Research on precise diagnosis and treatment of cervical spondylotic myelopathy and construction of multidisciplinary collaboration platform

Phase 1

Recruiting

• Conditions: Mild or moderate cervical spondylotic myelopathy

• Registration Number: ITMCTR2000003824
• Lead Sponsor: Department of orthopedics, Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Signed informed consent form;
2. The patients who meet the diagnostic criteria belong to mild or moderate cervical spondylotic myelopathy;
3. Male or female aged 40-75 years;
4. The course of disease is more than 3 months;
5. Volunteer to receive the treatment (Yiqi Huayu tongsui granules or placebo drugs combined with Bokebao).
6. The patients didn't received glucocorticoids orally, intravenously, intramuscularly or in soft tissue 4 weeks before accepting the test drug.

Exclusion Criteria

1. Those who have participated in or are participating in other clinical researches in the past 3 months;
2. The patients who had been treated with regular non-surgical treatment for at least 6 months to no avail and had more severe symptoms;
3. The muscle strength decreased significantly in a short period of time, and the muscle strength was lower than grade III;
4. Patients with history of severe cervical trauma and cervical surgery;
5. Pregnant women, lactating women and psychopaths;
6. Patients with heart, liver, kidney or hematopoiesis impairment;
7. People who are allergic to various drugs;
8. Mentally or legally disabled;
9. Those who have a history of opioid analgesics, sedative hypnotics and alcohol abuse;
10. Patients with serious primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardio cerebrovascular system, nervous system, tuberculosis, vertebral deformity, malignant tumor and psychosis;
11. Those who do not read or write in Chinese.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DI;NDI;VAS;JOA;

Secondary Outcome Measures

Name	Time	Method
EMG;EMG;MRI Pfirrmann classification of cervical spine;