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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, drug | Active Comparator | Injections of polidocanol |
|
| 2 drug | Placebo Comparator | injections of lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aethoxysclerol | Drug | 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during physical activity which usually causes pain | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Achilles tendon pressure measuring until pain release. | 3 and 6 months | |
| Pain while resting. | 3 and 6 months | |
| Patient evaluation of treatment efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole Simonsen, MD, DMSci | Northern Orthopaedic Division, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15688235 | Background | 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. |
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| ID | Term |
|---|---|
| D000077423 | Polidocanol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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| 3 and 6 months |
| FAOS | 3 and 6 months |
| AOFAS | 3 and 6 months |
| Number of neo-vascularisation. | day 0, 1 and 3 months |
| Localisation of the neo-vascularisation | day 0, 1 and 3 months |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |