Treatment for Achilles Tendinopathy

Achilles Tendinopathy Clinical Trial

Official title:

Treatment for Achilles Tendinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00835939
• Other study ID #: UC-20903-RR
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 3, 2009
• Last updated: February 3, 2009
• Start date: September 2007

Study information

• Verified date: February 2009
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Achilles Tendon Enthesopathy
• Insertional Achilles Tendinopathy
• Mid-Portion Achilles Tendinopathy
• Non-Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Drug:
• 25% Dextrose and 1% Lidocaine
Up to 3 injections provided to neovessels outside of the tendon
• Lidocaine
Up to 3 injections provided to neovessels outside of the tendon

Procedure:
• sclerotherapy

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Sport Science Association of Alberta (SSAA)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute for Sport Assessment - Achilles		Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year	No
Secondary	100 mm Visual Analog Scale		Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year	No
Secondary	Tegner Activity Scale		Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year	No
Secondary	Number of Neovessels		Baseline, 4 weeks, 8 weeks, 12 weeks	No