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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

Page last updated: August 23, 2015

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