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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377910

Enrollment

Registered

2006-09-19

Start date

2008-03-31

Completion date

2009-01-31

Last updated

2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Achilles Tendinopathy

Keywords

Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT

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.

Interventions

DRUGAethoxysclerol

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame
Pain during physical activity which usually causes pain	3 and 6 months

Secondary

Measure	Time frame
Pain while resting.	3 and 6 months
Patient evaluation of treatment efficacy	3 and 6 months
FAOS	3 and 6 months
Achilles tendon pressure measuring until pain release.	3 and 6 months
Number of neo-vascularisation.	day 0, 1 and 3 months
Localisation of the neo-vascularisation	day 0, 1 and 3 months
AOFAS	3 and 6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026