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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
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Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the frequency of complete spontaneous bowel movements (CSBM) | Complete spontaneous bowel movement (CSBM) refers to the number of times a patient can spontaneously defecate and feel completely discharged every week without taking remedial laxatives or manual assistance;Observation indicators are mainly based on the defecation record card provided by the patient. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Guoliang, M.D. | Contact | 8618264136209 | wuguoliang@sdfmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Pang jing, M.D. | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C062720 | mosapride |
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| 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. |
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| Changes in the frequency of spontaneous bowel movements (SBM) | Spontaneous bowel movement (SBM) refers to the number of times a patient spontaneously defecates per week, including feeling exhausted and feeling unable to defecate. Observation indicators are mainly based on the defecation record card provided by the patient. | 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 | The international constipation patient quality of life rating scale designed based on PROs is mainly a survey questionnaire for the quality of life of constipation patients. Patients are scored before and after treatment, and physicians collect and record their individual and total scores for physical discomfort, psychological discomfort, constipation related anxiety, and satisfaction with treatment. The score is 0-112 points, and the higher the score, the worse the quality of life. | 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 | The acupuncture operator records the adverse reactions of the patient after the acupuncture operation (such as dizziness, infection, pelvic organ and nerve damage, etc.). | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. |