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Acupuncture for Functional Constipation in Older Adults

Primary Purpose

Constipation - Functional

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

sham acupuncture

About this trial

This is an interventional treatment trial for Constipation - Functional

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Longhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture group

Sham acupuncture group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Bristol Stool Scale

A scale to classify the patient's voluntary bowel movement stool.

Patient Assessment of Constipation-Symptoms (PAC-SYM)

A scale to assess the condition of the patient's constipation-related symptoms

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

Self-rating Anxiety Scale（SAS）

A measure of somatic symptoms associated with anxiety reactions.

Self-rating Depression Scale（SDS）

A self-rating scale to assess patients' depression

Weekly usage of emergency bowel medications

The proportions of participants using medications and doses for emergency treatment

Incidence of adverse events

The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.

Full Information

NCT ID

NCT05496543

First Posted

August 9, 2022

Last Updated

October 25, 2022

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Shanghai Municipal Hospital of Traditional Chinese Medicine, Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05496543

Brief Title

Acupuncture for Functional Constipation in Older Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 10, 2022 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Shanghai Municipal Hospital of Traditional Chinese Medicine, Longhua Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation - Functional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture group

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

sham acupuncture

Intervention Description

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".

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Bristol Stool Scale

Description

A scale to classify the patient's voluntary bowel movement stool.

Time Frame