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

Tennis Elbow Clinical Trial

— IMPROVE  

Official title:

Impact of Platelet Rich Plasma Over Alternative Therapies With Lateral Epicondylitis (IMPROVE): A Multicenter, Randomized Trial Comparing Autologous Whole Blood vs. Dry Needle Tendon Fenestration of Pain and Quality of Life in Patients With Lateral Epicondylitis.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01789632
• Other study ID #: HUM00067750
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 14, 2012
• Last updated: December 28, 2017
• Start date: January 2013
• Est. completion date: August 2018

Study information

• Verified date: December 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Pilot study is a Multicenter, Randomized Trial comparing autologous platelet rich plasma (PRP) versus autologous whole blood versus dry needle tendon fenestration on pain and quality of life in patients with lateral epicondylitis (tennis elbow). We want to find out if pain and mobility are improved in people who receive an injection of PRP compared to a group of people who receive an injection of whole blood, a group treated with dry needle tendon fenestration and a group of people who receive no injection.

Description:

Platelet rich plasma (PRP) deserves study because it is more expensive than the other treatments. If we learn that PRP is better compared to the other treatments, it would justify the high cost and growing industry associated with the procedure. If we find out that PRP is not better compared to the other treatments, there is the potential to save the health care system millions of dollars.

We hope to show that we can recruit eligible participants and and complete the treatment and tests to answer the questions regarding the effectiveness of platelet rich plasma for patients with tennis elbow.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: August 2018
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age - 18 years or older

• Have diagnosis of lateral epicondylitis (tennis elbow)

• Symptoms lasting at least 3 months or longer

• Have pain on a scale of 1 to 10 at level 5

(1=no pain and 10=severe pain)

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

Exclusion Criteria:

• Acute symptom onset less than 2 months

• History of acute elbow trauma less than 1 week

• History of rheumatoid arthritis

• History of malignancy

• Pregnant

• 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

• Tennis Elbow

Intervention

Biological:
• Group A Platelet Rich Plasma Injection (PRP)
Local anesthetic (lidocaine)will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a needle will then be placed into the tendon followed by 10-12 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites. Whole blood will be drawn from the patient's unaffected arm using a butterfly needle. The blood will be centrifuged and then a dose of the platelet rich plasma will be placed into the common extensor tendon.

Procedure:
• Group B Whole Blood Injection
Local anesthetic (lidocaine)will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a needle will then be placed into the tendon followed by 10-12 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites. Autologous whole blood will be drawn from the patient's unaffected arm using a butterfly needle and a portion of this blood will be placed into the common extensor tendon.
• Group C Dry Needle tendon fenestration
Local anesthetic (lidocaine)will be infiltrated into the subcutaneous tissue of the lateral elbow. Autologous whole blood will be drawn from the patient's unaffected arm, using a butterfly needle and discarded.Local anesthetic (lidocaine)will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a needle will then be placed into the tendon followed by 10-12 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.

Other:
• Group D No injection
Local anesthetic (lidocaine)will be infiltrated into the subcutaneous tissue of the lateral elbow. Autologous whole blood will be drawn from the patient's unaffected arm using a butterfly needle. 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	McMaster University Medical Center	Hamilton	Ontario
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Jon Jacobson

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as assessed by visual analog scale	The primary outcome will assess pain reduction by means of a visual analog scale at 12 months (0, no pain, maximum pain possible).	1 year
Secondary	12-item Short Form Health Survey	The short form 12 is a multidimensional measure of health-related quality of life	1 year
Secondary	Liverpool Elbow Score	Assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.	1 year
Secondary	Hospital Anxiety and Depression Scale	Tool for identifying anxiety and depression	1 year