Original articles

Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic lateral epicondylosis

J A Paoloni¹, G A C Murrell¹, R M Burch², R Y Ang²

¹ Orthopaedic Research Institute, Sydney, Australia
² Cure Therapeutics, New York, USA

Dr Justin Paoloni, Orthopaedic Research Institute, 2nd Floor, 4 South St, Kogarah, 2217, Research And Education Centre, St George Hospital, Kogarah, Sydney, Australia, 2035; jpaoloni{at}bigpond.net.au, pao_26{at}hotmail.com

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.

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