Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal College of Surgeons, Ireland
• Collaborator: Health Research Board, Ireland
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

1. Current diagnosis of Achilles tendinopathy

2. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol

3. Subjects must be male or female, aged 18 years or above at Baseline

4. Achilles pain of >3 months or more

5. Mid-portion Achilles tenderness and thickening on palpation

6. Confirmation of the diagnosis upon Ultra-sound assessment, and ruling out of other pathologies (eg: ruptures)

Exclusion Criteria:

1. Previous corticosteroid injection to the affected tendon in the past 3 months

2. Symptoms of less than 3 months duration

3. Previous use of topical GTN

4. Current use of nitrates, eg: GTN spray, tablet, transdermal patch.

5. Contra-indication to GTN therapy (see section 12.2.3)

6. Current pregnancy, breastfeeding or planning pregnancy

7. VISA-A score > 80

8. Previous surgery to the affected Achilles tendon

9. Seronegative spondyloarthropathy with Achilles enthesitis

10. Previous performance of a heavy load eccentric exercise program of the Achilles in the last 2 years

11. Severe migraines which fail to respond to over the counter medication and require specific migraine management

12. Inability to perform the exercise program due to serious illness, such as unstable angina/blood pressure, myocardial infarction in past three months, cardiomyopathy, uncontrolled metabolic disease, recent ECG changes, advanced respiratory disease or third degree heart block.

13. Any medical or psychiatric condition that the investigator deems appropriate for exclusion

14. Staff or students of Connolly Hospital, Blanchardstown