Treatment for Achilles Tendinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Calgary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sport Science Association of Alberta (SSAA)
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00835939
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1% lidocaine solution is an efficacious treatment for patients with chronic Achilles tendinopathy who have failed a home based, heavy load eccentric training program.


Condition Intervention Phase
Achilles Tendinopathy
Achilles Tendon Enthesopathy
Mid-Portion Achilles Tendinopathy
Insertional Achilles Tendinopathy
Non-Insertional Achilles Tendinopathy
Drug: 25% Dextrose and 1% Lidocaine
Drug: Lidocaine
Procedure: sclerotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Achilles Tendinopathy

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Victorian Institute for Sport Assessment - Achilles [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 100 mm Visual Analog Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Tegner Activity Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Number of Neovessels [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2007
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 25% Dextrose and 1% Lidocaine Drug: 25% Dextrose and 1% Lidocaine
Up to 3 injections provided to neovessels outside of the tendon
Procedure: sclerotherapy
Placebo Comparator: Lidocaine Drug: Lidocaine
Up to 3 injections provided to neovessels outside of the tendon

Detailed Description:

The purpose of this research project is to optimize the clinical outcome of patients with Achilles tendinopathy. Patients who fail a standardized physical therapy regiment (eccentric training protocol) will be randomly allocated into two groups with one group receiving an injection of hypertonic glucose and Lidocaine (sclerosing solution) and the other receiving an injection of Lidocaine (control). Neovascularisation (growth of new blood vessels and nerves into a damaged area of the tendon) appears to be associated with pain and subsequently a decrease in function and use of the affected tendon. Results of an observational study in Sweden revealed that in all patients for which eccentric training was unsuccessful neovascularisation was present. Sclerosis of neovessels appears to be successful in removing the pain associated with Achilles tendinopathy in both mid-portion and enthesitis patients. However, there are no studies that have administered this technique to a homogenous patient population in a prospective, controlled and randomized manner. In addition, there are no studies that have compared the effects of eccentric training in healthy individuals versus patients with painful Achilles tendinopathy in a controlled longitudinal study. It is expected that patients for whom eccentric training is unsuccessful and who subsequently receive sclerosing therapy will show a statistically significant improvement in pain and function.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician.
  • Participants are not required to have tried other treatments, however, those who have tried other treatments (except injection treatments) including, but not restricted to, oral NSAIDs, topical NSAIDs, shoe modifications, and physical/athletic therapy will not be restricted from the study
  • Provide informed consent for the controlled longitudinal study and RCT

Exclusion Criteria:

  • Individuals with physical ailments precluding them from performing the eccentric training program
  • Worker's Compensation Board (WCB) and elite athletes (varsity, national and professional level).
  • Individuals younger than 18 years of age will be excluded from this trial due to the complicating factors of musculoskeletal immaturity and the lack of relevant research of Achilles tendinopathy and neovascular bundles in this population.
  • Previous Achilles tendon rupture of the tendon in question
  • Individuals that have received any type of injection in or around the Achilles tendon
  • Known allergy to dextrose based sclerosing agent or other contraindications
  • Known allergy to Lidocaine
  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: NCT00835939

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Sport Science Association of Alberta (SSAA)
Investigators
Principal Investigator: J Preston Wiley, MD, MPE University of Calgary
  More Information

No publications provided

Responsible Party: Dr. J Preston Wiley, University of Calgary
ClinicalTrials.gov Identifier: NCT00835939     History of Changes
Other Study ID Numbers: UC-20903-RR
Study First Received: February 3, 2009
Last Updated: February 3, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Achilles
Tendinopathy
Sclerotherapy
Neovascularisation
sports medicine
interventional radiology

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

ClinicalTrials.gov processed this record on August 21, 2014