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

N

Northern Orthopaedic Division, Denmark

Status and phase

Completed
Phase 4

Conditions

Chronic Achilles Tendinopathy

Treatments

Drug: Aethoxysclerol

Study type

Interventional

Funder types

Other

Identifiers

NCT00377910
ON-02-012-OSi

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No 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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

48 participants in 2 patient groups, including a placebo group

1, drug
Active Comparator group
Description:
Injections of polidocanol
Treatment:
Drug: Aethoxysclerol
2 drug
Placebo Comparator group
Description:
injections of lidocaine
Treatment:
Drug: Aethoxysclerol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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