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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01789632
First received: December 14, 2012
Last updated: February 20, 2017
Last verified: February 2017
December 14, 2012
February 20, 2017
January 2013
December 2017   (Final data collection date for primary outcome measure)
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).
Feasibility of recruitment and adherence to protocol [ Time Frame: 1 year ]
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
Complete list of historical versions of study NCT01789632 on ClinicalTrials.gov Archive Site
  • 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
Assessment of pain [ Time Frame: 1 year ]
Assessment of reduction in pain
Not Provided
Functional Disability [ Time Frame: 1 year ]
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.
 
Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
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.
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Tennis Elbow
  • 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.
  • 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.
  • 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.
  • Active Comparator: Group A Platelet Rich Plasma Injection (PRP)
    Subjects in this arm receive an injection of Platelet Rich Plasma (PRP).
    Intervention: Biological: Group A Platelet Rich Plasma Injection (PRP)
  • Active Comparator: Group B Whole Blood Injection
    Subjects in this arm receive an injection of autologous whole blood.
    Intervention: Procedure: Group B Whole Blood Injection
  • Active Comparator: Group C Dry needle tendon fenestration
    Subjects in this arm receive dry needling.
    Intervention: Procedure: Group C Dry Needle tendon fenestration
  • Active Comparator: Group D No injection
    Subjects in this arm will not receive any treatment.
    Intervention: Other: 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.
 
Active, not recruiting
20
June 2018
December 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01789632
HUM00067750
Yes
Not Provided
Plan to Share IPD: No
Jon Jacobson, University of Michigan
Jon Jacobson
Not Provided
Principal Investigator: Jon Jacobson, MD University of Michigan Hospital
University of Michigan
February 2017

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