Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy
Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Jul 13, 2015
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
Study Design
The study will be designed to meet CONSORT guidelines. A randomized placebo controlled trial will be carried out at the Physiotherapy Department of Connolly Hospital, Blanchardstown, Dublin 15. The study will be conducted on patients who present to the department with a diagnosis of Achilles tendinopathy. The diagnosis will be confirmed based on a history of an insidious onset of Achilles tendon pain, a tender nodule/thickening of the tendon to the region 2 to 6cm from the calcaneal insertion, and an ultrasound examination that excludes a frank tear.
Participants will be rand...
Gender
ALL
Eligibility 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
About Royal College Of Surgeons, Ireland
The Royal College of Surgeons in Ireland (RCSI) is a prestigious educational and research institution dedicated to advancing surgical practice and healthcare through innovative research, education, and clinical excellence. As a clinical trial sponsor, RCSI plays a pivotal role in conducting cutting-edge research that aims to improve surgical outcomes and patient care. With a commitment to fostering collaboration among healthcare professionals, researchers, and industry partners, RCSI is at the forefront of developing evidence-based interventions and therapies that address critical health challenges. Through its rigorous scientific approach and adherence to ethical standards, RCSI strives to contribute significantly to the advancement of medical knowledge and the enhancement of surgical practices globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dublin, , Ireland
Patients applied
Trial Officials
Helen French, PhD
Study Director
Royal College of Surgeons, Ireland
Trevor Duffy, MD, MBA
Study Director
Connolly Hospital, Dublin 15, Ireland
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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