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

Primary Purpose

Lateral Epicondylitis, Tendinosis, Elbow, Tennis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Needle Tenotomy
PRP
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • KP-LAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Needle Tenotomy

Platelet Rich Plasma

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in DASH Symptoms Score
Disabilities of the arms, shoulder and hand symptoms questionnaire and score

Secondary Outcome Measures

Full Information

First Posted
March 30, 2017
Last Updated
March 12, 2019
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT03504111
Brief Title
PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)
Acronym
PRINT
Official Title
PRINT Trial (Platelet Rich Injections vs. Needle Tenotomy): Evaluation of Ultrasound Guided Procedures for the Treatment of Chronic Tendinosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tendinosis, Elbow, Tennis, Elbows Tendonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Needle Tenotomy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Platelet Rich Plasma
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Needle Tenotomy
Other Intervention Name(s)
Needle Fenestration
Intervention Description
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
Intervention Name(s)
PRP
Other Intervention Name(s)
Platelet Rich Plasma
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in DASH Symptoms Score
Description
Disabilities of the arms, shoulder and hand symptoms questionnaire and score
Time Frame
Change in symptom score between pre-study and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa S Vasquez, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
KP-LAMC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24932444
Citation
Abate M, Verna S, Di Gregorio P, Salini V, Schiavone C. Sonographic findings during and after Platelet Rich Plasma injections in tendons. Muscles Ligaments Tendons J. 2014 May 8;4(1):29-34. eCollection 2014 Jan.
Results Reference
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Citation
Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26.
Results Reference
background
PubMed Identifier
16735582
Citation
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
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23487340
Citation
Chiavaras MM, Jacobson JA. Ultrasound-guided tendon fenestration. Semin Musculoskelet Radiol. 2013 Feb;17(1):85-90. doi: 10.1055/s-0033-1333942. Epub 2013 Mar 13.
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Citation
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PubMed Identifier
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Citation
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Citation
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derived

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PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)

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