Lateral Epicondylitis (Tennis Elbow)
Conditions
Brief summary
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
Interventions
BIOLOGICALAutologous Human Platelet Lysate
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
DRUGCorticosteroid
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Sponsors
Kasiak Research Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with clinical diagnosis of tennis elbow within the last 3 months * Subjects both male and female, aged 18-60 years (both inclusive) * Subjects who are willing to give informed consent and adhere to the study protocol
Exclusion criteria
* Subjects aged less than 18 and more than 60 years * Subjects with autoimmune diseases * Subjects with immuno-compromised system * Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin * Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons. * Subjects who have received treatment with corticosteroid injections within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Visual Analog Score (VAS) | Day 0, Month 1, Month 2, End of Study - Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3 | Day 0, End of study - Month 3 |
Other
| Measure | Time frame |
|---|---|
| Patient rated tennis elbow evaluation (PRTEE Score) | Day 0, Month 1, Month 2, End of study-Month 3 |
| The American Shoulder and Elbow Society score | Dya 0, Month 1, Month 2, End of study-Month 3 |
Countries
India
Contacts
Primary ContactKaushal Shah, Phd
Outcome results
None listed