Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Cleveland Constipation Score（CCS）
研究概览
简要总结
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
详细描述
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group
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.
干预措施: Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve (Device)
control group
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.
干预措施: Oral Mosapride Tablets (Drug)
结局指标
主要结局
Changes in Cleveland Constipation Score（CCS）
时间窗: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
Changes in the score of Bristol fecal trait scale
时间窗: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Guoliang Wu
Principal Investigator
Qianfoshan Hospital