We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789632
First Posted: February 12, 2013
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan
  Purpose
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.

Condition Intervention Phase
Tennis Elbow Biological: Group A Platelet Rich Plasma Injection (PRP) Procedure: Group B Whole Blood Injection Procedure: Group C Dry Needle tendon fenestration Other: Group D No injection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Jon Jacobson, University of Michigan:

Primary Outcome Measures:
  • Pain as assessed by visual analog scale [ Time Frame: 1 year ]
    The primary outcome will assess pain reduction by means of a visual analog scale at 12 months (0, no pain, maximum pain possible).


Secondary Outcome Measures:
  • 12-item Short Form Health Survey [ Time Frame: 1 year ]
    The short form 12 is a multidimensional measure of health-related quality of life

  • Liverpool Elbow Score [ Time Frame: 1 year ]
    Assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.

  • Hospital Anxiety and Depression Scale [ Time Frame: 1 year ]
    Tool for identifying anxiety and depression


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Platelet Rich Plasma Injection (PRP)
Subjects in this arm receive an injection of Platelet Rich Plasma (PRP).
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.
Active Comparator: Group B Whole Blood Injection
Subjects in this arm receive an injection of autologous whole blood.
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.
Active Comparator: Group C Dry needle tendon fenestration
Subjects in this arm receive dry needling.
Procedure: 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.
Active Comparator: Group D No injection
Subjects in this arm will not receive any treatment.
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789632


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Jon Jacobson
Investigators
Principal Investigator: Jon Jacobson, MD University of Michigan Hospital
  More Information

Responsible Party: Jon Jacobson, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01789632     History of Changes
Other Study ID Numbers: HUM00067750
First Submitted: December 14, 2012
First Posted: February 12, 2013
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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