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Volume 14
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10.3390/jcm14248827
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Article

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

by
Ioannis Oikonomou
1,2,*,
Maria Panagiotopoulou
2,
Nikolaos Christopoulos
2,
Eleni Loukeri
2,
Georgios Christodoulakis
3,
Georgios Kountis
4,
Stamatios A. Papadakis
5,
Ioannis Chiotis
3,
Athanasios Georgokostas
3,
Nikolaos Garantziotis
4,
Christos Loukas
4,
Dimitrios Pallis
5,
Petros Nikolakakos
5 and
Yiannis C. Bassiakos
6
1
Department of Medicine, University of Patras, 26504 Rio, Greece
2
Verisfield Single Member S.A., 152 31 Halandri, Greece
3
Orthopaedic Department, Peiraiko Therapeftirio S.A., 185 34 Piraeus, Greece
4
5th Orthopaedic Department, KAT General Hospital, 145 61 Kifissia, Greece
5
2nd Orthopaedic Department, KAT General Hospital, 145 61 Kifisia, Greece
6
Department of Economic Sciences, National & Kapodistrian University of Athens, 105 59 Athens, Greece
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(24), 8827; https://doi.org/10.3390/jcm14248827 (registering DOI)
Submission received: 5 November 2025 / Revised: 5 December 2025 / Accepted: 10 December 2025 / Published: 13 December 2025
(This article belongs to the Special Issue Low Back Pain: Clinical Treatment and Management)
Versions Notes

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 + Thiocolchicoside 4 mg (FDC product, Test Group) or Diclofenac sodium 75 mg alone (Diclofenac monotherapy, Reference Group) via a single IM injection. The primary outcome was the change in patient-reported pain intensity using the Visual Analogue Scale (VAS) from baseline to 3 h post-dose. Key secondary outcomes included pain change at 1 h in the VAS, improvement in lumbar mobility (finger-to-floor distance test, FTF), the proportion of patients achieving >30% pain reduction, and the incidence of adverse events (AEs). Randomization was centralized and both investigators and patients were blinded to the treatment. Results: All 140 randomized patients completed the trial. At 3 h post-injection, the combination therapy produced a significantly greater mean pain reduction than monotherapy (41.52 mm vs. 28.13 mm on the 100 mm VAS; p < 0.0001). Superiority of the combination was already evident at 1 h post-dose (VAS reduction 27.61 mm vs. 20.40 mm; p = 0.0089). Lumbar flexion improved more with the combination at 3 h (mean FTF distance improvement 14.52 cm vs. 7.94 cm; p < 0.0001) and at 1 h (9.21 cm vs. 4.62 cm; p < 0.0001). A higher proportion of patients achieved >30% pain relief with the combination (45.7% vs. 27.2% at 3 h, p < 0.0001; 31.4% vs. 18.6% at 1 h, p = 0.0066). Only one mild, transient adverse event (headache) was reported in the combination group (1.4% of patients) and none in the diclofenac-only group. No serious AEs occurred. Conclusions: A single intramuscular dose of diclofenac plus thiocolchicoside provided faster, greater relief of acute LBP than diclofenac alone, without compromising safety. The combination therapy significantly reduced pain and muscle spasm-related mobility limitations within 1–3 h and was well tolerated. These results support the combined use of an NSAID and muscle relaxant as an effective and safe option for acute moderate-to-severe LBP management.
Keywords: low back pain; diclofenac; thiocolchicoside; combination therapy; muscle spasm; randomized trial; acute pain low back pain; diclofenac; thiocolchicoside; combination therapy; muscle spasm; randomized trial; acute pain

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MDPI and ACS Style

Oikonomou, I.; Panagiotopoulou, M.; Christopoulos, N.; Loukeri, E.; Christodoulakis, G.; Kountis, G.; Papadakis, S.A.; Chiotis, I.; Georgokostas, A.; Garantziotis, N.; et al. 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. J. Clin. Med. 2025, 14, 8827. https://doi.org/10.3390/jcm14248827

AMA Style

Oikonomou I, Panagiotopoulou M, Christopoulos N, Loukeri E, Christodoulakis G, Kountis G, Papadakis SA, Chiotis I, Georgokostas A, Garantziotis N, et al. 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. Journal of Clinical Medicine. 2025; 14(24):8827. https://doi.org/10.3390/jcm14248827

Chicago/Turabian Style

Oikonomou, Ioannis, Maria Panagiotopoulou, Nikolaos Christopoulos, Eleni Loukeri, Georgios Christodoulakis, Georgios Kountis, Stamatios A. Papadakis, Ioannis Chiotis, Athanasios Georgokostas, Nikolaos Garantziotis, and et al. 2025. "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" Journal of Clinical Medicine 14, no. 24: 8827. https://doi.org/10.3390/jcm14248827

APA Style

Oikonomou, I., Panagiotopoulou, M., Christopoulos, N., Loukeri, E., Christodoulakis, G., Kountis, G., Papadakis, S. A., Chiotis, I., Georgokostas, A., Garantziotis, N., Loukas, C., Pallis, D., Nikolakakos, P., & Bassiakos, Y. C. (2025). 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. Journal of Clinical Medicine, 14(24), 8827. https://doi.org/10.3390/jcm14248827

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