Discogenic low back pain
Conditions
Interventions
High does group:Oral Celecoxib 400mg/day
Low does group:Oral Celecoxib 100mg/day
Very low does group:Oral Celecoxib 25mg/day
Vehicle group:Oral Celecoxib 0mg/day
Sponsors
The Third Hospital of Hebei Medical University
Eligibility
Sex/Gender
Male
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Patients with low back pain aged 30-50 years old; 2. Patients with low back pain for more than 2 months; 3. The subjects with positive physical examination; 4. The patients with Modic type I or II showed by lumbar MRI; 5. Lumbar thin CT scan showed that the porosity of endplate was 10% higher than the normal reference value (5-10 healthy volunteers of the same sex without low back pain were regarded as the normal reference value); 6. Patients with VAS score above 3; 7. Patients with ODI score above 30.
Exclusion criteria
Exclusion criteria: 1. The patients used NSAIDs for more than one week in recent 2 months; 2. Patients with spinal tumor or fracture; 3. Patients with scoliosis angle > 20 degrees; 4. Patients with severe lumbar disc herniation and prolapse of lumbar intervertebral disc oppressing nerve roots; 5. Patients with abnormal liver function (alt, AST >=2 ULN); 6. Patients with abnormal renal function (CR >=1.5 ULN); 7. Patients with abnormal coagulation function; 8. Patients with thrombotic disease and vasculitis; 9. Patients with cardiovascular diseases, such as angina pectoris, history of myocardial infarction, severe heart failure after coronary artery bypass grafting (CABG); 10. Patients with cerebrovascular history; 11. Patients with history of peptic ulcer and gastrointestinal bleeding; 12. Patients who are known to be allergic to sulfanilamide, those who are allergic to celecoxib or any other component of the drug (e.g., allergic reactions and severe skin reactions), and patients who have induced asthma, urticaria or other allergic reactions after taking aspirin or other NSAIDs including other cyclooxygenase-2 (COX-2) specific inhibitors. 13. Patients with mental illness, drug or alcohol dependence; 14. The patient is mentally incapacitated or unable to understand the requirements of participating in the study; 15. Patients who are considered unsuitable or have poor compliance by any other researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale;Oswestry Disability Index;PROMIS-29 score;Stauffer-Coventry score;Low back mobility and tenderness;Modic Change;Modified Pfirrmann classification;Thin CT scan of lumbar spine;Serum Total ALP;Serum P1NP;Serum ß-CTX;Serum 25-hydroxy vitamin D;Serum PGE-2 concentration;Serum COX-2 concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;blood routine examination;routine urine examination;Liver Function Tests;kidney function test;coagulation function test;Blood calcium;serium inorganic phosphorus;Electrocardiography; | — |
Countries
China
Contacts
Public ContactWenyuan Ding
The Third Hospital of Hebei Medical University
Outcome results
None listed