Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks
研究概览
简要总结
Insertional Achilles tendinopathy is a disabling injury that is common in running athletes. Exercise therapy is considered the best treatment option, but there is still no agreement on the modalities. For example, it is thought that compression overload may be a major cause of tendinopathy and should therefore be restricted during rehabilitation. However, this recommendation is based on expert opinion and not on hard scientific evidence. Therefore, this randomised controlled trial (RCT) will investigate whether a therapy that limits the amount of compression of the tendon during a progressive tendon-loading rehabilitation protocol actually has better outcomes in athletes with insertional Achilles tendinopathy.
Athletes with insertional Achilles tendinopathy will be randomised into two treatment groups; (1) an experimental rehabilitation protocol in which the amount of tendon compression is limited and (2) a control rehabilitation protocol in which the amount of tendon compression is not limited and is rather high. Both treatments consist of supervised progressive tendon-loading exercise therapy and patient education. In addition, the experimental group will also receive heel inserts to limit the amount of dorsiflexion during sports or daily activities. At baseline, at 12 weeks (end of intervention) and at 24 weeks (follow-up), pain, functionality, structure and intratendinous pressure will be determined.
详细描述
Achilles tendinopathy is a debilitating injury that is common among athletes, especially those involved in running sports. Around 30% of all runners exhibit Achilles tendinopathy with an annual incidence of 7-9%. Of these patients, roughly one-third will have insertional Achilles tendinopathy (IAT). Several mechanisms are considered to play a role in the aetiology of Achilles tendinopathy, yet a prominent role seems present for excessive overload. Traditionally, the nature of this overload is thought to be purely tensile. However, the Achilles tendon can also be exposed to compressive loads at the insertion when the tendon wraps around the posterior prominence of the calcaneus during dorsiflexion of the ankle. The formation of fibrocartilage-like tissue, which is typically found in histological examination of tendinopathy, can be considered as an adaptation to this compressive load, driven by the tenocyte's mechanotransduction process. Therefore, it is recommended to reduce the amount of compressive load on the tendon during rehabilitation while exerting sufficient tensile load. However, these recommendations are mainly based on a pilot study and expert opinion. Therefore, this RCT investigates whether a therapy in which the amount of tendon compression is restricted during a progressive tendon-loading rehabilitation protocol actually has better outcomes in terms of pain scores, functionality and structure of the Achilles tendon in athletes with insertional Achilles tendinopathy. Limiting the amount of tendon compression on the Achilles tendon insertion will be achieved by (1) patient education, (2) heel inserts and (3) an adapted exercise regimen.
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 (Investigator, Outcomes Assessor)
盲法说明
The principal investigator (LP) will be blinded to the assigned treatment throughout the data collection period. During the study, patients will be asked not to discuss their treatment exercises with the principal investigator but to consult an independent second sports physician (AB) if they have any questions about the therapy.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old
- •Diagnosed with insertional Achilles Tendinopathy by a sports medicine physician
- •Have experienced symptoms for more than 3 months but less than 3 years
- •A severity level of less than 80 points on the VISA-A score
- •Playing running-based sports at least twice a week
- •Able to comply with both exercise programs
排除标准
- •Have a history of Achilles tendon rupture or surgery
- •Have other disorders of the Achilles tendon or ankle (mid-portional Achilles tendinopathy, paratenonitis, osteoarthritis,...)
- •Have rheumatological disorder (e.g. Spondylitis Ankylosis)
- •Have metabolic or endocrine disorders, such as type I or type II diabetes
- •Have had an Achilles injection in the past 3 months
- •Have other conditions that prevent following an active exercise programme
- •Have already been treated with physiotherapy, shockwave therapy or orthotics in the past 3 months
- •Medication use with (fluoro)quinolones antibiotic in the past 2 years
- •Currently pregnant
研究组 & 干预措施
Low Tendon Compression Rehabilitation (LTCR)
A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is limited (12 weeks).
干预措施: Exercise therapy (Other)
High Tendon Compression Rehabilitation (HTCR)
A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is not limited (12 weeks).
干预措施: Exercise therapy (usual care) (Other)
结局指标
主要结局
The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks
时间窗: 12 weeks (at the end of intervention)
The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.
The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 24 weeks
时间窗: 24 weeks (at follow-up)
The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.
次要结局
- Subjective patient satisfaction(This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).)
- Tampa scale for kinesiophobia (TSK)(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Health status using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Compliance(This will be assessed weekly until the end of the intervention.)
- Pain monitoring(This will be assessed weekly until the end of the intervention.)
- Ultrasound examination to assess the structure of the Achilles tendon insertion(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Credibility/Expectations Questionnaire(This wel be assessed at the start of the intervention (week 0))
- Return to sports rate(This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).)
- Adverse effects(This will be assessed weekly until the end of the intervention.)
- Pain rating (VAS) during activities of daily living(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Hop test(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Lower Extremity Functional Scale(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)
- Heel-raise test(This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).)