TendinopathyNCT02839577
The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy
A study testing High Volume injection without corticosteroid and High Volume injection with corticosteroid in people with Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT). Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- High Volume injection without corticosteroid and High Volume injection with corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Dec 2014
- 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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically and ultrasound diagnosed unilateral mid-tendinous Achilles tendinopathy.
- Symptoms > 3 month
Who cannot join
- Bilateral achilles tendinopathy
- Insertional tendinopathy
- Steroid injections < 12 month
- Diabetes or cardiovascular disease
- Smoking
- Treatment with fluoroquinolones < 6 month
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sportsmedicine, Bispebjerg hospital
Copenhagen, 2400
About this study
Official title: The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy: A Randomized Double Blinded Prospective Trial
The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).
Read more
All subjects will perform a 12-wk eccentric training program with further eccentric training 3 times per week from week 12 to week 24.
Clinical examinations and ultrasound will be performed at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between the two groups.
Read the detailed description
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. High Volume Injection therapy (HVI) seems to show promising results in Achilles tendinopathy (AT). HVI consist of a large volume of saline with a small amount of steroid. Steroid injections is widely used for treating tendinopathy but we know from the literature that steroid injections only gives a fast and short term pain reduction in tendinopathy where HVI seems to show both a short term and a more prolonged effect which could contribute the volume effect (saline).
Aim: The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 mls saline) The injections will be performed under ultrasound guidance. All subjects will undergo a 12 week eccentric training program and the subjects will continue eccentric training 3 times per week from week 12 to week 24.
Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and color Doppler. All outcome measures will be recorded at baseline and again at 6 weeks, 12 weeks and 24 weeks follow-up.
Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.
- Conditions
- Tendinopathy
- Being tested
- High Volume injection without corticosteroid, High Volume injection with corticosteroid
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Volume injection without corticosteroidDrug
Also called HVI without corticosteroid
Injection with 10 mls 0.5% bupivacaine hydrochloride and
- 40 ml saline around the tendon.
High Volume injection with corticosteroidDrug
Also called HVI with corticosteroid
Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.
| Study group | Role | What they receive |
|---|---|---|
| High Volume injection (HVI) with corticosteroid | Active comparator | * 10 mls 0.5% bupivacaine hydrochloride
* 20 mg of Depomedrol (40 mg/ml methylprednisolonacetat)
* 40 mls saline (NaCl)
HVI with corticosteroid is injected one time at baseline and compared to HVI without corticosteroid. Receives: Drug: High Volume injection without corticosteroid |
| High Volume injection (HVI) without corticosteroid | Active comparator | * 10 mls 0.5% bupivacaine hydrochloride
* 40 mls saline (NaCl)
HVI with corticosteroid is injected one time at baseline and compared to HVI with corticosteroid. Receives: Drug: High Volume injection with corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)
Changes in VISA-A score over time between the two groups
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes (2)
The Visual analogue pain scale (VAS score)
Changes in VAS score over time between the two groups
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks
Ultrasound tendon thickness and color Doppler
Changes in tendon thickness and color Doppler between the two groups
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ploug Boesen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839577
- Sponsor's protocol ID
- H-1-2010-052b
- Status last verified
- Jun 2017
- First submitted
- 8 Jul 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy: A Randomized Double Blinded Prospective Trial
- ClinicalTrials.gov ID
- NCT02839577
- Acronym / sponsor ID
- H-1-2010-052b
- Conditions
- Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jul 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.
The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).
All subjects will perform a 12-wk eccentric training program with further eccentric training 3 times per week from week 12 to week 24.
Clinical examinations and ultrasound will be performed at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between the two groups.
Detailed description
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. High Volume Injection therapy (HVI) seems to show promising results in Achilles tendinopathy (AT). HVI consist of a large volume of saline with a small amount of steroid. Steroid injections is widely used for treating tendinopathy but we know from the literature that steroid injections only gives a fast and short term pain reduction in tendinopathy where HVI seems to show both a short term and a more prolonged effect which could contribute the volume effect (saline).
Aim: The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 mls saline) The injections will be performed under ultrasound guidance. All subjects will undergo a 12 week eccentric training program and the subjects will continue eccentric training 3 times per week from week 12 to week 24.
Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and color Doppler. All outcome measures will be recorded at baseline and again at 6 weeks, 12 weeks and 24 weeks follow-up.
Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Volume injection (HVI) with corticosteroid | Active comparator | Drug: High Volume injection without corticosteroid* 10 mls 0.5% bupivacaine hydrochloride * 20 mg of Depomedrol (40 mg/ml methylprednisolonacetat) * 40 mls saline (NaCl) HVI with corticosteroid is injected one time at baseline and compared to HVI without corticosteroid. |
| High Volume injection (HVI) without corticosteroid | Active comparator | Drug: High Volume injection with corticosteroid* 10 mls 0.5% bupivacaine hydrochloride * 40 mls saline (NaCl) HVI with corticosteroid is injected one time at baseline and compared to HVI with corticosteroid. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically and ultrasound diagnosed unilateral mid-tendinous Achilles tendinopathy.
- Symptoms > 3 month
Key exclusion criteria (6 listed)
- Bilateral achilles tendinopathy
- Insertional tendinopathy
- Steroid injections < 12 month
- Diabetes or cardiovascular disease
- Smoking
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 |
|---|---|---|
| High Volume injection without corticosteroidAlso: HVI without corticosteroidInjection with 10 mls 0.5% bupivacaine hydrochloride and • 40 ml saline around the tendon. | Drug | High Volume injection (HVI) with corticosteroid |
| High Volume injection with corticosteroidAlso: HVI with corticosteroidInjection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon. | Drug | High Volume injection (HVI) without corticosteroid |
Primary outcome
The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
Changes in VISA-A score over time between the two groups
2 secondary outcomes
The Visual analogue pain scale (VAS score)
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
Ultrasound tendon thickness and color Doppler
Time frame: Baseline, 6 weeks, 12 weeks and 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 2 Jul 2017.
- 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.
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 High Volume injection without corticosteroid and High Volume injection with corticosteroid in people with Tendinopathy, 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 2 inclusion and 6 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 Jul 2017. 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. 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 Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score) (time frame: Baseline, 6 weeks, 12 weeks and 24 weeks). 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 Jul 2017.