The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy
Information source: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Achilles Tendinopathy
Intervention: Aethoxysclerol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Northern Orthopaedic Division, Denmark Official(s) and/or principal investigator(s): Ole Simonsen, MD, DMSci, Principal Investigator, Affiliation: Northern Orthopaedic Division, Denmark
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. 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.
Clinical Details
Official title: Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Pain during physical activity which usually causes pain
Secondary outcome: Achilles tendon pressure measuring until pain release.Pain while resting. Patient evaluation of treatment efficacy FAOS AOFAS Number of neo-vascularisation. Localisation of the neo-vascularisation
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
Locations and Contacts
Aalborg University Hospital, Aalborg 9100, Denmark
Additional Information
Related 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. Epub 2005 Feb 2.
Starting date: March 2008
Last updated: March 28, 2014
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