PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)

NCT ID: NCT03504111

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-12-31

Brief 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.

Detailed Description

The objective of our study is to determine if percutaneous needle tenontomy is superior to platelet rich plasma for the treatment of chronic tendinosis. Diagnosis of tendinosis will be confirmed utilizing ultrasound diagnostic criteria similar to past published studies. The study will be a prospective single blinded study utilizing sham phlebotomy, which currently is not found in the published literature. All interventions will be done ultrasound-guided which no studies in the published literature have done prospectively. The main variables of interest include patient outcomes such as improved function, objective clinical improvement as seen on serial ultrasound surveillance and patient reported utility. Secondary outcomes include: determine patient's ability to return to sport or activity and level of activity able to achieve using validated questionnaires. Lastly, compliance with survival curve data will also be evaluated.

Conditions

Lateral Epicondylitis; Tendinosis; Elbow, Tennis; Elbows Tendonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Needle Tenotomy

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

Group Type: ACTIVE_COMPARATOR

Percutaneous Needle Tenotomy

Intervention Type: PROCEDURE

A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided needle tenontomy with be performed at the common extensor tendon at the area of tendinosis. There will be approximately 25 passes through the tendon with an 18 gauge needle. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia

Platelet Rich Plasma

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 Type: ACTIVE_COMPARATOR

PRP

Intervention Type: PROCEDURE

A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided injection of the PRP will be performed at the common extensor tendon at the area of tendinosis. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia to the local skin

Interventions

Percutaneous Needle Tenotomy

A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided needle tenontomy with be performed at the common extensor tendon at the area of tendinosis. There will be approximately 25 passes through the tendon with an 18 gauge needle. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia

Intervention Type: PROCEDURE

PRP

A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided injection of the PRP will be performed at the common extensor tendon at the area of tendinosis. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia to the local skin

Intervention Type: PROCEDURE

Other Intervention Names

Needle Fenestration; Platelet Rich Plasma

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Marissa S. Vasquez

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marissa S Vasquez, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

KP-LAMC

Los Angeles, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

IRB #11064

Identifier Type: -

Identifier Source: org_study_id