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.
Primary Outcome Measures:
- Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Achilles tendon pressure measuring until pain release. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Pain while resting. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Patient evaluation of treatment efficacy [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- FAOS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- AOFAS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Number of neo-vascularisation. [ Time Frame: day 0, 1 and 3 months ] [ Designated as safety issue: Yes ]
- Localisation of the neo-vascularisation [ Time Frame: day 0, 1 and 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
48 |
| Study Start Date: |
February 2007 |
| Estimated Study Completion Date: |
February 2010 |
|
1, drug: Active Comparator
Injections of polidocanol
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Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml
|
|
2 drug: Placebo Comparator
injections of lidocain
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Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml
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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.
Purpose
