BMC Musculoskeletal Disorders | |
A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain | |
Research Article | |
Elias Zintzaras1  Clio Mavragani2  Stavros Tsilikas3  Konstantinos Iliopoulos4  Kyriakos Avramidis5  Antonios Tsagkalis6  Panagiota Koufaki7  | |
[1] BECRO, Athens, Greece;Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece;Pharmacology & Drug Development Program, Sackler School of Graduate Biomedical, Tufts University School of Medicine, SciencesBoston, MA, USA;Department of Physiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece;Orthopaedic Department, Central Clinic of Athens, Athens, Greece;Orthopaedic Department, General Clinic “Eftychios Patsidis”, Larissa, Greece;Orthopaedic Department, General Hospital of Larissa, Larissa, Greece;Orthopaedic Department, IASO Thessaly, Larissa, Greece;WinMedica S.A, 1-3 Oidipodos Str., & Attiki Odos Turnoff 33-35, 15238, Chalandri, Athens, Greece; | |
关键词: Acute, Low back pain; Diclofenac; Thiocolchicoside; NSAID; | |
DOI : 10.1186/s12891-023-06599-0 | |
received in 2022-09-08, accepted in 2023-06-01, 发布年份 2023 | |
来源: Springer | |
【 摘 要 】
BackgroundNon-specific acute low back pain (LBP) is a common health problem that may be accompanied by muscle spasm and decreased mobility. The combination of non-steroidal anti-inflammatory drugs and muscle relaxants represents an advantageous therapeutic option, however, available data on their combined use are conflicting.This prospective, randomized, single-blind, two-parallel-group trial assessed the efficacy of a single intramuscular (IM) injection of the fixed-dose combination (FDC) diclofenac (75 mg)-thiocolchicoside (4 mg/4 ml) product (test treatment) compared to diclofenac (75 mg/3 ml) alone (reference treatment) for the symptomatic relief of acute LBP. Tolerability and safety were also assessed as secondary variables.MethodsOne hundred thirty-four patients were enrolled (safety population) and randomly allocated to the combination or single-agent regimen. Pain intensity and muscle spasm, assessed respectively by the patient-reported visual analogue scale and investigator-performed finger-to-floor distance test, were determined prior to the injection as well as 1 and 3 h post-injection in 123 patients (per-protocol population). The patients were blinded to treatment. Safety was assessed up to 24 h post-injection.ResultsThe test treatment was superior in both alleviating the pain intensity and reducing the finger-to-floor distance at both 1 (p < 0.01 and p = 0.023 respectively) and 3 h post-injection (p < 0.01). A higher percentage of patients experienced > 30% reduction in pain intensity at 1 and 3 h with the test treatment (p = 0.037 and p < 0.01 respectively). The corresponding VAS (SD) scores for the test treatment group were at baseline, 1 and 3 h post-injection 72.03 (± 11.72), 45.37 (± 16.28) and 31.56 (± 15.08) respectively and for the reference treatment group 65.20 (± 12.16), 48.98 (± 18.76) and 44.52 (± 17.33) respectively. No adverse effects were reported with the combination treatment, whereas two patients treated with diclofenac reported dizziness.ConclusionsThe FDC treatment is an effective and well-tolerated option for the symptomatic treatment of LBP. Clinical and patient-reported assessments confirmed that a single IM injection of FDC diclofenac-thiocolchicoside was more effective than diclofenac alone in conferring rapid and sustained improvement in mobility and pain intensity.Trial registrationEudraCT No: 2017–004530-29 Available at https://eudract.ema.europa.eu/ Registered 04 Dec 2017.
【 授权许可】
CC BY
© The Author(s) 2023
【 预 览 】
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