ORIGINAL ARTICLE A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL, COMPARING THE COMBINATION OF CAFFEINE, CARISOPRODOL, SODIUM DICLOFENAC AND PARACETAMOL VERSUS CYCLOBENZAPRINE, TO EVALUATE EFFICACY AND SAFETY IN THE TREATMENT OF PATIENTS WITH ACUTE LOW BACK PAI

Objective: To evaluate the efficacy and safety of the combina-tion of diclofenac, paracetamol, carisoprodol, and caffeine in the treatment of acute low back pain and lumboischialgia, compared to the efficacy and safety of cyclobenzaprine. Study design: Single-center, comparative, randomized, double-blind clinical trial. Method: Drugs were administered t.i.d. for a period of 7 days. Study population: 108 patients with a diagnosis of acute low back pain and lumboischialgia in the last 7 days were randomized, being included 54 patients in each group. Endpoints: The pri-mary efficacy endpoints selected for the study were the pain visual analog scale and the Roland-Morris questionnaire, the results of which were compared before and after treatment. The secondary endpoints were the patient’s and the investigator’s overall assess-ment of the treatment, as well as the use of the analgesic rescue medication. The safety criteria were the tolerability analysis, th