PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Lateral Epicondylitis, Tendinosis, Elbow, Tennis, Elbows Tendonitis

In brief

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.

Key facts

Study ID

NCT03504111

Run by

Kaiser Permanente

People needed

50

Starts

2016-07-01

Expected to finish

2019-12-31

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults: 18 years and older
• Diagnosed with: Lateral epicondylitis or common extensor tendinopathy
• Has had symptoms for more than 3 months
• Failed conservative treatment with an eccentric loading protocol that was formally taught and attempted for at least 6 weeks.
• Failed at least 1 corticosteroid injection (anatomically or ultrasound guided injection)

You may not qualify if…

• Age less than 18 years
• Pregnant or breast feeding females
• Previous surgery to the area of interest
• Previous needling procedure to the area of interest in the last 3 months
• Previous steroid injection to the area of interest in the last 3 months
• Previous PRP or autologous blood or prolotherapy to the area of interest
• Patients treated for a Workers Compensation related injury
• Any systemic disease that may play a causative role or delay in healing such as rheumatoid arthritis, lupus, immunodeficiency
• Severe degenerative bone disease or severe vascular disease that may be a confounder
• Diagnosis of concomitant nerve involvement in area of interest:
• Carpal tunnel, radial nerve impingement, cervical radiculopathy in patients with lateral epicondylitis
• Any contraindication to use of lidocaine or injections
• Will record if patient is taking any medications that may alter bleeding or clotting such as aspirin, Plavix, Coumadin, Aggrenox, heparin, lovenox, etc, but this will be a relative contraindication and decision is made by patient and provider after informed consent.

Where it is running

• KP-LAMC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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