This trial is active, not recruiting.

Conditions achilles tendinopathy, achilles tendon enthesopathy, mid-portion achilles tendinopathy, insertional achilles tendinopathy, non-insertional achilles tendinopathy
Treatments 25% dextrose and 1% lidocaine, lidocaine, sclerotherapy
Phase phase 2/phase 3
Sponsor University of Calgary
Collaborator Sport Science Association of Alberta (SSAA)
Start date September 2007
End date January 2010
Trial size 17 participants
Trial identifier NCT00835939, UC-20903-RR


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
25% dextrose and 1% lidocaine
Up to 3 injections provided to neovessels outside of the tendon
(Placebo Comparator)
Up to 3 injections provided to neovessels outside of the tendon

Primary Outcomes

Victorian Institute for Sport Assessment - Achilles
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Secondary Outcomes

100 mm Visual Analog Scale
time frame: 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
Number of Neovessels
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Treatment for Achilles Tendinopathy
Principal investigator J Preston Wiley, MD, MPE
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Calgary.