Treatment for Achilles Tendinopathy

February 3, 2009 updated by: University of Calgary
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 3

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Victorian Institute for Sport Assessment - Achilles
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
100 mm Visual Analog Scale
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Tegner Activity Scale
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Number of Neovessels
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Sport Science Association of Alberta (SSAA)

Investigators

  • Principal Investigator: J Preston Wiley, MD, MPE, University of Calgary

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

September 1, 2007

Primary Completion (Anticipated)

January 1, 2010

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-20903-RR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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