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

March 28, 2014 updated by: Northern Orthopaedic Division, Denmark

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain during physical activity which usually causes pain
Time Frame: 3 and 6 months
3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Ole Simonsen, MD, DMSci, Northern Orthopaedic Division, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (ESTIMATE)

September 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-02-012-OSi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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