Chronic Achilles TendinopathyPhase 4NCT00377910
The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy
A Phase 4 study testing Aethoxysclerol in people with Chronic Achilles Tendinopathy, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Achilles Tendinopathy
- What is being tested?
- Aethoxysclerol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive
Who cannot join
- Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
Read the detailed description
48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.
- Conditions
- Chronic Achilles Tendinopathy
- Being tested
- Aethoxysclerol
- Keywords
- Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AethoxysclerolDrug
Also called 1. drug: Polidocanol, 2. drug: Lidocaine
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
| Study group | Role | What they receive |
|---|---|---|
| 1, drug | Active comparator | Injections of polidocanol Receives: Drug: Aethoxysclerol |
| 2 drug | Placebo comparator | injections of lidocaine Receives: Drug: Aethoxysclerol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during physical activity which usually causes pain
Measured: 3 and 6 months
Secondary outcomes (7)
Achilles tendon pressure measuring until pain release.
Measured: 3 and 6 months
Pain while resting.
Measured: 3 and 6 months
Patient evaluation of treatment efficacy
Measured: 3 and 6 months
FAOS
Measured: 3 and 6 months
AOFAS
Measured: 3 and 6 months
Number of neo-vascularisation.
Measured: day 0, 1 and 3 months
Localisation of the neo-vascularisation
Measured: day 0, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJan 2009
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 Chronic Achilles 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ole Simonsen, MD, DMSci, Principal investigator, Northern Orthopaedic Division, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377910
- Sponsor's protocol ID
- ON-02-012-OSi
- Status last verified
- Mar 2014
- First submitted
- 18 Sep 2006
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. doi: 10.1007/s00167-004-0585-6. Epub 2005 Feb 2.
PubMed 15688235
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
- ClinicalTrials.gov ID
- NCT00377910
- Acronym / sponsor ID
- ON-02-012-OSi
- Conditions
- Chronic Achilles Tendinopathy
- Keywords
- Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2006 (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.
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
Detailed description
48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, drug | Active comparator | Drug: AethoxysclerolInjections of polidocanol |
| 2 drug | Placebo comparator | Drug: Aethoxysclerolinjections of lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive
Key exclusion criteria (1 listed)
- Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,
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 |
|---|---|---|
| AethoxysclerolAlso: 1. drug: Polidocanol, 2. drug: Lidocaine2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml | Drug | 1, drug, 2 drug |
Primary outcome
Pain during physical activity which usually causes pain
Time frame: 3 and 6 months
7 secondary outcomes
Achilles tendon pressure measuring until pain release.
Time frame: 3 and 6 months
Pain while resting.
Time frame: 3 and 6 months
Patient evaluation of treatment efficacy
Time frame: 3 and 6 months
FAOS
Time frame: 3 and 6 months
AOFAS
Time frame: 3 and 6 months
Number of neo-vascularisation.
Time frame: day 0, 1 and 3 months
Localisation of the neo-vascularisation
Time frame: day 0, 1 and 3 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 31 Mar 2014.
- Background: PubMed 15688235Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. doi: 10.1007/s00167-004-0585-6. Epub 2005 Feb 2.
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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.
Ole Simonsen, MD, DMSci principal investigator
Northern Orthopaedic Division, Denmark
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 Aethoxysclerol in people with Chronic Achilles Tendinopathy, run by Northern Orthopaedic Division, Denmark 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 1 inclusion and 1 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 31 Mar 2014. 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.
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?
Pain during physical activity which usually causes pain (time frame: 3 and 6 months). 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 NCT00377910, 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 31 Mar 2014.