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Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial

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单位: [1]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Inst Integrated Tradit Chinese & Western Med,Wuhan 430030,Hubei,Peoples R China [2]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Dept Neurol,Wuhan 430030,Hubei,Peoples R China [3]China Acad Chinese Med Sci, Inst Acupuncture & Moxibust, Beijing 100700, Peoples R China
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关键词: Acupuncture Functional constipation Study protocol

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Background: Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods: Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1: 1: 1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion: This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment.

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出版当年[2012]版:
大类 | 3 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2011]版:
Q2 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者单位: [1]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Inst Integrated Tradit Chinese & Western Med,Wuhan 430030,Hubei,Peoples R China
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