| September 18, 2006 |
| February 12, 2009 |
| February 2007 |
| January 2010 (final data collection date for primary outcome measure) |
| Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ] |
| Pain during physical activity which usually causes pain |
| Complete list of historical versions of study NCT00377910 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Achilles tendon pressure measuring until pain release.
- Pain while resting.
- Patient evaluation of treatment efficacy
- FAOS
- AOFAS
- Number of neo-vascularisation.
- Localisation of the neo-vascularisation
|
| |
| Placebo-Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy |
| 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 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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Efficacy Study |
| Chronic Achilles Tendinopathy |
| Drug: Aethoxysclerol |
- Active Comparator: Injections of polidocanol
- Placebo Comparator: injections of lidocain
|
| 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. |
| |
| Recruiting |
| 48 |
| February 2010 |
| January 2010 (final data collection date for primary outcome measure) |
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 pregnancytest, 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,
|
| Both |
| 18 Years and older |
| No |
| Contact: Kirsten Ø Christensen, MD |
004599321111 |
kooc@rn.dk |
|
|
| Denmark |
| |
| NCT00377910 |
| Kirsten Ø Christensen, Northern Orthopaedic Division, Denmark |
| ON-02-012-OSi |
| Northern Orthopaedic Division, Denmark |
| University of Aarhus |
| Principal Investigator: |
Ole Simonsen, MD, DMSci |
Northern Orthopaedic Division, Denmark |
|
|
| Northern Orthopaedic Division, Denmark |
| February 2009 |
