Acupuncture for Functional Constipation in Older Adults

NCT05496543 | Completed DMC

• 1 other identifier: 21Y11923900
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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".

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period

  Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.

  At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).

Secondary Outcomes (7)

• Bristol Stool Scale

  At baseline and at week 8 (end of treatment).

• Patient Assessment of Constipation-Symptoms (PAC-SYM)

  At baseline and at week 8 (end of treatment).

• Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)

  At baseline and at week 8 (end of treatment).

• Self-rating Anxiety Scale（SAS）

  At baseline and at week 8 (end of treatment).

• Self-rating Depression Scale（SDS）

  At baseline and at week 8 (end of treatment).

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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).

Device: acupuncture

Sham acupuncture group

PLACEBO COMPARATOR

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.

Device: sham acupuncture

Interventions

acupuncture DEVICE

All acupoints will be routinely sterilized at first. After the insertion of the needles, manipulations of lifting, twirling, and thrusting are performed on all needles to reach de qi, which is a sensation typically associated with needling including soreness, numbness, swelling, heaviness, and other feelings. This is considered to be an important component of the therapeutic effect of acupuncture.

Acupuncture group

sham acupuncture DEVICE

The placebo needles chosen for this study are flat-tipped needles without a tip, which could not be pierced into the skin. In the meanwhile, an external patch device will fix the needles, which are visually pierced into the skin. After the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball so that the patient can feel the pulling out of the "needle".

Sham acupuncture group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yin Ping: lead
• Shanghai Municipal Hospital of Traditional Chinese Medicine: collaborator
• Longhua Hospital: collaborator

Study Sites (1)

Longhua Hospital

Shanghai, 200032, China

Location

Related Publications (3)

• Zhou K, Fang J, Wang X, Wang Y, Hong Y, Liu J, Wang L, Xue C, Wang P, Liu B, Zhu B. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011 Nov;17(11):1007-13. doi: 10.1089/acm.2010.0652. Epub 2011 Oct 14.

  PMID: 21999154 BACKGROUND

• Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.

  PMID: 32111187 BACKGROUND

• Dunstan DA, Scott N. Clarification of the cut-off score for Zung's self-rating depression scale. BMC Psychiatry. 2019 Jun 11;19(1):177. doi: 10.1186/s12888-019-2161-0.

  PMID: 31185948 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• PING YIN

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: October 10, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 30, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)