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Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE Trial)
N/A
Waitlist Available
Led By Mary M Chiavaras, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3, 6, 12, 24 months
Summary
This trial will compare four different treatments for tennis elbow: platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy).
Eligible Conditions
- Tennis Elbow
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 3, 6, 12, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3, 6, 12, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Reduction
Secondary study objectives
Functional Disability
Health-Related Quality of Life
Psychological Impairment
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Platelet Rich Plasma (PRP) InjectionExperimental Treatment1 Intervention
Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
Group II: Whole Blood InjectionActive Control1 Intervention
Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
Group III: Dry Needle FenestrationActive Control1 Intervention
Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
Group IV: Sham InjectionPlacebo Group1 Intervention
Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
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Who is running the clinical trial?
Radiological Society of North AmericaOTHER
26 Previous Clinical Trials
906 Total Patients Enrolled
Arthrex, Inc.Industry Sponsor
46 Previous Clinical Trials
29,872 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,294 Total Patients Enrolled
McMaster UniversityLead Sponsor
918 Previous Clinical Trials
2,616,193 Total Patients Enrolled
Mary M Chiavaras, MD, PhDPrincipal InvestigatorMcMaster University