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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1, drug

Injections of polidocanol

Group Type ACTIVE_COMPARATOR

Aethoxysclerol

Intervention Type DRUG

2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml

2 drug

injections of lidocaine

Group Type PLACEBO_COMPARATOR

Aethoxysclerol

Intervention Type DRUG

2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml

Interventions

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Aethoxysclerol

2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml

Intervention Type DRUG

Other Intervention Names

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1. drug: Polidocanol 2. drug: Lidocaine

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No