Trial | NCT00835939  Report issue

Official Title

Treatment for Achilles Tendinopathy

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    17
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.
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 Started
Sep 30
2007
Primary Completion
Jan 31
2010
Anticipated
Last Update
Feb 04
2009
Estimate

Drug 25% Dextrose and 1% Lidocaine

Up to 3 injections provided to neovessels outside of the tendon

Drug Lidocaine

Up to 3 injections provided to neovessels outside of the tendon

Procedure sclerotherapy

25% Dextrose and 1% Lidocaine Active Comparator

Lidocaine Placebo Comparator

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
No Results Posted