Suspended

IMPROVEImpact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Platelet Rich Plasma (PRP) Injection

+ Whole Blood Injection

+ Dry Needle Fenestration

Other
Who is being recruted

Elbow Tendinopathy+6

+ Elbow Injuries

+ Arm Injuries

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorMcMaster University
Last updated: April 10, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow. Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique. At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment. The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.

NCT01668953NCT01789632
Principal SponsorMcMaster University
Last updated: April 10, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Elbow TendinopathyElbow InjuriesArm InjuriesMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesTendinopathyTennis Elbow

Criteria

6 inclusion criteria required to participate
Adult man or woman aged 18 years or greater

Chronic symptoms (equal or greater than 3 months)

Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension

Documented sonographic diagnosis of common extensor tendinosis based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture

Show More Criteria

9 exclusion criteria prevent from participating
Acute symptom onset (less than 2 months)

History of acute elbow trauma (less than one week)

History of malignancy

History of rheumatoid arthritis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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

Active Comparator
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

Active Comparator
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

Placebo
Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Michigan

Ann Arbor, United StatesOpen University of Michigan in Google Maps

Hamilton General Hospital

Hamilton, Canada
Suspended2 Study Centers