The use of a patch with medication (called Glyceryl trinitrate) and an exercise program (called eccentric exercises) in the treatment of Achilles tendon pai

Phase 1

• Conditions: Achilles tendinopathy; MedDRA version: 18.1Level: LLTClassification code 10050471Term: Achilles tendon painSystem Organ Class: 100000004859; MedDRA version: 18.1Level: LLTClassification code 10050129Term: Achilles tendon thickeningSystem Organ Class: 100000004859; MedDRA version: 18.1Level: LLTClassification code 10000435Term: Achilles tendon injurySystem Organ Class: 100000004863; MedDRA version: 18.1Level: LLTClassification code 10000433Term: Achilles tendinitisSystem Organ Class: 100000004859; MedDRA version: 18.1Level: LLTClassification code 10000441Term: Achilles tendonitisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-005421-40-IE
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-07
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Current diagnosis of Achilles tendinopathy
2. 18 years of age and old
3. Achilles pain of 3 months or more
4. Mid-portion Achilles tenderness and thickening on palpation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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 for Achilles tendinopathy
4.Contra-indication to GTN therapy
5.Current pregnancy, breastfeeding or planning pregnancy
6.VISA-A score > 80
7.Previous surgery to the affected Achilles tendon
8.Seronegative spondyloarthropathy with Achilles enthesitis
9.Previous performance of a heavy load eccentric exercise program of the Achilles in the last 6 months
10.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.
11.Staff or students of Connolly Hospital, Blanchardstown.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified