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

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ClinicalTrials.gov Identifier: NCT02499484
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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.


Condition or disease Intervention/treatment Phase
Tendinopathy Achilles Tendon Pain Drug: glyceryl trinitrate Other: Placebo ointment Other: Eccentric exercise program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy: a Randomized Placebo Controlled Trial
Study Start Date : September 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GTN and eccentric exercises
Participants will complete a 12 week eccentric exercise program and use 0.5cm of glyceryl trinitrate ointment daily for 24 weeks
Drug: glyceryl trinitrate
Topical GTN will be used daily in combination with a eccentric home exercise program
Other Name: Percutol

Other: Eccentric exercise program
All participants will complete the eccentric exercise program as a home exercise program daily.
Other Name: Alfredson's eccentric exercise program

Placebo Comparator: Placebo and eccentric exercises
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
Topical placebo ointment will be used in combination with a eccentric home exercise program
Other Name: aqueous cream

Other: Eccentric exercise program
All participants will complete the eccentric exercise program as a home exercise program daily.
Other Name: Alfredson's eccentric exercise program




Primary Outcome Measures :
  1. VISA A, Victoria Institute of Sport Assessment - Achilles [ Time Frame: Change from baseline in VISA A at week 6,12 and 24 ]
    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).


Secondary Outcome Measures :
  1. Lower Extremity Functional Scale (LEFS) [ Time Frame: Baseline and week 6, 12 and 24 ]
    The LEFS is a self-report measure of functional ability in relation to their Achilles tendinopathy, which will be completed by participants. The LEFS has been shown to have good construct validity and reliability. It is easy to administer and score so is applicable for research purposes and clinical decision making for individual patients (Binkley et al., 1999).

  2. Pain Detection Threshold, PDT using pressure algometry [ Time Frame: baseline and week 6, 12 and 24 ]
    The outcome measurement in pressure algometry is the pain detection threshold (PDT), measured in kg/f, or the point at which pressure pain is first experienced by the participant. As tenderness is one of the key clinical diagnostic criteria, algometry is an appropriate measure to quantify the pain pressure response.

  3. Ultra sound measure of Achilles thickness [ Time Frame: Baseline and week 6, 12 and 24 ]
    Ultra sound will be used to measure any change in transverse thickness (measure in mm) of the achilles over the course of the trial

  4. Numeric Rating Scale (NRS) for pain [ Time Frame: Baseline and week 6, 12 and 24 ]
    Participants will be asked to rate their Achilles pain from zero to ten on a numerical rating scale (NRS). Standardized and validated pain scales provide a means of measuring a patient's pain and of evaluating the response to treatment. Williamson and Hogart (2005) determined that NRS is valid, reliable and appropriate for use in clinical practice. Participants will be asked to verbally rate their level of perceived pain intensity on a numerical scale from 0 to 10, with zero representing "no pain" and 10 representing the "the worst pain possible"

  5. Star Excursion Balance Test (SEBT) [ Time Frame: baseline and week 6, 12 and 24 ]
    The modified Star Excursion Balance Test (SEBT) will be performed to assess whether any difference exists between the 2 groups and between the affected and unaffected limbs. The SEBT (appendix 3) has been shown to be a reliable measure of dynamic balance (Hertel et al, 2006).

  6. Heel raise for endurance [ Time Frame: Change in number of heel raises performed at baseline and week 6, 12 and 24 ]
    The heel raise test for endurance will be performed on one leg at a time with the participant standing. The participant will be allowed to have two fingers per hand, placed at shoulder height, against a wall for balance. Participants will be instructed to raise up as high as possible onto the toes and then lower the heel to the starting position and repeat this technique for as many as possible on each leg. The test will be terminated when the patient stops, or can no longer perform a heel raise. The number of heel raises and any pain associated with the test will be documented using the NRS.

  7. Heel raise for endurance [ Time Frame: Change in NRS with heel raises performed at baseline and week 6, 12 and 24 ]
    The heel raise test for endurance will be performed on one leg at a time with the participant standing. The participant will be allowed to have two fingers per hand, placed at shoulder height, against a wall for balance. Participants will be instructed to raise up as high as possible onto the toes and then lower the heel to the starting position and repeat this technique for as many as possible on each leg. The test will be terminated when the patient stops, or can no longer perform a heel raise. The number of heel raises and any pain associated with the test will be documented using the NRS.

  8. Hopping tests [ Time Frame: Change in number of hops performed at baseline and weeks 6, 12 and 24 ]
    Hopping tests involve the stretch shortening cycle of the Achilles tendon and calf musculature, and therefore measure the muscle tendon units elastic properties. Participants will be instructed to perform hopping on one leg at a time, with arms by the side, in a natural rhythm. A natural jump frequency is approximately 2 hops per second. Participants will be instructed to perform 20 hops on each leg with 15 to 30 seconds rest between each side. The number of hops performed and pain associated with hopping on each side will be documented using the NRS.Both the heel raise to endurance and hopping test have been shown to reliable tests with good test-retest reliability in previous studies of Achilles tendinopathy (Silbernagel et al, 2001 and 2006).

  9. Hopping tests [ Time Frame: Change in NRS associated with hopping performed at baseline and weeks 6, 12 and 24 ]
    Hopping tests involve the stretch shortening cycle of the Achilles tendon and calf musculature, and therefore measure the muscle tendon units elastic properties. Participants will be instructed to perform hopping on one leg at a time, with arms by the side, in a natural rhythm. A natural jump frequency is approximately 2 hops per second. Participants will be instructed to perform 20 hops on each leg with 15 to 30 seconds rest between each side. The number of hops performed and pain associated with hopping on each side will be documented using the NRS. Both the heel raise to endurance and hopping test have been shown to reliable tests with good test-retest reliability in previous studies of Achilles tendinopathy (Silbernagel et al, 2001 and 2006).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499484


Locations
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Ireland
Connolly Hospital, Blanchardstown
Dublin, Ireland, D15
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Research Board, Ireland
Investigators
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Study Director: Helen French, PhD Royal College of Surgeons, Ireland
Study Director: Trevor Duffy, MD, MBA Connolly Hospital, Dublin 15, Ireland

Publications:

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02499484     History of Changes
Other Study ID Numbers: RCSI-1764
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Nitroglycerin
Vasodilator Agents