Treatment for Achilles Tendinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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25% Dextrose and 1% Lidocaine

Group Type ACTIVE_COMPARATOR

25% Dextrose and 1% Lidocaine

Intervention Type DRUG

Up to 3 injections provided to neovessels outside of the tendon

sclerotherapy

Intervention Type PROCEDURE

Lidocaine

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

Up to 3 injections provided to neovessels outside of the tendon

Interventions

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25% Dextrose and 1% Lidocaine

Up to 3 injections provided to neovessels outside of the tendon

Intervention Type DRUG

Lidocaine

Up to 3 injections provided to neovessels outside of the tendon

Intervention Type DRUG

sclerotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes