Acupuncture for Functional Constipation in Older Adults

Constipation - Functional Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496543
• Other study ID #: 21Y11923900
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: PING YIN
• Phone: 0086-18917561621
• Email: bingxue616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Device:
• acupuncture
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.
• sham acupuncture
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".

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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