Deep Needling at Zhongliao Point to Stimulate the Sacral Nerve for the Treatment of Slow Transit Constipation

NCT06156995 | Unknown

• 1 other identifier: GlWu
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve

Conditions

Constipation

Keywords

Constipation

Outcome Measures

Primary Outcomes (2)

• Changes in Cleveland Constipation Score（CCS）

  The Clinical Scoring Scale for Constipation Patients (CCS) is mainly a scoring standard for quantifying the severity of constipation. Its content mainly includes 8 items: frequency of defecation, difficulty in defecation, feeling of incomplete defecation, abdominal pain, defecation time, type of help needed, frequency of difficulty in resolving constipation every 24 hours, and duration of constipation. The score range is 0-30 points, and the higher the score, the more severe the constipation is.

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

• Changes in the score of Bristol fecal trait scale

  Type 1 is a separated hard mass, type 2 is a clump shape, type 3 is a dry and cracked sausage shape, type 4 is a soft sausage shape, type 5 is a soft mass, type 6 is a mud shape, and type 7 is a watery stool. Each patient is assigned a score of 1-7. The patient confirms their stool classification based on the Bristol fecal trait scale and records it.

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

Secondary Outcomes (4)

• Changes in the frequency of complete spontaneous bowel movements (CSBM)

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

• Changes in the frequency of spontaneous bowel movements (SBM)

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

• Changes in the Quality of Life Scale (PAC-QOL) scores of patients with constipation

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

• Incidence of the adverse reactions

  Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.

Study Arms (2)

Treatment group

EXPERIMENTAL

Using 0.30mm × 75mm millineedle (produced by Suzhou Medical Equipment Factory, Huatuo brand) deeply punctures the Zhongliao acupoint to reach the sacral nerve. The acupuncture needle is connected using the MuhiStim Sensor nerve stimulator produced by Pajunk in Germany. Connect the positive pole to the left Zhongliao hole and the negative pole to the right Zhongliao hole. The frequency, current, and pulse width of sacral nerve electrical stimulation are 2 Hz, 5mA, and 0.1 ms, respectively.Electroacupuncture stimulates the sacral nerve for 30 minutes, once a day, five times a week. After the treatment, rest for two days before starting the next treatment. Five sessions are considered as one course of treatment, with a total of four courses for four consecutive weeks.

Device: Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve

control group

ACTIVE COMPARATOR

Mosapride citrate tablets (produced by Lunan Beite Pharmaceutical Co., Ltd., with the national drug approval number H19990317), oral administration, 5mg once, three times a day, taken before meals. 5 days is one course of treatment, with 2 days of rest during the treatment period. The total treatment period is 4 weeks, with a total of 4 courses.

Drug: Oral Mosapride Tablets

Interventions

Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve DEVICE

Using 0.30mm × 75mm millineedle (produced by Suzhou Medical Equipment Factory, Huatuo brand) deeply punctures the Zhongliao acupoint to reach the sacral nerve. The acupuncture needle is connected using the MuhiStim Sensor nerve stimulator produced by Pajunk in Germany. Connect the positive pole to the left Zhongliao hole and the negative pole to the right Zhongliao hole. The frequency, current, and pulse width of sacral nerve electrical stimulation are 2 Hz, 5mA, and 0.1 ms, respectively.Electroacupuncture stimulates the sacral nerve for 30 minutes, once a day, five times a week. After the treatment, rest for two days before starting the next treatment. Five sessions are considered as one course of treatment, with a total of four courses for four consecutive weeks.

Treatment group

Oral Mosapride Tablets DRUG

Mosapride citrate tablets (produced by Lunan Beite Pharmaceutical Co., Ltd., with the national drug approval number H19990317), oral administration, 5mg once, three times a day, taken before meals. 5 days is one course of treatment, with 2 days of rest during the treatment period. The total treatment period is 4 weeks, with a total of 4 courses.

control group

Eligibility Criteria

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

You may qualify if:

• Meets the diagnostic criteria for Slow transit constipation deficiency of both qi and yin;
• Age 18-65 years old;
• I have not been treated with intestinal motility drugs in the past month.
• Those who have informed consent and voluntarily participate in signing an informed consent form, adhere to medical advice for treatment, and undergo regular follow-up visits.

You may not qualify if:

• Other Traditional Chinese Medicine Syndrome Differentiation Types of Constipation.
• Concomitant severe heart, lung, and kidney diseases, neurological diseases, and metabolic diseases;
• Discovering organic lesions such as colorectal cancer and colorectal hyperplasia through colonoscopy, abdominal pelvic CT, or barium enema;
• Patients with severe mental illness or mental illness or cognitive impairment.
• Children, pregnant women, lactating women, and pregnant women.
• Those who stop taking medication at will or use other medications on their own during treatment, do not follow medical advice for treatment, or have incomplete information that affects the judgment of results, safety, and efficacy.
• Have a history of abdominal surgery.
• History of needle sickness.
• People with a tendency to bleed.

Sponsors & Collaborators

• Guoliang Wu: lead
• Qianfoshan Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

mosapride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pang jing, M.D.

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu Guoliang, M.D.

CONTACT

8618264136209; wuguoliang@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)