affects the quality of life of patients.
Acupuncture may have effect on non-cyclic CPP in female, however, there is a lack of evidence of effectiveness of acupuncture. A multi-center randomized three-armed controlled trial will be conducted. The aim of this study is assess the efficacy and safety of acupuncture for female patients with non-cyclic CPP.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants in the acupuncture and sham acupuncture will be blinded.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of non-cyclic CPP.
- •Age 18 to 50 years.
- •Have moderate to severe pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months.
- •The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40 scores.
- •Sign informed consent and participate in the study voluntarily.
排除标准
- •Have endometriosis (including adenomyosis), ovarian cyst (larger than 3cm), hysteromyoma (larger than 3cm), severe pelvic adhesion, pelvic malignant tumor (relevant examination must be within the last 6 months).
- •Have acute pelvic/urinary tract infection.
- •Have pain after pelvic surgery.
- •Have recurrent gastrointestinal or bladder diseases such as irritable bowel syndrome, interstitial cystitis / bladder pain syndrome, etc.
- •During pregnancy or in lactation or have a pregnancy plan within 8 months.
- •Have heart, lung, liver, kidney, mental disorders or cognitive dysfunction.
- •Have acupuncture treatment in recent 3 months.
结局指标
主要结局
The change from baseline of the mean score in the past week of the Visual Analogue Scale
时间窗: Week 6, 18 and 30
The scores of the Visual Analogue Scale range from 0 to 10，higher scores mean a worse outcome.
次要结局
- The change from baseline of the pain severity score of the Brief Pain Inventory(Week 6, 18 and 30)
- The change from baseline of the Pain Catastrophising Questionnaire score(Week 6, 18 and 30)
- The change from baseline of the Hospital Anxiety and Depression Scale score(Week 6, 18 and 30)
- The change from baseline of the World Health Organisation Quality of life - Bref Questionnaire score(Week 6, 18 and 30)
- The change from baseline of the pain interference score of the Brief Pain Inventory(Week 6, 18 and 30)
- The proportion of patients with decrease of 20% or more from baseline of the pain severity score of the Brief Pain Inventory(Week 6, 18 and 30)
- The change from baseline of the Brief Pain Inventory score(Week 6, 18 and 30)
- The proportion of patients with decrease of 0.6 score or more from baseline of the pain interference score of the Brief Pain Inventory(Week 6, 18 and 30)
- The proportion of subjects using rescue medications and the duration of medication use(Week 6, 18 and 30)
- The proportions of participants in each response category of the Patient global impression of change(Week 6, 18 and 30)
研究者
Liu Zhishun
Principle investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences