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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00377910
• Date of registration: 18/09/2006
• Prospective Registration: Yes
• Primary sponsor: Northern Orthopaedic Division, Denmark
• Public title: The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy
• Scientific title: Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
• Date of first enrolment: March 2008
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00377910
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Ole Simonsen, MD, DMSci
• Affiliation: Northern Orthopaedic Division, Denmark

Key inclusion & exclusion 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,



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Achilles Tendinopathy

Intervention(s)

Drug: Aethoxysclerol

Primary Outcome(s)

Pain during physical activity which usually causes pain [Time Frame: 3 and 6 months]

Secondary Outcome(s)

Patient evaluation of treatment efficacy [Time Frame: 3 and 6 months]

Number of neo-vascularisation. [Time Frame: day 0, 1 and 3 months]

AOFAS [Time Frame: 3 and 6 months]

Achilles tendon pressure measuring until pain release. [Time Frame: 3 and 6 months]

FAOS [Time Frame: 3 and 6 months]

Localisation of the neo-vascularisation [Time Frame: day 0, 1 and 3 months]

Pain while resting. [Time Frame: 3 and 6 months]

Secondary ID(s)

ON-02-012-OSi

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital