Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy
NCT02499484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2019-06-06
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.
Conditions
- Tendinopathy
- Achilles Tendon Pain
Interventions
- DRUG
-
glyceryl trinitrate
Topical GTN will be used daily in combination with a eccentric home exercise program
- OTHER
-
Placebo ointment
Topical placebo ointment will be used in combination with a eccentric home exercise program
- OTHER
-
Eccentric exercise program
All participants will complete the eccentric exercise program as a home exercise program daily.
Sponsors & Collaborators
-
Health Research Board, Ireland
collaborator OTHER -
Royal College of Surgeons, Ireland
lead OTHER
Principal Investigators
-
Helen French, PhD · Royal College of Surgeons, Ireland
-
Trevor Duffy, MD, MBA · Connolly Hospital, Dublin 15, Ireland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2018-11-30
- Completion
- 2018-11-30
Countries
- Ireland
Study Locations
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