TendinopathyNCT02417987
High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy
A study testing High Volume injection and Autologous conditioned plasma (ACP) in people with Tendinopathy, run by Bispebjerg Hospital.
Trial summary
The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- High Volume injection and Autologous conditioned plasma (ACP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Nov 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically and ultrasound diagnosed unilateral midt-tendinous achilles tendinopathy
- Symptoms > 3 month
- No steroid injections < 6 month
- 60 males with BMI <30 between 18-60 years.
Who cannot join
- Bilateral achilles tendinopathy
- Insertional tendinopathy
- Steroid injections < 6 month
- Diabetes or cardiovascular disease
- Smoking
- Treatment with fluoroquinolones < 6 month
About this study
Official title: High Volume Injection (HVI) or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy: A Randomized Controlled Double Blinded Trial
The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises).
Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4 mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training program and examinations will be done 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 groups (HVI, ACP and Plc)
Read the detailed description
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. Only sparse scientific evidence exists for the present used treatments and no golden standard treatment exists so far.
Aim: The aim of the study is in AT patients to examine and compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment and eccentric exercises).
Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4 mls) or 3) placebo (Plc) treatment. Participants will treated on 4 successive occasions with 2 weeks (wks) interval (HVI will only be injected once at baseline, the 3 following injections will be placebo). The injections will be performed under ultrasound guidance. All subjects will undergo a 12-wk eccentric training program. Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and muscle function (one-legged heel-rise test). All outcome measures will be recorded at baseline and again at 6 weeks, 12 week and 6 month follow-up.
Results: Will se the changes and differences between groups (HVI, ACP and Placebo) in VISA-A scores, VAS scores, ultrasound (tendon thickness) and muscle function.
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
- Placebo, High Volume injection, Autologous conditioned plasma (ACP)
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Sham treatment
The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon
High Volume injectionDrug
Also called HVI
Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon
Autologous conditioned plasma (ACP)Biological
Also called Platelet-rich plasma (PRP)
Injection with 4 mls of ACP around the tendon
| Study group | Role | What they receive |
|---|---|---|
| High Volume injection | Active comparator | A total volume of 50 ml:
* 10 mls 0.5% bupivacaine hydrochloride and
* 20 mg of Depomedrol (hydrocortisone)
* 40 mls saline (NaCl) HVI is injected one time at baseline and thereafter the group received sham treatment at 2 weeks, 4 weeks and after 6 weeks. Receives: Other: Placebo; Biological: Autologous conditioned plasma (ACP) |
| Autologous conditioned plasma (ACP) | Active comparator | Whole blood was drawn from the patients using arthrex system (total of 10 mls whole blood). After that the whole blood is spined for 5 minutes and ACP with platelets and growth factors is separated from the red and white blood cells (4 mls).
The ACP is injected 4 times (at baseline, 2 weeks, 4 weeks and after 6 weeks) Receives: Other: Placebo; Drug: High Volume injection |
| Placebo | Sham comparator | A few drops of saline is injected in the soft tissue away from the tendon. Receives: Drug: High Volume injection; Biological: Autologous conditioned plasma (ACP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A score
See the changes in VISA-A score over time due to the effect of treatment between groups (HVI, ACP and Plc)
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes (2)
VAS score
See the changes in VAS score over time due to the effect of treatment between groups (HVI, ACP and Plc)
Measured: Baseline, 6 weeks, 12 weeks and 24 weeks
Ultrasound tendon thickness and doppler activity
See the changes in tendon thickness over time due to the effect of treatment between groups (HVI, ACP and Plc)
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 posted16 Apr 2015 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionNov 2014
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 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ploug Boesen, Bispebjerg Hospital
- Investigators
- Michael Kjaer, Dr. Med., Principal investigator, Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417987
- Sponsor's protocol ID
- H-1-2010-052a
- Status last verified
- Apr 2015
- First submitted
- 4 Nov 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boesen AP, Hansen R, Boesen MI, Malliaras P, Langberg H. Effect of High-Volume Injection, Platelet-Rich Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study. Am J Sports Med. 2017 Jul;45(9):2034-2043. doi: 10.1177/0363546517702862. Epub 2017 May 22.
PubMed 28530451
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Injection (HVI) or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy: A Randomized Controlled Double Blinded Trial
- ClinicalTrials.gov ID
- NCT02417987
- Acronym / sponsor ID
- H-1-2010-052a
- Conditions
- Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Apr 2015 (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 examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises).
Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4 mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training program and examinations will be done 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 groups (HVI, ACP and Plc)
Detailed description
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. Only sparse scientific evidence exists for the present used treatments and no golden standard treatment exists so far.
Aim: The aim of the study is in AT patients to examine and compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment and eccentric exercises).
Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4 mls) or 3) placebo (Plc) treatment. Participants will treated on 4 successive occasions with 2 weeks (wks) interval (HVI will only be injected once at baseline, the 3 following injections will be placebo). The injections will be performed under ultrasound guidance. All subjects will undergo a 12-wk eccentric training program. Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and muscle function (one-legged heel-rise test). All outcome measures will be recorded at baseline and again at 6 weeks, 12 week and 6 month follow-up.
Results: Will se the changes and differences between groups (HVI, ACP and Placebo) in VISA-A scores, VAS scores, ultrasound (tendon thickness) and muscle function.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| High Volume injection | Active comparator | Other: Placebo, Biological: Autologous conditioned plasma (ACP)A total volume of 50 ml: * 10 mls 0.5% bupivacaine hydrochloride and * 20 mg of Depomedrol (hydrocortisone) * 40 mls saline (NaCl) HVI is injected one time at baseline and thereafter the group received sham treatment at 2 weeks, 4 weeks and after 6 weeks. |
| Autologous conditioned plasma (ACP) | Active comparator | Other: Placebo, Drug: High Volume injectionWhole blood was drawn from the patients using arthrex system (total of 10 mls whole blood). After that the whole blood is spined for 5 minutes and ACP with platelets and growth factors is separated from the red and white blood cells (4 mls). The ACP is injected 4 times (at baseline, 2 weeks, 4 weeks and after 6 weeks) |
| Placebo | Sham comparator | Drug: High Volume injection, Biological: Autologous conditioned plasma (ACP)A few drops of saline is injected in the soft tissue away from the tendon. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinically and ultrasound diagnosed unilateral midt-tendinous achilles tendinopathy
- Symptoms > 3 month
- No steroid injections < 6 month
- 60 males with BMI <30 between 18-60 years.
Key exclusion criteria (6 listed)
- Bilateral achilles tendinopathy
- Insertional tendinopathy
- Steroid injections < 6 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 |
|---|---|---|
| PlaceboAlso: Sham treatmentThe skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon | Other | Autologous conditioned plasma (ACP), High Volume injection |
| High Volume injectionAlso: HVIInjection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon | Drug | Autologous conditioned plasma (ACP), Placebo |
| Autologous conditioned plasma (ACP)Also: Platelet-rich plasma (PRP)Injection with 4 mls of ACP around the tendon | Biological | High Volume injection, Placebo |
Primary outcome
VISA-A score
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
See the changes in VISA-A score over time due to the effect of treatment between groups (HVI, ACP and Plc)
2 secondary outcomes
VAS score
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
Ultrasound tendon thickness and doppler activity
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 21 Apr 2015.
- Derived from this study: PubMed 28530451Boesen AP, Hansen R, Boesen MI, Malliaras P, Langberg H. Effect of High-Volume Injection, Platelet-Rich Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study. Am J Sports Med. 2017 Jul;45(9):2034-2043. doi: 10.1177/0363546517702862. Epub 2017 May 22.
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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.
Michael Kjaer, Dr. Med. principal investigator
Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
A study testing High Volume injection and Autologous conditioned plasma (ACP) in people with Tendinopathy, run by Bispebjerg Hospital.
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 4 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
On the ClinicalTrials.gov record for NCT02417987, 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 21 Apr 2015.