Treatment for Achilles Tendinopathy
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Achilles Tendinopathy Achilles Tendon Enthesopathy Mid-Portion Achilles Tendinopathy Insertional Achilles Tendinopathy Non-Insertional Achilles Tendinopathy |
Drug: 25% Dextrose and 1% Lidocaine Drug: Lidocaine Procedure: sclerotherapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment for Achilles Tendinopathy |
- Victorian Institute for Sport Assessment - Achilles [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
- 100 mm Visual Analog Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
- Tegner Activity Scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
- Number of Neovessels [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 25% Dextrose and 1% Lidocaine |
Drug: 25% Dextrose and 1% Lidocaine
Up to 3 injections provided to neovessels outside of the tendon
Procedure: sclerotherapy
|
| Placebo Comparator: Lidocaine |
Drug: Lidocaine
Up to 3 injections provided to neovessels outside of the tendon
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Principal Investigator: | J Preston Wiley, MD, MPE | University of Calgary |
More Information
No publications provided
| Responsible Party: | Dr. J Preston Wiley, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00835939 History of Changes |
| Other Study ID Numbers: | UC-20903-RR |
| Study First Received: | February 3, 2009 |
| Last Updated: | February 3, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
Achilles Tendinopathy Sclerotherapy |
Neovascularisation sports medicine interventional radiology |
Additional relevant MeSH terms:
|
Rheumatic Diseases Tendinopathy Musculoskeletal Diseases Connective Tissue Diseases Muscular Diseases Tendon Injuries Wounds and Injuries Lidocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013