Chronic Achilles Tendinopathy Clinical Trial
Official title:
Placebo Controlled Trial, Testing 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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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, |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg University Hospital | Aalborg |
| Lead Sponsor | Collaborator |
|---|---|
| Northern Orthopaedic Division, Denmark | Aarhus University Hospital |
Denmark,
Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. Epub 2005 Feb 2. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain during physical activity which usually causes pain | 3 and 6 months | No | |
| Secondary | Achilles tendon pressure measuring until pain release. | 3 and 6 months | No | |
| Secondary | Pain while resting. | 3 and 6 months | No | |
| Secondary | Patient evaluation of treatment efficacy | 3 and 6 months | No | |
| Secondary | FAOS | 3 and 6 months | No | |
| Secondary | AOFAS | 3 and 6 months | No | |
| Secondary | Number of neo-vascularisation. | day 0, 1 and 3 months | Yes | |
| Secondary | Localisation of the neo-vascularisation | day 0, 1 and 3 months | No |