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

Trials

Bing Zhu³  Xiang Hong Jing³  Wei Wang¹  Ming Min Zhang²  Ying Wang²  Xiao Hu Xu²  Guang Ying Huang²  Cui Hong Zheng² 

[1] Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China;Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China;Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China

关键词: Study protocol;    Functional constipation;    Acupuncture;   

Others  :  1092875
DOI  :  10.1186/1745-6215-14-344

 received in 2013-03-18, accepted in 2013-10-11,  发布年份 2013

【 摘 要 】

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.

Trial registration

ClinicalTrials.gov ID: NCT01274793.

【 授权许可】

   
2013 Zheng et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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