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OpenTrials
Completed

NCT Number: NCT00377910

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

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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Key information

Conditions

Chronic Achilles Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital

Aalborg, 9100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Aethoxysclerol

Drug

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

Other names: 1. drug: Polidocanol, 2. drug: Lidocaine

Primary outcomes

  1. Pain during physical activity which usually causes pain

    Time frame: 3 and 6 months

Secondary outcomes

  1. Achilles tendon pressure measuring until pain release.

    Time frame: 3 and 6 months

  2. Pain while resting.

    Time frame: 3 and 6 months

  3. Patient evaluation of treatment efficacy

    Time frame: 3 and 6 months

  4. FAOS

    Time frame: 3 and 6 months

  5. AOFAS

    Time frame: 3 and 6 months

  6. Number of neo-vascularisation.

    Time frame: day 0, 1 and 3 months

  7. Localisation of the neo-vascularisation

    Time frame: day 0, 1 and 3 months

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2006
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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