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

• ClinicalTrials.gov Identifier: NCT01668953
• Recruitment Status: Active, not recruiting
• First Posted: August 20, 2012
• Last Update Posted: April 13, 2022
• Sponsor: McMaster University
• Collaborators: Arthrex, Inc.; The Physicians' Services Incorporated Foundation; Radiological Society of North America
• Information provided by (Responsible Party): McMaster University

Study Description

Brief Summary:

"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.

Condition or disease	Intervention/treatment	Phase
Lateral Epicondylitis (Tennis Elbow)	Other: Platelet Rich Plasma (PRP) Injection; Other: Whole Blood Injection; Other: Dry Needle Fenestration; Other: Sham Injection	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
• Study Start Date: August 2012
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Pain Reduction [ Time Frame: Baseline, 6 weeks, 3, 6, 12 months ]
   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).

Secondary Outcome Measures :

1. Functional Disability [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]
   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.
2. Psychological Impairment [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]
   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.
3. Health-Related Quality of Life [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]
   Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109-5326

Canada, Ontario

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Sponsors and Collaborators

McMaster University

Arthrex, Inc.

The Physicians' Services Incorporated Foundation

Radiological Society of North America

Investigators

• Principal Investigator: Mary M Chiavaras, MD, PhD; McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT01668953
• Obsolete Identifiers: NCT01789632
• Other Study ID Numbers: IMPROVE-001; Research Seed Grant # 1204 ( Other Grant/Funding Number: Radiological Society of North America (RSNA) )
• First Posted: August 20, 2012
• Last Update Posted: April 13, 2022
• Last Verified: April 2022

Keywords provided by McMaster University:

Lateral Epicondylitis; Tennis Elbow; Platelet Rich Plasma; Whole Blood; Tendon Fenestration

Additional relevant MeSH terms:

Tennis Elbow; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Arm Injuries; Wounds and Injuries; Tendon Injuries