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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

December 14, 2012
June 4, 2014
January 2013
October 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01789632 on ClinicalTrials.gov Archive Site
Assessment of pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Assessment of reduction in pain
Same as current
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.
Same as current
 
Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
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.

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tennis Elbow
  • 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.
  • 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.
  • 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.
  • 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.
  • Active Comparator: Group A Platelet Rich Plasma Injection (PRP)
    Subjects randomized into this arm will receive an injection of Platelet Rich Plasma (PRP).
    Intervention: Procedure: Group A Platelet Rich Plasma Injection (PRP)
  • Active Comparator: Group B Whole Blood Injection
    Subjects randomized into this arm will receive an injection of autologous whole blood.
    Intervention: Procedure: Group B Whole Blood Injection
  • 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.
    Intervention: Procedure: Group C Dry Needle tendon fenestration
  • 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.
    Intervention: Procedure: Group D No injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2015
October 2014   (final data collection date for primary outcome measure)

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).
Both
20 Years and older
No
Contact: Jon Jacobson, MD 734-936-4365 jjacobsn@umich.edu
Contact: Jeanne Hill, LPN 734-647-9546 jemhill@umich.edu
United States
 
NCT01789632
HUM00067750
Yes
Jon Jacobson, University of Michigan
Jon Jacobson
Not Provided
Principal Investigator: Jon Jacobson, MD University of Michigan Hospital
University of Michigan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP