Acupuncture for Functional Constipation in Older Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Device: acupuncture
* Device: sham acupuncture


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>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<br>* 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.<br>|
| Placebo Comparator: Sham acupuncture group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bristol Stool Scale | A scale to classify the patient's voluntary bowel movement stool. | At baseline and at week 8 (end of treatment). | 
| 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). | 
| 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). | 
| Self-rating Anxiety Scale（SAS） | A measure of somatic symptoms associated with anxiety reactions. | At baseline and at week 8 (end of treatment). | 
| Self-rating Depression Scale（SDS） | A self-rating scale to assess patients' depression | At baseline and at week 8 (end of treatment). | 
| 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). | 
| Incidence of adverse events | The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment. | During 1-8 weeks |