Placebo-Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy
Information source: Northern Orthopaedic Division, Denmark
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Achilles Tendinopathy
Intervention: Aethoxysclerol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Northern Orthopaedic Division, Denmark Official(s) and/or principal investigator(s):
Ole Simonsen, MD, DMSci, Principal Investigator, Affiliation: Northern Orthopaedic Division, Denmark
Overall contact:
Kirsten Ø Christensen, MD, Phone: 004599321111, Email: kooc@rn.dk
Summary
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.
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 month,who have tried
excentric exercise 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 pregnancytest, 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
Kirsten Ø Christensen, MD, Phone: 004599321111, Email: kooc@rn.dk
Aalborg University Hospital, Aalborg 9100, Denmark; Recruiting
Kirsten Ø Christensen, MD, Email: kooc@rn.dk
Kirsten Ø Christensen, MD, Phone: +4599321111, Email: kooc@rn.dk
Henrik E Gregersen, MD,consultant, Principal Investigator
Aalborg University Hospital, Aalborg 9100, Denmark; Recruiting
Kirsten Ø Christensen, MD, Email: ki.c@jubii.dk
Kirsten Ø Christensen, MD, Phone: +4599321111, Email: kooc@rn.dk
Henrik E Gregersen, MD,consultant, Principal Investigator
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: February 2007
Last updated: February 12, 2009
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