Treatment for Achilles Tendinopathy
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedFebruary 4, 2009
February 1, 2009
2.3 years
February 3, 2009
February 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Victorian Institute for Sport Assessment - Achilles
Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Secondary Outcomes (3)
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
Study Arms (2)
25% Dextrose and 1% Lidocaine
ACTIVE COMPARATORLidocaine
PLACEBO COMPARATORInterventions
Up to 3 injections provided to neovessels outside of the tendon
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Sport Science Association of Alberta (SSAA)collaborator
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Preston Wiley, MD, MPE
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
September 1, 2007
Primary Completion
January 1, 2010
Last Updated
February 4, 2009
Record last verified: 2009-02