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Sponsors and Collaborators: |
Northern Orthopaedic Division, Denmark University of Aarhus |
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Information provided by: | Northern Orthopaedic Division, Denmark |
ClinicalTrials.gov Identifier: | NCT00377910 |
Chronic Achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercise, but with varying success.A new hypothesis is that this chronic pain is due to neo vascularisation, and in a pilot study, sclerosing injections with polidocanol has been successfully used. The aim of our study is to try the hypothesis and the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
Condition | Intervention | Phase |
---|---|---|
Chronic Achilles Tendinopathy |
Drug: Aethoxysclerol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy |
Estimated Enrollment: | 48 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Arms | Assigned Interventions |
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1, drug: Active Comparator
Injections of polidocanol
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Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml
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2 drug: Placebo Comparator
injections of lidocain
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Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml
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48 patients with Chronic achilles tendinopathy for more than 3 month,who have tried excentric exercise without success, will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kirsten Ø Christensen, MD | 004599321111 | kooc@rn.dk |
Denmark | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 9100 | |
Contact: Kirsten Ø Christensen, MD kooc@rn.dk | |
Contact: Kirsten Ø Christensen, MD +4599321111 kooc@rn.dk | |
Principal Investigator: Henrik E Gregersen, MD,consultant | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 9100 | |
Contact: Kirsten Ø Christensen, MD ki.c@jubii.dk | |
Contact: Kirsten Ø Christensen, MD +4599321111 kooc@rn.dk | |
Principal Investigator: Henrik E Gregersen, MD,consultant |
Principal Investigator: | Ole Simonsen, MD, DMSci | Northern Orthopaedic Division, Denmark |
Responsible Party: | Northern Orthopaedic Division, Denmark ( Kirsten Ø Christensen ) |
Study ID Numbers: | ON-02-012-OSi |
Study First Received: | September 18, 2006 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00377910 |
Health Authority: | Denmark: Danish Medicines Agency |
Chronic Achilles tendinopathy Polidocanol Ultrasound Efficacy RCT |
Tendinopathy Tendon Injuries Muscular Diseases Musculoskeletal Diseases |
Wounds and Injuries Polidocanol Disorders of Environmental Origin |
Therapeutic Uses Sclerosing Solutions Cardiovascular Agents Pharmacologic Actions |