The Use of Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy: a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- VISA A, Victoria Institute of Sport Assessment - Achilles
研究概览
简要总结
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.
详细描述
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 randomly allocated to one of 2 groups. Group 1 will receive GTN for 24 weeks in combination with a supervised eccentric exercise programme delivered over 12 weeks. Group 2 will receive placebo GTN in addition to the same exercise programme.
Ethical Considerations Ethics approval will be sought from Connolly Hospital Research and Ethics Committee. All participants will give written informed consent.
At the patient's initial assessment, the following will be completed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
- •Any medical or psychiatric condition that the investigator deems appropriate for exclusion
- •Staff or students of Connolly Hospital, Blanchardstown
研究组 & 干预措施
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
干预措施: glyceryl trinitrate (Drug)
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
干预措施: Eccentric exercise program (Other)
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
干预措施: Placebo ointment (Other)
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
干预措施: Eccentric exercise program (Other)
结局指标
主要结局
VISA A, Victoria Institute of Sport Assessment - Achilles
时间窗: 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).
次要结局
- 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)
- Heel raise for endurance(Change in NRS with heel raises performed at baseline and week 6, 12 and 24)
- Hopping tests(Change in NRS associated with hopping performed at baseline and weeks 6, 12 and 24)