Treatment for Achilles Tendinopathy

Phase 2

• Conditions: Achilles Tendinopathy; Achilles Tendon Enthesopathy; Mid-Portion Achilles Tendinopathy; Insertional Achilles Tendinopathy; Non-Insertional Achilles Tendinopathy
• Interventions: Drug: 25% Dextrose and 1% Lidocaine; Drug: Lidocaine; Procedure: sclerotherapy

• Registration Number: NCT00835939
• Lead Sponsor: University of Calgary

Brief 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.

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 Timeline

• Study Start: 2007-09
• Status Verified: 2009-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Last Update Submitted: 2009-02-03
• Study First Posted: 2009-02-04
• Last Update Posted: 2009-02-04
• Primary Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25% Dextrose and 1% Lidocaine	25% Dextrose and 1% Lidocaine	-
25% Dextrose and 1% Lidocaine	sclerotherapy	-
Lidocaine	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
Victorian Institute for Sport Assessment - Achilles	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
100 mm Visual Analog Scale	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Tegner Activity Scale	Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Number of Neovessels	Baseline, 4 weeks, 8 weeks, 12 weeks

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada