Insertional Achilles TendinopathyGhenTendonNCT05456620
Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy
A study testing Exercise therapy in people with Insertional Achilles Tendinopathy, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy: a Randomised Clinical Trial
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.
Read the 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.
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- Exercise therapy, Exercise therapy (usual care)
- Keywords
- Exercise therapy, Tendon compression, Tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
The intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes:
- Education: Specific information on the importance of limiting tendon compression during rehabilitation, as well as general information on load management, the importance of active exercise therapy and setting expectations.
- Orthotic treatment: heel inserts to reduce ankle dorsiflexion during daily activities and sports
- Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) restricting the amount of tendon compression by limiting dorsiflexion of the ankle and prohibiting stretching
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:
- Education: general information on load management, the importance of active exercise therapy and setting expectations.
- No orthotic treatment.
- Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) without any restriction around tendon compression and encouraging stretching
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Exercise therapy |
| 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). Receives: Other: Exercise therapy (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks (at follow-up)
Secondary outcomes (13)
Subjective patient satisfaction
Patient overall rating: excellent / good / fair / poor
Measured: This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).
Return to sports rate
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: This will be assessed weekly until the end of the intervention.
Adverse effects
Adverse effects resulting from the intervention
Measured: 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.
Measured: This wel be assessed at the start of the intervention (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start5 Dec 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Vanden Bossche, Principal investigator, Department of Rehabilitation Sciences, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456620
- Sponsor's protocol ID
- BC-11818
- Acronym
- GhenTendon
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40011018
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05456620
- Acronym / sponsor ID
- GhenTendon / BC-11818
- Conditions
- Insertional Achilles Tendinopathy
- Keywords
- Exercise therapy, Tendon compression, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Tendon Compression Rehabilitation (LTCR) | Experimental | Other: Exercise therapyA 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 | Other: Exercise therapy (usual care)A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is not limited (12 weeks). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapyThe intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes: 1. Education: Specific information on the importance of limiting tendon compression during rehabilitation, as well as general information on load management, the importance of active exercise therapy and setting expectations. 2. Orthotic treatment: heel inserts to reduce ankle dorsiflexion during daily activities and sports 3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) restricting the amount of tendon compression by limiting dorsiflexion of the ankle and prohibiting stretching | Other | Low Tendon Compression Rehabilitation (LTCR) |
| Exercise therapy (usual care)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: 1. Education: general information on load management, the importance of active exercise therapy and setting expectations. 2. No orthotic treatment. 3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) without any restriction around tendon compression and encouraging stretching | Other | High Tendon Compression Rehabilitation (HTCR) |
Primary outcome
The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks
Time frame: 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
Time frame: 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.
13 secondary outcomes
Subjective patient satisfaction
Time frame: This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).
Return to sports rate
Time frame: This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).
Hop test
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Compliance
Time frame: This will be assessed weekly until the end of the intervention.
Pain monitoring
Time frame: This will be assessed weekly until the end of the intervention.
Adverse effects
Time frame: This will be assessed weekly until the end of the intervention.
Credibility/Expectations Questionnaire
Time frame: This wel be assessed at the start of the intervention (week 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 40011018Pringels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Vanden Bossche principal investigator
Department of Rehabilitation Sciences, Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Insertional Achilles Tendinopathy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks (time frame: 12 weeks (at the end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.