Acupuncture for Functional Constipation in Older Adults

Not Applicable

Completed

• Conditions: Constipation - Functional
• Interventions: Device: sham acupuncture; Device: acupuncture

• Registration Number: NCT05496543
• Lead Sponsor: Yin Ping

Brief Summary

Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".

Detailed Description

Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-10-10
• Primary Completion: 2024-03-01
• Study Completion: 2024-09-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
• No gender restriction, age 60-80;
• FC that is classified as mild or moderate;
• Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
• Have not participated in other medical clinical trials over the past one month;
• Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment;
• Sign the informed consent.

Exclusion Criteria

• Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
• Constipation caused by organic diseases;
• Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
• Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
• Patients with cognitive impairment or aphasia;
• Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture group	sham acupuncture	Participants will receive sham acupuncture treatment on bilateral sham Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) that match real acupuncture points. The duration of needle retention, treatment period, and follow-up in the control group is the same as that in the intervention group.
Acupuncture group	acupuncture	Participants will receive acupuncture treatment at Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) bilaterally. Each treatment will last 30 minutes and participants will receive the treatment 3 times per week (every other day) for 8 weeks, 24 sessions in total. Follow-up time is week 4 and week 12 after treatment (ie, week 12 and week 20).

Primary Outcome Measures

Name	Time	Method
The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period	At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).	Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation-Symptoms (PAC-SYM)	At baseline and at week 8 (end of treatment).	A scale to assess the condition of the patient's constipation-related symptoms
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)	At baseline and at week 8 (end of treatment).	A brief but comprehensive assessment of the daily life quality of patients with FC, containing 28 items
Self-rating Anxiety Scale（SAS）	At baseline and at week 8 (end of treatment).	A measure of somatic symptoms associated with anxiety reactions.
Self-rating Depression Scale（SDS）	At baseline and at week 8 (end of treatment).	A self-rating scale to assess patients' depression
Weekly usage of emergency bowel medications	At baseline and at week 8 (end of treatment).	The proportions of participants using medications and doses for emergency treatment
Bristol Stool Scale	At baseline and at week 8 (end of treatment).	A scale to classify the patient's voluntary bowel movement stool.
Incidence of adverse events	During 1-8 weeks	The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.

Trial Locations

Locations (1)

Longhua Hospital; 🇨🇳 Shanghai, China