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Platelet Rich Plasma for Tennis Elbow (PRINT Trial)

N/A
Waitlist Available
Led By Marissa S Vasquez, MD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in symptom score between pre-study and 1 year
Awards & highlights
No Placebo-Only Group

Summary

Chronic tendinopathy is often very difficult to treat and causes many patients who suffer from it to have significant pain and loss of function leading to disability. Ultrasound has been shown to be very effective in aiding in the diagnosis of soft tissue disorders including tendinopathy and can help to rule in or out other potential causes that may be confounders. Numerous methods have been tried to treat tendinopathy including rest, NSAIDs, bracing, physical therapy, extracorporal shock wave therapy, anesthetic injections, steroid injections, prolotherapy, nitro patches, surgery and more recently platelet rich plasma, all of which have had conflicting results in the literature. Platelet rich plasma (PRP) is an autologous blood product that contains a high concentration of platelet-derived growth factors that have the potential to enhance healing. In a study by Mishra et al, common extensor tenindosis showed improved pain symptoms (71% vs 55% at 24 weeks) with tenontomy combined with PRP compared to percutaneous needle tenontomy alone. Current studies show conflicting results as to whether PRP improves chronic tendinopathy when compared to steroid injections, and many do not have any control group or comparison group. Percutaneous needle tenotomy is the use of a large gauge needle (18 gauge), which may be performed under ultrasound guidance, to fenestrate repeatedly the area of tendinopathy within a tendon in order to disrupt tendinopathic tissue and to induce bleeding and clot formation with release of growth factors. To date there are no published studies comparing percutaneous needle tenotomy (PNT) alone vs. PRP without concomitant tenotomy. Current literature suggests that needle tenotomy may be superior but no head to head studies are currently found in the literature. Most of the published literature of non-operative treatment of tendinosis does not yield clearly designed trials with clear selection criteria. Current literature also lacks studies with significant number of patients that meet both clinical and ultrasound criteria thus previous studies lack sufficient power. The PRINT TRIAL: may enhance the understanding of a superior treatment if it exists. Hypothesis: In active adults with chronic tendinopathy who have failed to respond to standard of care treatment, the use of ultrasound guided percutaneous needle tenotomy (PNT) alone is superior to PRP without concomitant tenotomy.

Eligible Conditions
  • Tennis Elbow
  • Tendonitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in symptom score between pre-study and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in symptom score between pre-study and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in DASH Symptoms Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Platelet Rich PlasmaActive Control1 Intervention
1 group will be assigned to the PRP arm. Investigators will have a trained provider draw the blood, and prepare the PRP according to manufacturer and departmental (KP) protocol. Ultrasound guided injection of this PRP using approximately an 18 gauge needle with a single pass through the tendon into affected area as demonstrated on ultrasound. Adequate amount of anesthetic will be given in a separate syringe with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of amount and type of anesthetic used. The amount of anesthesia will be the same in both arms of the study
Group II: Needle TenotomyActive Control1 Intervention
1 group will be assigned to get the standard treatment for chronic tendinopathy, percutaneous needle tenotomy (PNT). It is currently considered a standard treatment option. Ultrasound guided PNT with approximately 25 passes through the tendon and enthesis with approximately an 18 gauge needle with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,731,572 Total Patients Enrolled
1 Trials studying Tennis Elbow
42 Patients Enrolled for Tennis Elbow
Marissa S Vasquez, MDPrincipal InvestigatorKaiser Permanente
~5 spots leftby Nov 2025