Treatment for Achilles Tendinopathy

Phase

2/3

Condition

Sprains

Tendon Injuries

Treatment

N/A

Clinical Study ID

NCT00835939

UC-20903-RR

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults 18 years of age and older with a minimum of 3 months of clinically determinanthistory 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 havetried other treatments (except injection treatments) including, but not restricted to,oral NSAIDs, topical NSAIDs, shoe modifications, and physical/athletic therapy willnot be restricted from the study
Provide informed consent for the controlled longitudinal study and RCT

Exclusion

Exclusion Criteria:

Individuals with physical ailments precluding them from performing the eccentrictraining program
Worker's Compensation Board (WCB) and elite athletes (varsity, national andprofessional level).
Individuals younger than 18 years of age will be excluded from this trial due to thecomplicating factors of musculoskeletal immaturity and the lack of relevant researchof 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 Design

September 01, 2007

Study 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.

Connect with a study center

University of Calgary
Calgary, Alberta T2N 1N4
Canada
Site Not Available

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