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Treatment for Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy, Achilles Tendon Enthesopathy, Mid-Portion Achilles Tendinopathy

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

25% Dextrose and 1% Lidocaine

Lidocaine

sclerotherapy

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles, Tendinopathy, Sclerotherapy, Neovascularisation, sports medicine, interventional radiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

25% Dextrose and 1% Lidocaine

Lidocaine

Arm Description

Outcomes

Primary Outcome Measures

Victorian Institute for Sport Assessment - Achilles

Secondary Outcome Measures

100 mm Visual Analog Scale

Tegner Activity Scale

Number of Neovessels

Full Information

NCT ID

NCT00835939

First Posted

February 3, 2009

Last Updated

February 3, 2009

Sponsor

University of Calgary

Collaborators

Sport Science Association of Alberta (SSAA)

1. Study Identification

Unique Protocol Identification Number

NCT00835939

Brief Title

Treatment for Achilles Tendinopathy

Official Title

Treatment for Achilles Tendinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

Collaborators

Sport Science Association of Alberta (SSAA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Achilles, Tendinopathy, Sclerotherapy, Neovascularisation, sports medicine, interventional radiology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

25% Dextrose and 1% Lidocaine

Arm Type

Active Comparator

Arm Title

Lidocaine

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

25% Dextrose and 1% Lidocaine

Intervention Description

Up to 3 injections provided to neovessels outside of the tendon

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

Up to 3 injections provided to neovessels outside of the tendon

Intervention Type

Procedure

Intervention Name(s)

sclerotherapy

Primary Outcome Measure Information:

Title

Victorian Institute for Sport Assessment - Achilles

Time Frame

Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Secondary Outcome Measure Information:

Title

100 mm Visual Analog Scale

Time Frame

Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Title

Tegner Activity Scale

Time Frame

Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Title

Number of Neovessels

Time Frame

Baseline, 4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Preston Wiley, MD, MPE

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 1N4

Country

Canada

12. IPD Sharing Statement

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Treatment for Achilles Tendinopathy

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