Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy
- Conditions
- Insertional Achilles Tendinopathy
- Interventions
- Other: Exercise therapy (usual care)Other: Exercise therapy
- Registration Number
- NCT05456620
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Tendon Compression Rehabilitation (HTCR) Exercise therapy (usual care) A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is not limited (12 weeks). Low Tendon Compression Rehabilitation (LTCR) Exercise therapy A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is limited (12 weeks).
- Primary Outcome Measures
Name Time Method The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks 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 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.
- Secondary Outcome Measures
Name Time Method Subjective patient satisfaction This will be assessed at the end of the intervention (week 12) and at follow-up (week 24). Patient overall rating: excellent / good / fair / poor
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). The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
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). The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire.
Compliance This will be assessed weekly until the end of the intervention. Compliance to the exercise programme and orthotics (total percentage of prescription) will be assessed using a short online questionnaire.
Pain monitoring This will be assessed weekly until the end of the intervention. Numeric Pain Rating Scale (NRS, 0-10) during exercises, after exercises and in the morning will be assessed. A higher score indicates more pain.
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). Anteroposterior thickness (5 mm distal from the posterosuperior calcaneal border) - Neovascularisation (modified-Öhberg scale)
Credibility/Expectations Questionnaire This wel be assessed at the start of the intervention (week 0) As participants are not blinded about their assigned intervention, it is important to determine their beliefs about the treatment. With this in mind, participants will complete the Credibility/Expectations Questionnaire (CEQ) after being assigned to an intervention group.
Return to sports rate This will be assessed at the end of the intervention (week 12) and at follow-up (week 24). Participation: return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports
Adverse effects This will be assessed weekly until the end of the intervention. Adverse effects resulting from 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). Self-reported pain (VAS, 0-100 mm) during activities of daily living over the last seven days. A higher score indicates more pain.
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). Self-reported pain rating on a Visual Analogue Scale (VAS) during a single leg hop test
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). The lower extremity functional scale (LEFS) is a valid patient-rated outcome measure for the measurement of lower extremity function.
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). Participants will have to perform heel raises in standing position until thay are fatigued.
Trial Locations
- Locations (1)
Department of rehabilitation sciences
🇧🇪Ghent, Belgium