A Double-Blind Randomized Active-Controlled Trial Evaluating the Short-Term Efficacy of a Single Intramuscular Injection of a Fixed-Dose Combination Product Containing Diclofenac and Thiocolchicoside in Patients with Acute Moderate to Severe Low Back Pain.

ABSTRACT: Background/Objectives: Acute low back pain (LBP) is a prevalent cause of disability worldwide. If often involves both inflammation and reflex muscle spasm, suggesting combined therapy with a non-steroidal anti-inflammatory drug (NSAID) and a muscle relaxant may provide superior relief. This study aimed to evaluate the short-term efficacy and safety of a single intramuscular (IM) injection of a fixed-dose combination (FDC) product containing Diclofenac and Thiocolchicoside versus Diclofenac monotherapy in adults with acute LBP. Methods: We conducted a phase III multicenter, randomized, double-blind, parallel-group trial in 140 patients with acute LBP of moderate to severe intensity. Patients were allocated 1:1 to receive either the combination of Diclofenac sodium 75 mg + Thio

SUBMITTER: Oikonomou I 

PROVIDER: S-EPMC12733800 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature