The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy

Phase 4

Completed

• Conditions: Chronic Achilles Tendinopathy
• Interventions: Drug: Aethoxysclerol

• Registration Number: NCT00377910
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief 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.

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.

Study Timeline

• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-19
• Study Start: 2008-03
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1, drug	Aethoxysclerol	Injections of polidocanol
2 drug	Aethoxysclerol	injections of lidocaine

Primary Outcome Measures

Name	Time	Method
Pain during physical activity which usually causes pain	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Patient evaluation of treatment efficacy	3 and 6 months
AOFAS	3 and 6 months
Number of neo-vascularisation.	day 0, 1 and 3 months
Achilles tendon pressure measuring until pain release.	3 and 6 months
FAOS	3 and 6 months
Pain while resting.	3 and 6 months
Localisation of the neo-vascularisation	day 0, 1 and 3 months

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark