Efficacy of diclofenac in lateral epicondylitis of the elbow also treated with immobilization. The University of Montreal Orthopaedic Research Group
H. Labelle and R. Guibert
Division of Orthopaedics, Hopital Sainte-Justine, Universite de Montreal.
OBJECTIVE: To evaluate the efficacy of an oral nonsteroidal
anti-inflammatory drug in the treatment of lateral epicondylitis. DESIGN:
Multicenter double-blind randomized controlled trial in which the following
hypothesis was tested: whether diclofenac sodium provided a 20% or greater
improvement over rest and cast immobilization in the response rate to
treatment of lateral epicondylitis beyond and over rest in an experimental
group compared with a control group after 4 weeks of treatment. SETTING:
Recruitment from urban general practices and referrals to 4 university
hospitals. SUBJECTS AND METHODS: During a 1-year period, 206 subjects aged
18 to 60 years with lateral epicondylitis were recruited from the clientele
treated by family physicians. Thirty subjects refused to participate and 47
presented with exclusion criteria, leaving 129 subjects who entered the
study. One subject withdrew after 21 days. INTERVENTIONS: The experimental
group was treated with a daily dose of diclofenac sodium (150 mg) for 28
days, while the control group received a placebo during the same period. In
addition, both groups were immobilized in a cast for 14 days and were told
not to perform repetitive movements of the involved limb for 21 days. MAIN
OUTCOME MEASURES: Measuring instruments consisted of grip strength
measurements with a squeeze dynamometer, a visual analog pain scale, a
visual analog function scale, and an 8-item pain-free function index.
RESULTS: A statistically and clinically significant reduction of pain was
associated with treatment with diclofenac, but no clinically significant
difference in grip strength or functional improvement could be detected
between the 2 groups. Secondary effects (diarrhea and abdominal pain) were
significantly more frequent in the diclofenac-treated group. CONCLUSION:
Taking into account the limited improvement noted over rest and cast
immobilization and the number of associated adverse events, it is difficult
to recommend the use of diclofenac in the treatment of lateral
epicondylitis at the dosage used in this study.