Postoperative residual neurological symptoms of degenerative diseases of the lower lumbar spine
Conditions
Interventions
Limapros group:NA
Methylcobalamin group:NA
Sponsors
Chinese 960th Hospital of the Joint Logistics Support Force of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old, male or female; 2) Patients with degenerative diseases of the lower lumbar spine diagnosed by clinical and imaging (medical history, physical examination and imaging examination); 3) After 3 months or more of conservative treatment (including medication, physiotherapy and injection therapy), the patient's clinical symptoms did not improve; 4) Must undergo single-segment lower lumbar degenerative decompression surgery; 5) The patient or his/her guardian voluntarily signs the informed consent form; 6) Patients must be followed up for at least 6 months.
Exclusion criteria
Exclusion criteria: 1) Ischemic lesions of the lower extremities caused by other causes, such as diabetes and vascular occlusive diseases; 2) Known or suspected hypersensitivity or intolerance to limatoprost or erecoxib and alphadextrix, other pharmaceutical excipients; 3) evidence or history of bleeding disorders, bleeding tendencies, bleeding constitutions or coagulation disorders; 4) Congestive heart failure, unstable angina (angina symptoms at rest) or myocardial infarction with greater severity than New York Heart Association Class II.; 5) ventricular arrhythmias or uncontrolled hypertension (systolic blood pressure = 140mmHg or diastolic blood pressure =90mmHg) requiring treatment with antiarrhythmic drugs; 6) pregnant women, lactating women, or women planning to become pregnant during the trial, as well as male and female patients with childbearing potential who are unwilling to use effective contraceptive methods or abstinence during the study; 7) Patients had abnormal liver and kidney function indicators within 1 month prior to enrollment, that is, the following results of any of the following laboratory tests: a) aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); b) alanine aminotransferase (ALT) > 3 times the upper limit of normal value (ULN); c) serum creatinine (Cr) > 3 times the upper limit of normal value (ULN); 8) any disease that is unstable or may jeopardize the safety and compliance of patients; 9) Those who have undergone lumbar spine surgery in the past; 10) Have participated in other clinical trials within 3 months before enrollment; 11) other diseases or conditions that the investigator deems inappropriate to participate in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of residual neurological symptoms at 3 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of residual neurological symptoms at 6 months postoperatively;JOA scores at 5 weeks, 9 weeks, March, and June after surgery;VAS scores at 5 weeks, 9 weeks, March, and June after surgery;Oswestry Dysfunction Index questionnaire scores at 5 weeks, 9 weeks, March, and June after surgery;Baseline and last follow-up SF-36 Quality of Life Questionnaire scores;Incidence of adverse events during various treatment periods; treatment cost; | — |
Countries
China
Contacts
Public ContactHuang Weimin
Chinese 960th Hospital of the Joint Logistics Support Force of the People's Liberation Army
Outcome results
None listed