Clinical trial NCT00835939: Treatment for Achilles Tendinopathy
Official title: Treatment for Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: 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
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Sport Science Association of Alberta (SSAA)
First posted: 2009-02-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Victorian Institute for Sport Assessment - Achilles
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes:
measure: 100 mm Visual Analog Scale
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
measure: Tegner Activity Scale
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
measure: Number of Neovessels
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: J Preston Wiley, MD, MPE
role: PRINCIPAL_INVESTIGATOR
References: