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

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ClinicalTrials.gov Identifier: NCT00377910
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : March 31, 2014
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date  ICMJE September 18, 2006
First Posted Date  ICMJE September 19, 2006
Last Update Posted Date March 31, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
Pain during physical activity which usually causes pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
  • Achilles tendon pressure measuring until pain release. [ Time Frame: 3 and 6 months ]
  • Pain while resting. [ Time Frame: 3 and 6 months ]
  • Patient evaluation of treatment efficacy [ Time Frame: 3 and 6 months ]
  • FAOS [ Time Frame: 3 and 6 months ]
  • AOFAS [ Time Frame: 3 and 6 months ]
  • Number of neo-vascularisation. [ Time Frame: day 0, 1 and 3 months ]
  • Localisation of the neo-vascularisation [ Time Frame: day 0, 1 and 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
  • Achilles tendon pressure measuring until pain release.
  • Pain while resting.
  • Patient evaluation of treatment efficacy
  • FAOS
  • AOFAS
  • Number of neo-vascularisation.
  • Localisation of the neo-vascularisation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy
Official Title  ICMJE Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Achilles Tendinopathy
Intervention  ICMJE Drug: Aethoxysclerol
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
Other Names:
  • 1. drug: Polidocanol
  • 2. drug: Lidocaine
Study Arms  ICMJE
  • Active Comparator: 1, drug
    Injections of polidocanol
    Intervention: Drug: Aethoxysclerol
  • Placebo Comparator: 2 drug
    injections of lidocaine
    Intervention: Drug: Aethoxysclerol
Publications * Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. Epub 2005 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2006)
48
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377910
Other Study ID Numbers  ICMJE ON-02-012-OSi
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor  ICMJE Northern Orthopaedic Division, Denmark
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Ole Simonsen, MD, DMSci Northern Orthopaedic Division, Denmark
PRS Account Northern Orthopaedic Division, Denmark
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP