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Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic
J A Paoloni1, G A C Murrell, R M Burch
1Orthopaedic Research Institute, 2nd Floor, 4 South St, Kogarah, 2217, Research And Education Centre, St George Hospital, Kogarah, Sydney, Australia, 2035. jpaoloni@bigpond.net.au
Objective:
This study aimed to determine whether a new glyceryl trinitrate patch preparation is effective in treating chronic lateral epicondylosis.
Design:
Randomised double-blind controlled clinical trial.
Setting:
Private practice
Patients:
154 adult patients with chronic lateral epicondylosis were recruited, with 136 patients completing the trial.
Interventions:
8 weeks of glyceryl trinitrate patch application (dosages of 72 mg/24 h, 1.44 mg/24 h, and 3.6 mg/24 h), or placebo patch application.
Main Outcome Measures:
Subjective global assessment of change in elbow symptoms, patient-rated tennis elbow evaluation, visual analogue pain at rest, visual analogue pain with activity, visual analogue pain intensity, grip strength, and strength testing using the Orthopaedic Research Institute-Tennis Elbow Testing System.
Results:
At 8 weeks there was a significant decrease in elbow pain with activity in the glyceryl trinitrate 0.72 mg/24 h group compared with placebo (p = 0.04). There were no other significant differences.
Conclusions:
Continuous 1.25 mg/24 h topical glyceryl trinitrate treatment, when combined with daily exercise rehabilitation, has previously demonstrated efficacy in treating chronic lateral epicondylosis. There was significantly decreased elbow pain with activity at 8 weeks in the glyceryl trinitrate 0.72 mg/24 h group (p = 0.04). This short-term dose-ranging study did not demonstrate a treatment effect of a new topical glyceryl trinitrate patch in dosages of 1.44 mg/24 h or 3.6 mg/24 h, which conflicts with previous studies on topical glyceryl trinitrate treatment.
Trial Registration Number:
NCT00447928.