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

This study has been completed.
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark Identifier:
First received: September 18, 2006
Last updated: March 28, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Chronic Achilles Tendinopathy
Drug: Aethoxysclerol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.

Resource links provided by NLM:

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: March 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, drug
Injections of polidocanol
Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
Other Names:
  • 1. drug: Polidocanol
  • 2. drug: Lidocaine
Placebo Comparator: 2 drug
injections of lidocaine
Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
Other Names:
  • 1. drug: Polidocanol
  • 2. drug: Lidocaine

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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,
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Please refer to this study by its identifier: NCT00377910

Aalborg University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Aarhus University Hospital
Principal Investigator: Ole Simonsen, MD, DMSci Northern Orthopaedic Division, Denmark
  More Information

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT00377910     History of Changes
Other Study ID Numbers: ON-02-012-OSi 
Study First Received: September 18, 2006
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Chronic Achilles tendinopathy

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Cardiovascular Agents
Pharmaceutical Solutions
Pharmacologic Actions
Sclerosing Solutions
Therapeutic Uses processed this record on May 01, 2016