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

NCT02499484 | Completed

• 1 other identifier: RCSI-1764
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• VISA A, Victoria Institute of Sport Assessment - Achilles

  The primary outcome will be the Victoria Institute of Sport Assessment, Achilles (VISA-A) scale, which measures the impact of Achilles tendinopathy on individuals' lifestyle. The VISA-A is a valid, reliable and user friendly self-report index of severity of Achilles tendinopathy (score 0 = worst, score 100 =perfect), can be easily administered in clinical practice (Robinson et al, 2001) and has been used as an outcome measure in other tendinopathy trials (Tumilty et al, 2012).

  Change from baseline in VISA A at week 6,12 and 24

Secondary Outcomes (9)

• Lower Extremity Functional Scale (LEFS)

  Baseline and week 6, 12 and 24

• Pain Detection Threshold, PDT using pressure algometry

  baseline and week 6, 12 and 24

• Ultra sound measure of Achilles thickness

  Baseline and week 6, 12 and 24

• Numeric Rating Scale (NRS) for pain

  Baseline and week 6, 12 and 24

• Star Excursion Balance Test (SEBT)

  baseline and week 6, 12 and 24

Study Arms (2)

GTN and eccentric exercises

ACTIVE COMPARATOR

Participants will complete a 12 week eccentric exercise program and use 0.5cm of glyceryl trinitrate ointment daily for 24 weeks

Drug: glyceryl trinitrate; Other: Eccentric exercise program

Placebo and eccentric exercises

PLACEBO COMPARATOR

Participants will use a placebo ointment with no active ingredient for 24 weeks and complete an eccentric exercise program for 12 weeks

Other: Placebo ointment; Other: Eccentric exercise program

Interventions

glyceryl trinitrate DRUG

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

Also known as: Percutol

GTN and eccentric exercises

Placebo ointment OTHER

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

Also known as: aqueous cream

Placebo and eccentric exercises

Eccentric exercise program OTHER

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

Also known as: Alfredson's eccentric exercise program

GTN and eccentric exercises; Placebo and eccentric exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of Achilles tendinopathy
• Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
• Subjects must be male or female, aged 18 years or above at Baseline
• Achilles pain of \>3 months or more
• Mid-portion Achilles tenderness and thickening on palpation
• Confirmation of the diagnosis upon Ultra-sound assessment, and ruling out of other pathologies (eg: ruptures)

You may not qualify if:

• Previous corticosteroid injection to the affected tendon in the past 3 months
• Symptoms of less than 3 months duration
• Previous use of topical GTN
• Current use of nitrates, eg: GTN spray, tablet, transdermal patch.
• Contra-indication to GTN therapy (see section 12.2.3)
• Current pregnancy, breastfeeding or planning pregnancy
• VISA-A score \> 80
• Previous surgery to the affected Achilles tendon
• Seronegative spondyloarthropathy with Achilles enthesitis
• Previous performance of a heavy load eccentric exercise program of the Achilles in the last 2 years
• Severe migraines which fail to respond to over the counter medication and require specific migraine management
• 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.
• Staff or students of Connolly Hospital, Blanchardstown

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

Connolly Hospital, Blanchardstown

Dublin, D15, Ireland

Location

Related Publications (9)

• Paoloni JA, Appleyard RC, Nelson J, Murrell GA. Topical glyceryl trinitrate treatment of chronic noninsertional achilles tendinopathy. A randomized, double-blind, placebo-controlled trial. J Bone Joint Surg Am. 2004 May;86(5):916-22. doi: 10.2106/00004623-200405000-00005.

  PMID: 15118032 BACKGROUND

• Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.

  PMID: 9617396 BACKGROUND

• Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.

  PMID: 11579069 BACKGROUND

• Tumilty S, McDonough S, Hurley DA, Baxter GD. Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):733-9. doi: 10.1016/j.apmr.2011.08.049.

  PMID: 22541305 BACKGROUND

• Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

  PMID: 10201543 BACKGROUND

• Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.

  PMID: 16596889 BACKGROUND

• Silbernagel KG, Gustavsson A, Thomee R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1207-17. doi: 10.1007/s00167-006-0150-6. Epub 2006 Jul 21.

  PMID: 16858560 BACKGROUND

• Silbernagel KG, Thomee R, Thomee P, Karlsson J. Eccentric overload training for patients with chronic Achilles tendon pain--a randomised controlled study with reliability testing of the evaluation methods. Scand J Med Sci Sports. 2001 Aug;11(4):197-206. doi: 10.1034/j.1600-0838.2001.110402.x.

  PMID: 11476424 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Helen French, PhD

  Royal College of Surgeons, Ireland

  STUDY DIRECTOR

• Trevor Duffy, MD, MBA

  Connolly Hospital, Dublin 15, Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 16, 2015
• Study Start: September 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 6, 2019

Record last verified: 2018-04

Locations

IE (1)