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

Lateral Epicondylitis (Tennis Elbow) Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01668953
• Other study ID #: IMPROVE-001
• Secondary ID: Research Seed Gr
• Status: Terminated
• Phase: N/A
• Start date: August 2012
• Est. completion date: April 2023

Study information

• Verified date: April 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01789632

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lateral Epicondylitis (Tennis Elbow)
• Tennis Elbow

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Arthrex, Inc., Radiological Society of North America, The Physicians' Services Incorporated Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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