Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
Overview
- Phase
- Phase 4
- Intervention
- Aethoxysclerol
- Conditions
- Chronic Achilles Tendinopathy
- Sponsor
- Northern Orthopaedic Division, Denmark
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pain during physical activity which usually causes pain
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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,
Arms & Interventions
2 drug
injections of lidocaine
Intervention: Aethoxysclerol
1, drug
Injections of polidocanol
Intervention: Aethoxysclerol
Outcomes
Primary Outcomes
Pain during physical activity which usually causes pain
Time Frame: 3 and 6 months
Secondary Outcomes
- 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)