Home > Riviste > European Journal of Physical and Rehabilitation Medicine > Fascicoli precedenti > Articles online first > European Journal of Physical and Rehabilitation Medicine 2017 Dec 21

ULTIMO FASCICOLO
 

ARTICLE TOOLS

Publication history
Estratti
Per citare questo articolo

EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE

Rivista di Medicina Fisica e Riabilitativa dopo Eventi Patologici


Official Journal of the Italian Society of Physical and Rehabilitation Medicine (SIMFER), European Society of Physical and Rehabilitation Medicine (ESPRM), European Union of Medical Specialists - Physical and Rehabilitation Medicine Section (UEMS-PRM), Mediterranean Forum of Physical and Rehabilitation Medicine (MFPRM), Hellenic Society of Physical and Rehabilitation Medicine (EEFIAP)
In association with International Society of Physical and Rehabilitation Medicine (ISPRM)
Indexed/Abstracted in: CINAHL, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,827


eTOC

 

European Journal of Physical and Rehabilitation Medicine 2017 Dec 21

DOI: 10.23736/S1973-9087.17.04923-1

Copyright © 2017 EDIZIONI MINERVA MEDICA

lingua: Inglese

Efficacy and safety of a fixed combination of intramuscular diclofenac 75 mg + thiocolchicoside 4 mg in the treatment of acute low back pain. A phase III, randomized, double blind, controlled trial

Egidio SPROVIERO 1 , Emilio ALBAMONTE 2, Cosimo COSTANTINO 3, Attilio GIOSSI 4, Maurizio MANCUSO 5, Alberto RIGAMONTI 6, Paolo TORNARI 4, Giuseppe CAGGIANO 7

1 ASL Potenza, Hospital of Lauria, Potenza, Italy; 2 ASP Potenza, Lauria, Potenza, Italy; 3 Azienda Ospedaliera-Universitaria di Parma, Parma, Italy; 4 Agenzia di Tutela della Salute (ATS) dell'Insubria, Porlezza, Como, Italy; 5 Agenzia di Tutela della Salute (ATS) dell'Insubria, Como, Italy; 6 Agenzia di Tutela della Salute (ATS) dell'Insubria, Alzate Brianza, Como, Italy; 7 ASL Potenza, Episcopia, Potenza, Italy


PDF  


BACKGROUND: The management of acute low back pain (LBP) is directed to obtain early and maximum relief of the local and regional pain, and to improve mobility and physical function.
AIM: To evaluate the effects of a 4 ml-volume diclofenac 75mg/thiocolchicoside 4mg fixed dose combination (FDC) for intramuscular (IM) injection (test) compared to the separate injection of the two components (reference).
DESIGN: Phase III, randomized, controlled, double-blind (blind-observer), parallel-group.
SETTING: Twenty-two General Practitioners in Italy.
POPULATION: Adult outpatients with acute moderate-severe LBP at rest (≥50mm at VAS) and stable muscle contracture (increase <5 cm in the distance between the two fingers of the examiner in the Schober test).
METHODS: Eligible patients were randomised to the test (N=111) or reference (N=112) treatment, both given IM once daily for 5 days. The primary efficacy endpoint of the study was the change from baseline in pain VAS score (0-100mm) measured at rest 96±2 hours (Day 5) from the start of treatment, one hour after the last injection.
RESULTS: Pain VAS score markedly improved in both groups and the test was non-inferior to the reference in primary endpoint, i.e. the upper bound of the 95% confidence interval of the adjusted difference was lower than the pre-specified limit of 4mm. There were no statistically significant differences between groups for improvements of pain measured at all time points before and one hour after injection, time to resolution of pain, improvements from baseline of muscle contracture, and time to first resolution of muscle contracture. Approximately 20% of patients in the two groups used rescue paracetamol for pain relief. Both the test and the reference treatment were well tolerated in terms of adverse effects, laboratory parameters and vital signs.
CONCLUSIONS: A 5-day treatment with IM diclofenac+thiocolchicoside FDC in a 4-ml volume was as effective and well tolerated as the separate injection of the two components in improving pain symptoms in patients with acute moderate-severe LBP.
CLINICAL REHABILITATION IMPACT: The new diclofenac+thiocolchicoside FDC formulation may allow treating effectively acute LBP while reducing the number of injections and hence the risk of local adverse reactions, and improving the patient’s compliance.


KEY WORDS: Diclofenac - Thiocolchicoside - Fixed dose combination - Acute low back pain

inizio pagina

Publication History

Article first published online: December 21, 2017
Manuscript accepted: December 20, 2017
Manuscript revised: December 19, 2017
Manuscript received: July 24, 2017

Per citare questo articolo

Sproviero E, Albamonte E, Costantino C, Giossi A, Mancuso M, Rigamonti A, et al. Efficacy and safety of a fixed combination of intramuscular diclofenac 75 mg + thiocolchicoside 4 mg in the treatment of acute low back pain. A phase III, randomized, double blind, controlled trial. Eur J Phys Rehabil Med 2017 Dec 21. DOI: 10.23736/S1973-9087.17.04923-1

Corresponding author e-mail

esmercure@tiscali.it