PRINT Trial (Platelet Rich Injection vs Needle Tenotomy) (PRINT)

March 12, 2019 updated by: Marissa S. Vasquez, Kaiser Permanente

PRINT Trial (Platelet Rich Injections vs. Needle Tenotomy): Evaluation of Ultrasound Guided Procedures for the Treatment of Chronic Tendinosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • KP-LAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Procedure: 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
Other Names:
  • Needle Fenestration
Active Comparator: 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
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
Other Names:
  • Platelet Rich Plasma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in DASH Symptoms Score
Time Frame: Change in symptom score between pre-study and 1 year
Disabilities of the arms, shoulder and hand symptoms questionnaire and score
Change in symptom score between pre-study and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marissa S Vasquez, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #11064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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