Randomised, Double Blind, Placebo Controlled, Multicentre Dose-Ranging Clinical Trial of a New Topical Glyceryl Trinitrate Patch for Chronic Lateral Epicondylosis

Abstract

Objective: This study aimed to determine if 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: Eight weeks of glyceryl trinitrate patch application (dosages of 0.72 mg/ 24 hour, 1.44 mg/ 24 hour, and 3.6 mg/ 24 hour), 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 eight weeks there was a significant decrease in elbow pain with activity in the glyceryl trinitrate 0.72 mg/ 24 hour group compared with placebo (p=0.04). There were no other significant differences.

Conclusions: Continuous 1.25mg/ 24 hour 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 eight weeks in the glyceryl trinitrate 0.72 mg/ 24 hour 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 hour, and 3.6 mg/ 24 hour, and conflicts with previous studies on topical glyceryl trinitrate treatment.

US Food and Drug Administration Clinical Trial Registration Number: IND 72,568

Trial registered on www.clinicaltrials.gov : NCT00447928