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

• Published in: British journal of sports medicine 2009-04, Vol.43 (4), p.299-302
• Main Authors: Paoloni, J A, Murrell, G A C, Burch, R M, Ang, R Y
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adolescent; Adult; Aged; Analgesics; Analgesics - administration & dosage; Angina pectoris; Biomechanics; Blood pressure; Chronic Disease; Clinical trials; Collagen; Dose-Response Relationship, Drug; Double-Blind Method; Elbow; Fainting; Fibroblasts; Headaches; Humans; Middle Aged; Musculoskeletal diseases; Nitric oxide; Nitroglycerin - administration & dosage; Nitroglycerin - adverse effects; Pain; Pain management; Patients; Placebo effect; Rehabilitation; Sports medicine; Studies; Tennis; Tennis Elbow - drug therapy; Tennis Elbow - rehabilitation; Treatment Outcome; Young Adult
• ISSN: 0306-3674; 1473-0480
• DOI: 10.1136/bjsm.2008.053108

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.