Treatment for Achilles Tendinopathy

Study Overview
=================
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.

Official Title
-----------------
Treatment for Achilles Tendinopathy

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

Intervention / Treatment
-----------------
* Drug: 25% Dextrose and 1% Lidocaine
* Drug: Lidocaine
* Procedure: sclerotherapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25% Dextrose and 1% Lidocaine<br> | Drug: 25% Dextrose and 1% Lidocaine<br>* Up to 3 injections provided to neovessels outside of the tendon<br>Procedure: sclerotherapy<br> <br> |
| Placebo Comparator: Lidocaine<br> | Drug: Lidocaine<br>* Up to 3 injections provided to neovessels outside of the tendon<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute for Sport Assessment - Achilles |  | Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles, Tendinopathy, Sclerotherapy, Neovascularisation, sports medicine, interventional radiology