Self-administered acupressure for chronic severe functional constipation: a study protocol for a randomized controlled trial

Not Applicable

Conditions: Functional Constipation

Registration Number: ITMCTR2000004116

Lead Sponsor: The Third Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Satisfaction of Rome IV Criteria for FC;
2) Two or fewer mean weekly Rome IV Criteria for more than 3 months;
3) Age between 18 and 65 years;
4) No administration of rescue medicine (glycerol or sorbitol anal enema) 48 hours before the trial or any medication for constipation before enrollment for at least 2 weeks;
5) No administration of any other therapy for constipation, such as acupuncture, acupressure, or biofeedback therapy, and no participation in any other trial in the previous 3 months;
6) Documented consent to participate in the whole study.

Exclusion Criteria

1) Constipation possibly caused by irritable bowel syndrome, or inflammatory or structural bowel diseases;
2) Constipation possibly caused by drugs or endocrine, metabolic, neurologic, or postoperative diseases;
3) Presence of tumors, severe cardiovascular, hepatic, renal diseases, or other severe diseases;
4) Inability to cooperate because of cognitive dysfunction, aphasia, mental disorders, or other illness;
5) Pregnant women, lactating women, or those who plan to get pregnant in the following 3 months;
6) Presence of abdominal aortic aneurysm or hepatosplenomegaly;
7) Skin lesions at the operating site of the acupoints.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the proportion of Complete spontaneous bowel movements more than or equal to 3 in week 3-10;

Secondary Outcome Measures

Name	Time	Method
Straining severity scores;the proportion of Complete spontaneous bowel movements more than or equal to 3 in week 11-18;The Bristol Stool Form Scale;spontaneous bowel movements;Patient assessment of constipation quality of life (PAC-QOL);