Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic lateral epicondylosis.
OBJECTIVE
This study aimed to determine whether a new glyceryl trinitrate patch preparation is effective in treating chronic lateral epicondylosis.


METHODS
Randomised double-blind controlled clinical trial.


METHODS
Private practice


METHODS
154 adult patients with chronic lateral epicondylosis were recruited, with 136 patients completing the trial.


METHODS
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.


METHODS
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.


BACKGROUND
NCT00447928.
Paoloni
J A
JA
Orthopaedic Research Institute, 2nd Floor, 4 South St, Kogarah, 2217, Research And Education Centre, St George Hospital, Kogarah, Sydney, Australia, 2035. jpaoloni@bigpond.net.au
Murrell
G A C
GA
Burch
R M
RM
Ang
R Y
RY
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000009:adverse effects; D013716:Tennis Elbow / Q000188:drug therapy* / Q000534:rehabilitation; D016896:Treatment Outcome; D055815:Young Adult
D000700:Analgesics; D005996:Nitroglycerin