Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE)

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

"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.

Study Overview

• Status: Terminated
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Other: Platelet Rich Plasma (PRP) Injection; Other: Whole Blood Injection; Other: Dry Needle Fenestration; Other: Sham Injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5326
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult man or woman aged 18 years or greater.
• 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.
• Chronic symptoms (equal or greater than 3 months).
• Pain of at least 5 out of 10 on a visual analog scale (VAS).
• Provision of informed consent.

Exclusion Criteria:

• Acute symptom onset (less than 2 months).
• History of acute elbow trauma (less than one week).
• History of rheumatoid arthritis.
• History of malignancy.
• Pregnancy
• Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
• Previous surgery for lateral epicondylitis.
• Previous local injections, including steroids within the past 6 months.
• Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma (PRP) Injection; 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; The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.; 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.; 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.; Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.; The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
Active Comparator: Whole Blood 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; The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.; 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.; 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.; Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.; The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
Active Comparator: Dry Needle Fenestration; 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; The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.; 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.; A 22-gauge needle will then be placed into the tendon.; 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.
Placebo Comparator: Sham Injection; 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; The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.; 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.; The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 6 weeks, 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Baseline, 6 weeks, 3, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Arthrex, Inc.; The Physicians' Services Incorporated Foundation; Radiological Society of North America
• Investigators: Principal Investigator: Mary M Chiavaras, MD, PhD, McMaster University

Publications and helpful links

General Publications

• Syrjala KL, Walsh CA, Yi JC, Leisenring WM, Rajotte EJ, Voutsinas J, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Baker KS. Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms. J Cancer Surviv. 2022 Oct;16(5):1149-1164. doi: 10.1007/s11764-021-01105-8. Epub 2021 Sep 29.
• Hall AG, Syrjala KL, Ketterl TG, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Rajotte EJ, Mueller BA, Baker KS. Socioeconomic Factors and Adherence to Health Care Recommendations in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2023 Feb 13. doi: 10.1089/jayao.2022.0109. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lateral Epicondylitis; Platelet Rich Plasma; Whole Blood; Tendon Fenestration; Tennis Elbow
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: IMPROVE-001; Research Seed Grant # 1204 (Other Grant/Funding Number: Radiological Society of North America (RSNA))