CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
glyceryl trinitrate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02499484
NCT02499484N/ACompleted

The Use of Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy: a Randomized Placebo Controlled Trial

Royal College of Surgeons, Ireland·interventional·Posted Jul 16, 2015·Updated Jun 6, 2019

In Brief

A clinical study evaluating glyceryl trinitrate, Placebo ointment, and 1 other intervention for Tendinopathy and Achilles Tendon Pain. Completed, enrolled 76 participants across 1 site.

Detailed Summary

The primary objective of this research is to determine if the addition of topical GTN over 24 weeks to a 12 week exercise programme improves clinical outcomes more than placebo GTN for people with Achilles Tendinopathy. Pain in the Achilles tendon is a common condition seen by physiotherapists and doctors. It affects people involved in sports and those who are not. It can limit the ability to walk, hop, jump and run. If the pain persists for longer than 3 months it can become extremely difficult to abolish. As a result, people with this common condition can suffer from prolonged pain and often the pain will persist and affect everyday activities. While this is an easy injury to diagnose, it is not so easy to treat. Many treatments do exist, but often just provide short-term relief until the pain returns. Specific strengthening exercises have been shown to be beneficial in treating this condition. The current project will study Achilles tendon pain in Irish adults at Connolly Hospital, Dublin, and will take place from 2015 to 2019. In this study, there are two groups of patients. Both groups will perform an exercise program for 12 weeks. Physiotherapists will instruct them on how to perform the exercises. Each group will be given an ointment to place on the sore tendon using an applirule. This ointment will be applied daily for 6 months. One group will use an ointment containing nitroglycerin, the other group will use an ointment with no active ingredient. This is called a placebo. The patients will apply the ointment daily for 6 months. The patients will be assessed at the start of the program and after 6, 12 and 24 weeks. Our main question is to see whether this exercise program when combined with a nitroglycerin ointment applied directly over the sore tendon can improve the outcomes and recovery time for people who suffer with Achilles tendon pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartSep 1, 2016
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.0 years ago

Interventions

glyceryl trinitratedrug

Topical GTN will be used daily in combination with a eccentric home exercise program

Placebo ointmentother

Topical placebo ointment will be used in combination with a eccentric home exercise program

Eccentric exercise programother

All participants will complete the eccentric exercise program as a home exercise program daily.