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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Tendon Compression Rehabilitation (LTCR) | Experimental | A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is limited (12 weeks). |
|
| High Tendon Compression Rehabilitation (HTCR) | Active Comparator | A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is not limited (12 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy | Other | The intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks | 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. | 12 weeks (at the end of intervention) |
| The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 24 weeks | 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. | 24 weeks (at follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective patient satisfaction | Patient overall rating: excellent / good / fair / poor | This will be assessed at the end of the intervention (week 12) and at follow-up (week 24). |
| Return to sports rate |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound examination to assess presence of rectrocalcaneal bursitis and/or intratendinous calcifications | Ultrasound examination of the Achilles tendon to assess associated presence of rectrocalcaneal bursitis and/or intratendinous calcifications at the Achilles tendon insertion | This will be assessed at baseline (week 0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Vanden Bossche | Department of Rehabilitation Sciences, Ghent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of rehabilitation sciences | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011018 | Derived | Pringels L, Capelleman R, Van den Abeele A, Burssens A, Planckaert G, Wezenbeek E, Vanden Bossche L. Effectiveness of reducing tendon compression in the rehabilitation of insertional Achilles tendinopathy: a randomised clinical trial. Br J Sports Med. 2025 Apr 24;59(9):640-650. doi: 10.1136/bjsports-2024-109138. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2025 | |
| Reset | May 5, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2023 | Jul 2, 2024 | SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2025 | May 5, 2025 |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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.
|
| Exercise therapy (usual care) | Other | The control treatment consists of a progressive 4-phase, criteria-based exercise protocol, in which the amount of tendon compression is not limited. This includes:
|
|
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
| This will be assessed at the end of the intervention (week 12) and at follow-up (week 24). |
| Hop test | Self-reported pain rating on a Visual Analogue Scale (VAS) during a single leg 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 | The lower extremity functional scale (LEFS) is a valid patient-rated outcome measure for the measurement of lower extremity function. | This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24). |
| Tampa scale for kinesiophobia (TSK) | 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. | 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 | Participants will have to perform heel raises in standing position until thay are fatigued. | 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 | The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. | This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24). |
| Pain rating (VAS) during activities of daily living | Self-reported pain (VAS, 0-100 mm) during activities of daily living over the last seven days. A higher score indicates more pain. | This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24). |
| Ultrasound examination to assess the structure of the Achilles tendon insertion | Anteroposterior thickness (5 mm distal from the posterosuperior calcaneal border) - Neovascularisation (modified-Öhberg scale) | This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24). |
| Compliance | Compliance to the exercise programme and orthotics (total percentage of prescription) will be assessed using a short online questionnaire. | This will be assessed weekly until the end of the intervention. |
| Pain monitoring | Numeric Pain Rating Scale (NRS, 0-10) during exercises, after exercises and in the morning will be assessed. A higher score indicates more pain. | This will be assessed weekly until the end of the intervention. |
| Adverse effects | Adverse effects resulting from the intervention | This will be assessed weekly until the end of the intervention. |
| Credibility/Expectations Questionnaire | 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. | This wel be assessed at the start of the intervention (week 0) |
| X-ray to assess presence of Haglund's deformity |
X-ray of the ankle to assess associated presence of Haglund's deformity |
| This will be assessed at baseline (week 0) |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |