Clinical trial NCT06156995: Deep Needling at Zhongliao Point to Stimulate the Sacral Nerve for the Treatment of Slow Transit Constipation
Official title: Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Keywords: Constipation
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
First posted: 2023-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 1. Observing the clinical efficacy of deep acupuncture at Zhongliao point to stimulate the sacral nerve in the treatment of slow transit constipation of the colon through changes in main research indicators such as defecation frequency, stool shape, and fecal weakness.
2. Clarify the technical focus and difficulties of deep needling at Zhongliao point to stimulate the sacral nerve in the treatment of colonic slow transit constipation, providing a basis for guiding clinical promotion and treatment.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Cleveland Constipation Score（CCS）
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
measure: Changes in the score of Bristol fecal trait scale
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Secondary outcomes:
measure: Changes in the frequency of complete spontaneous bowel movements (CSBM)
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
measure: Changes in the frequency of spontaneous bowel movements (SBM)
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
measure: Changes in the Quality of Life Scale (PAC-QOL) scores of patients with constipation
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
measure: Incidence of the adverse reactions
timeFrame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Pang jing, M.D.
role: PRINCIPAL_INVESTIGATOR
References: