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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01789632
First received: December 14, 2012
Last updated: June 4, 2014
Last verified: June 2014
  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 whjo receive an injection of platelet rich plasma(PRP)compared to a group of people wo receive an injection of whole blood, a group of people who receive dry needle tendon fenestration and a group of people who receive no injection.


Condition Intervention Phase
Tennis Elbow
Procedure: Group A Platelet Rich Plasma Injection (PRP)
Procedure: Group B Whole Blood Injection
Procedure: Group C Dry Needle tendon fenestration
Procedure: Group D No injection
Phase 1

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 With LateralEpicondylitis (IMPROVE): A Multicenter, Randomized Trial Comparing Autologous Whole Blood Versus 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 University of Michigan:

Primary Outcome Measures:
  • Feasibility of recruitment and adherence to protocol [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To demonstrate the feasibility of recruitment and adherence to the protocol over a 6 month recruitment period and 1 year follow-up period, which will include the following: 1) number of patients recruited during the 6 month period, 2) proportion of included patients followed at 1 year, 3) proportion of data forms completed at 1 year, 4) number of errors in randomization, 5) number of crossovers, 6)proportion of sites adhering to expertise-based randomization


Secondary Outcome Measures:
  • Assessment of pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment of reduction in pain


Other Outcome Measures:
  • Functional Disability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluation of psychological impairment as it has been shown to be increased in patients with lateral epicondylitis and has its own socioeconomic burden and symptoms related to anxiety and depression (such as decreased concentration, lack of motivation, chronic fatigue, poor sleep)will also likely influence the response to treatment.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Platelet Rich Plasma Injection (PRP)
Subjects randomized into this arm will receive an injection of Platelet Rich Plasma (PRP).
Procedure: 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, and the remaining platelet rich plasma will be sent for analysis of platelet, white blood and red blood count concentrations.
Active Comparator: Group B Whole Blood Injection
Subjects randomized into this arm will 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, and the remaining platelet rich plasma will be sent for analysis of platelet, white blood and red blood count concentrations.
Active Comparator: Group C Dry needle tendon fenestration
Subjects enrolled into this arm will receive dry needling. No blood will be injected into the tendon.
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. The superficial subcutaneous soft tissue will be re-entered however, the tendon itself will not be entered and nothing will be injected.
Active Comparator: Group D No injection
Subjects enrolled into this study will not receive any dry needling or any injection of blood into the tendon.
Procedure: 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:

Platlet rich plasma deserves study because it is more expensive than the other treatments. If we find out that platelet rich plasma 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 platelet rich plasma 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 complete the treatment and tests we plan to use to answer the questions regarding the effectiveness of platelet rich plasma for patients with tennis elbow.

  Eligibility

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

Inclusion Criteria:

  • Age - 20 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 3 months
  • History of acute elbow trauma
  • 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
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: NCT01789632

Contacts
Contact: Jon Jacobson, MD 734-936-4365 jjacobsn@umich.edu
Contact: Jeanne Hill, LPN 734-647-9546 jemhill@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jon Jacobson, MD    734-936-4365    jjacobsn@umich.edu   
Contact: Jeanne Hill, LPN    734-647-9546    jemhill@umich.edu   
Principal Investigator: jon Jacobson, MD         
Sponsors and Collaborators
Jon Jacobson
Investigators
Principal Investigator: Jon Jacobson, MD University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Jon Jacobson, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01789632     History of Changes
Other Study ID Numbers: HUM00067750
Study First Received: December 14, 2012
Last Updated: June 4, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014