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

Study Overview
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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.

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.

Official Title
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Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.

Conditions
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Chronic Achilles Tendinopathy

Intervention / Treatment
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* Drug: Aethoxysclerol


Participation Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1, drug<br>Injections of polidocanol | Drug: Aethoxysclerol<br>* 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml<br>* Other names: 2. drug: Lidocaine;|
| Placebo Comparator: 2 drug<br>injections of lidocaine | Drug: Aethoxysclerol<br>* 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml<br>* Other names: 2. drug: Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during physical activity which usually causes pain |  | 3 and 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT