An interventional study of Platelet Rich Plasma (PRP) Injection and Whole Blood Injection in Lateral Epicondylitis (Tennis Elbow), sponsored by McMaster University. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
"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.
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
Other: Platelet Rich Plasma (PRP) Injection
Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
Other: Whole Blood Injection
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.
Other: Dry Needle Fenestration
Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
Other: Sham Injection
1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic. 2. A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites. 3. For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used. 4. Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon. 5. The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic. 2. A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites. 3. 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle. 4. Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon. 5. The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic. 2. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded. 3. A 22-gauge needle will then be placed into the tendon. 4. 15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon.
1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic. 2. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded. 3. The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.
Pain Reduction
Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).
Time frame: Baseline, 6 weeks, 3, 6, 12 months
Functional Disability
Functional disability will be measured using the Liverpool Elbow Score (LES) which is an assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
Psychological Impairment
Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression.
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
Health-Related Quality of Life
Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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