TendinopathyPhase 4HATNCT02996409
High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy
A Phase 4 study testing HVIGI, LVIGI and Progressive exercise program in people with Tendinopathy and Achilles Tendon Pain, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendinopathy, Achilles Tendon Pain, Injection Site Fibrosis
- What is being tested?
- HVIGI, LVIGI and Progressive exercise program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2016to Jul 2019
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years.
- Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion.
- Non-response to exercise program for 6 weeks.
- Painful Achilles tendon for more than 2 months.
- Neovascularisation is present on Power Doppler Ultrasonography examination
Who cannot join
- Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
- Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
- Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
- Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot in combination with localized pain)
- Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
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- Condition that prevents the patients from executing an active exercise program
- Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids).
- Previous Achilles tendon rupture.
- Patient has received surgical intervention for his injury.
- Patient does not wish, for whatever reason, to undergo one of the two treatments
- A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication)
- Known presence of a pregnancy
- Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins
- Inability to give informed consent.
- Participation in other concomitant treatment programs.
- Patient has already one side included in this study.
- Allergy for lidocain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.
Read the detailed description
Background of the study - Overuse injury of the Achilles tendon is a common entity in athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this gives great results, however there is a significant group of patients in which the exercise program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies used a comparative group. There is consequently a lack of high-quality studies in this field and therefore the investigators cannot recommend this treatment yet for this indication.
Objective of the study - To investigate the efficacy of a high-volume image guided injection (HVIGI) in chronic midportion Achilles tendinopathy.
Hypothesis - The average VISA-A score is higher in the patient group treated with a progressive exercise program in combination with a high volume image guided injection in comparison with the group treated with low volume injection as a control group in combination with a progressive exercise program.
Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization and stratification (based on activity level using the Ankle Activity Score) will be performed using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24 weeks post injection. At every time point both the primary and secondary outcome measurements will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be derived at baseline and 24 week post injection.
Study population - In total, 80 patients with clinically diagnosed chronic midportion Achilles tendinopathy will be included in this study.
- Conditions
- Tendinopathy, Achilles Tendon Pain, Injection Site Fibrosis
- Being tested
- HVIGI, LVIGI, Progressive exercise program
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVIGIDrug
Also called Saline 0.9% 40 ml, Lidocain 1.0% 10 ml
High Volume Image-Guided Injection with a saline/lidocain solution
LVIGIDrug
Also called Saline 0.9% 1.6 ml, Lidocain 1.0% 0.4 ml
Placebo control with injection of a saline/lidocain solution (low volume)
Progressive exercise programOther
A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.
| Study group | Role | What they receive |
|---|---|---|
| High-Volume Image-Guided Injection | Experimental | HVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. Receives: Drug: HVIGI; Other: Progressive exercise program |
| Low-Volume Image-Guided Injection | Placebo comparator | LVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. Receives: Drug: LVIGI; Other: Progressive exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)
Measured: Change in VISA-A score at 24 weeks
Secondary outcomes (12)
Pain detect questionnaire (PD-Q)
Measured: Change in pain detect score at 24 weeks
The Pain Coping Inventory (PCI)
Measured: Change in PCI score at 24 weeks
10 hop test
Measured: Change in visual analogue scale score following a 10 hop test at 24 weeks
Flexibility m. gastrocnemius using a goniometer
Measured: Change in flexibility of the gastrocnemius muscle at 24 weeks
Flexibility m. soleus using a goniometer
Measured: Change in flexibility of the soleus muscle at 24 weeks
Power m. gastrocnemius using a hand-held dynamometer
Measured: Change in power of the gastrocnemius muscle at 24 weeks
Power m. soleus using a hand-held dynamometer
Measured: Change in power of the soleus muscle at 24 weeks
Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination)
Ultrasonography examination before and after eccentric/isotonic calf exercises or rest
Measured: Change in degree of neovascularization at 24 weeks
Return to sports using a standardized weekly questionnaire
Measured: Change in return to sport at 24 weeks
Compliance to the exercise program and return to sports activity program using a standardized weekly questionnaire assessing the percentage of exercises that is performed
Measured: Change in compliance at 24 weeks
Patient satisfaction with treatment results
Measured: Change at 24 weeks
Patient Acceptable Symptom Scale (PASS)
Measured: Change at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Arthritis Association, The Anna Foundation
- Responsible party
- Principal investigator, A.C. van der Vlist, Erasmus Medical Center
- Investigators
- R.J. de Vos, PhD, Principal investigator, Erasmus MC University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996409
- Sponsor's protocol ID
- 51623
- Acronym
- HAT
- Status last verified
- Aug 2019
- First submitted
- 20 Oct 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
van Oosten CCM, van der Vlist AC, van Veldhoven PLJ, van Oosterom RF, Verhaar JAN, de Vos RJ. Do High-Volume Injections Affect the Ultrasonographic Neovascularization in Chronic Achilles Tendinopathy? A Randomized Placebo-Controlled Clinical Trial. Clin J Sport Med. 2022 Sep 1;32(5):451-457. doi: 10.1097/JSM.0000000000000998. Epub 2021 Dec 9.
PubMed 36083324Sleeswijk Visser TSO, van der Vlist AC, van Oosterom RF, van Veldhoven P, Verhaar JAN, de Vos RJ. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ Open Sport Exerc Med. 2021 Mar 26;7(1):e001023. doi: 10.1136/bmjsem-2020-001023. eCollection 2021.
PubMed 33868707van der Vlist AC, van Oosterom RF, van Veldhoven PLJ, Bierma-Zeinstra SMA, Waarsing JH, Verhaar JAN, de Vos RJ. Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial. BMJ. 2020 Sep 9;370:m3027. doi: 10.1136/bmj.m3027.
PubMed 33315586
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02996409
- Acronym / sponsor ID
- HAT / 51623
- Conditions
- Tendinopathy, Achilles Tendon Pain, Injection Site Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Arthritis Association, The Anna Foundation
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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.
Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.
Detailed description
Background of the study - Overuse injury of the Achilles tendon is a common entity in athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this gives great results, however there is a significant group of patients in which the exercise program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies used a comparative group. There is consequently a lack of high-quality studies in this field and therefore the investigators cannot recommend this treatment yet for this indication.
Objective of the study - To investigate the efficacy of a high-volume image guided injection (HVIGI) in chronic midportion Achilles tendinopathy.
Hypothesis - The average VISA-A score is higher in the patient group treated with a progressive exercise program in combination with a high volume image guided injection in comparison with the group treated with low volume injection as a control group in combination with a progressive exercise program.
Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization and stratification (based on activity level using the Ankle Activity Score) will be performed using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24 weeks post injection. At every time point both the primary and secondary outcome measurements will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be derived at baseline and 24 week post injection.
Study population - In total, 80 patients with clinically diagnosed chronic midportion Achilles tendinopathy will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Volume Image-Guided Injection | Experimental | Drug: HVIGI, Other: Progressive exercise programHVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. |
| Low-Volume Image-Guided Injection | Placebo comparator | Drug: LVIGI, Other: Progressive exercise programLVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years.
- Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion.
- Non-response to exercise program for 6 weeks.
- Painful Achilles tendon for more than 2 months.
- Neovascularisation is present on Power Doppler Ultrasonography examination
Key exclusion criteria (18 listed)
- Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
- Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
- Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
- Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot in combination with localized pain)
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 |
|---|---|---|
| HVIGIAlso: Saline 0.9% 40 ml, Lidocain 1.0% 10 mlHigh Volume Image-Guided Injection with a saline/lidocain solution | Drug | High-Volume Image-Guided Injection |
| LVIGIAlso: Saline 0.9% 1.6 ml, Lidocain 1.0% 0.4 mlPlacebo control with injection of a saline/lidocain solution (low volume) | Drug | Low-Volume Image-Guided Injection |
| Progressive exercise programA 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises. | Other | High-Volume Image-Guided Injection, Low-Volume Image-Guided Injection |
Primary outcome
Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)
Time frame: Change in VISA-A score at 24 weeks
12 secondary outcomes
Pain detect questionnaire (PD-Q)
Time frame: Change in pain detect score at 24 weeks
The Pain Coping Inventory (PCI)
Time frame: Change in PCI score at 24 weeks
10 hop test
Time frame: Change in visual analogue scale score following a 10 hop test at 24 weeks
Flexibility m. gastrocnemius using a goniometer
Time frame: Change in flexibility of the gastrocnemius muscle at 24 weeks
Flexibility m. soleus using a goniometer
Time frame: Change in flexibility of the soleus muscle at 24 weeks
Power m. gastrocnemius using a hand-held dynamometer
Time frame: Change in power of the gastrocnemius muscle at 24 weeks
Power m. soleus using a hand-held dynamometer
Time frame: Change in power of the soleus muscle at 24 weeks
Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination)
Time frame: Change in degree of neovascularization at 24 weeks
Return to sports using a standardized weekly questionnaire
Time frame: Change in return to sport at 24 weeks
Compliance to the exercise program and return to sports activity program using a standardized weekly questionnaire assessing the percentage of exercises that is performed
Time frame: Change in compliance at 24 weeks
Patient satisfaction with treatment results
Time frame: Change at 24 weeks
Patient Acceptable Symptom Scale (PASS)
Time frame: Change at 24 weeks
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 15 Aug 2019.
- Derived from this study: PubMed 36083324van Oosten CCM, van der Vlist AC, van Veldhoven PLJ, van Oosterom RF, Verhaar JAN, de Vos RJ. Do High-Volume Injections Affect the Ultrasonographic Neovascularization in Chronic Achilles Tendinopathy? A Randomized Placebo-Controlled Clinical Trial. Clin J Sport Med. 2022 Sep 1;32(5):451-457. doi: 10.1097/JSM.0000000000000998. Epub 2021 Dec 9.
- Derived from this study: PubMed 33868707Sleeswijk Visser TSO, van der Vlist AC, van Oosterom RF, van Veldhoven P, Verhaar JAN, de Vos RJ. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ Open Sport Exerc Med. 2021 Mar 26;7(1):e001023. doi: 10.1136/bmjsem-2020-001023. eCollection 2021.
- Derived from this study: PubMed 33315586van der Vlist AC, van Oosterom RF, van Veldhoven PLJ, Bierma-Zeinstra SMA, Waarsing JH, Verhaar JAN, de Vos RJ. Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial. BMJ. 2020 Sep 9;370:m3027. doi: 10.1136/bmj.m3027.
- Individual participant dataSharing planned: Undecided
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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.
R.J. de Vos, PhD principal investigator
Erasmus MC University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HVIGI, LVIGI and Progressive exercise program in people with Tendinopathy and Achilles Tendon Pain, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 18 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 15 Aug 2019. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) (time frame: Change in VISA-A score at 24 weeks). 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 NCT02996409, which also lists 3 linked publications.
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 15 Aug 2019.