Achilles EntesopathyNCT04232358
Resistance Training and Injection Treatment for Achilles Enthesopathy
A study testing Corticosteroid injection and Local anesthesia injections in people with Achilles Entesopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies. The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading +… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Entesopathy
- What is being tested?
- Corticosteroid injection and Local anesthesia injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2021to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain from the achilles tendon insertion/heel for at least 3 months
- Achilles entesopathy verified by ultrasound
- Between 18 and 65 years of age
Who cannot join
- Prior surgery in the leg with the exception of knee arthroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles entesopathy within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
Read the detailed description
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
It is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
- Conditions
- Achilles Entesopathy
- Being tested
- Corticosteroid injection, Local anesthesia injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injectionDrug
Corticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.
Local anesthesia injectionsDrug
Local anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid injections + resistance training | Experimental | Corticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months Receives: Drug: Corticosteroid injection |
| Local anesthesia injections + resistance training | Placebo comparator | Local anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months Receives: Drug: Local anesthesia injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome
Measured: 6 months
Secondary outcomes (5)
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome
Measured: 3, 9 and 12 months
Evaluation of treatment effect measured on a Likert scale.
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study
Measured: 1, 2, 3, 6, 9 and 12 months
Ultrasonographic measurement of achilles tendon thickness
Ultrasonographic measurement of achilles tendon thickness in mm is measured relative to the baseline values
Measured: 1, 2, 3, 6, 9 and 12 months
Patient self reported activity level in percentage of the pre-injury activity level
Self reported activity in percentage of the pre-injury activity level
Measured: 3, 6 and 12 months
Ultrasonographic measurement of achilles tendon doppler activity
Ultrasonographic measurement of achilles tendon doppler activity is measured (grade I-III) relative to the baseline values
Measured: 1, 2, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 May 2021
- 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.
- Other trials for Achilles EntesopathyStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Doessing, M.D., PhD, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232358
- Sponsor's protocol ID
- H-19041374
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy
- ClinicalTrials.gov ID
- NCT04232358
- Acronym / sponsor ID
- H-19041374
- Conditions
- Achilles Entesopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Jan 2020 (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.
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
Detailed description
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
It is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid injections + resistance training | Experimental | Drug: Corticosteroid injectionCorticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months |
| Local anesthesia injections + resistance training | Placebo comparator | Drug: Local anesthesia injectionsLocal anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain from the achilles tendon insertion/heel for at least 3 months
- Achilles entesopathy verified by ultrasound
- Between 18 and 65 years of age
Key exclusion criteria (4 listed)
- Prior surgery in the leg with the exception of knee arthroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles entesopathy within the last 6 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 |
|---|---|---|
| Corticosteroid injectionCorticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections. | Drug | Corticosteroid injections + resistance training |
| Local anesthesia injectionsLocal anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections. | Drug | Local anesthesia injections + resistance training |
Primary outcome
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
Time frame: 6 months
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome
5 secondary outcomes
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
Time frame: 3, 9 and 12 months
Evaluation of treatment effect measured on a Likert scale.
Time frame: 1, 2, 3, 6, 9 and 12 months
Ultrasonographic measurement of achilles tendon thickness
Time frame: 1, 2, 3, 6, 9 and 12 months
Patient self reported activity level in percentage of the pre-injury activity level
Time frame: 3, 6 and 12 months
Ultrasonographic measurement of achilles tendon doppler activity
Time frame: 1, 2, 3, 6, 9 and 12 months
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid injection and Local anesthesia injections in people with Achilles Entesopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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 3 inclusion and 4 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 2 Nov 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.