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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00377910
First received: September 18, 2006
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov 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
Polidocanol
Ultrasound
Efficacy
RCT

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

ClinicalTrials.gov processed this record on October 23, 2014