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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by McMaster University
Sponsor:
Collaborators:
Arthrex, Inc.
The Physicians' Services Incorporated Foundation
Radiological Society of North America
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01668953
First received: August 16, 2012
Last updated: April 20, 2014
Last verified: April 2014
  Purpose

"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 Intervention
Lateral Epicondylitis (Tennis Elbow)
Other: Platelet Rich Plasma (PRP) Injection
Other: Whole Blood Injection
Other: Dry Needle Fenestration
Other: Sham Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Pain Reduction [ Time Frame: Baseline, 6 weeks, 3, 6, 12 months ] [ Designated as safety issue: No ]
    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:
  • Functional Disability [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Psychological Impairment [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Health-Related Quality of Life [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  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.
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
  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.
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
  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.
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
  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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult man or woman aged 20 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668953

Contacts
Contact: Mary M Chiavaras, MD, PhD 905-521-2100 ext 46521 meg.chiavaras@gmail.com

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5326
Contact: Jon Jacobson, MD       jjacobsn@umich.edu   
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Nicole Simunovic, MSc    905-527-4322 ext 44695    simunon@mcmaster.ca   
Principal Investigator: Mary M Chiavaras, MD, PhD         
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

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01668953     History of Changes
Other Study ID Numbers: IMPROVE-001, Research Seed Grant # 1204
Study First Received: August 16, 2012
Last Updated: April 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Lateral Epicondylitis
Tennis Elbow
Platelet Rich Plasma
Whole Blood
Tendon Fenestration

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 11, 2014