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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

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.

Condition or disease Intervention/treatment Phase
Chronic Achilles Tendinopathy Drug: Aethoxysclerol Phase 4

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  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377910


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

Publications:
Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00377910     History of Changes
Other Study ID Numbers: ON-02-012-OSi
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
Chronic Achilles tendinopathy
Polidocanol
Ultrasound
Efficacy
RCT

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Lidocaine
Polidocanol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sclerosing Solutions
Pharmaceutical Solutions