Platelet Rich Plasma (PRP) in Chronic Epicondylitis (B-PRPtendon)

January 15, 2019 updated by: Jose Ignacio Martin

Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis

Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but its efficacy remains controversial. Current experimental research postulates different efficiency among PRP formulations.Recent reviews showed that most clinical studies in tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy of pure-PRP in the management of epicondylitis.

The investigators hypothesized that pure PRP associated to needling intervention can enhance tendon healing in epicondylitis, improve function and reduce pain.

Methods and design Randomized double blind controlled trial, a total of 80 patients will be randomly allocated into one of two groups: PRP or control. Interventions: PRP group, ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate week for a total of two interventions. Control Group: US-guided needling with lidocaine each alternate week for a total of two interventions. Main outcome measure: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome measure score, before and six months after intervention.The primary end-point is 25% reduction in DASH. The investigators will compare the percentage of patients, in each group, that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.

Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up. Changes in sonographic features and neovascularity at 3, 6 and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

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

  • Spain
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Cruces University Hospital
      • Barakaldo, Bizkaia, Spain, 48903
        • Cruces University Hospital/BioCruces Health Research Institute

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

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Tendinopathy present in either lateral or medial elbow
  • Pain by palpation at the lateral or medial epicondyle of the elbow
  • Baseline elbow pain >3/10 during resisted wrist extension
  • History of at least two periods of elbow pain lasting more than 10 days
  • Symptoms lasting at least 3 months or longer
  • Body Mass Index between 20 and 35.
  • Commitment to comply with all study procedures
  • The patient must give written informed consent

Exclusion Criteria:

  • Presence of full tendon tear
  • Body mass index> 35
  • Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
  • Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
  • Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9)
  • Patients receiving immunosuppressive treatments
  • Received local steroid injection within 3 months of randomization received nonsteroidal antiinflammatory, opioids or oral corticosteroids within 15 days before inclusion in the study
  • Severe heart diseasePatients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
  • Patients with active cancer or cancer diagnosed in the last five years.
  • Analytical Diagnosis Hepatitis B, C or HIV infection.
  • Pregnant or lactating.
  • People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: US-guided tenotomy with PRP
ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions
Drug: US-guided tenotomy with PRP

Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected.

Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure

Other Names:
  • pure-PRP (without leukocytes)
ACTIVE_COMPARATOR: US-guided tenotomy with lidocaine
ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions
Drug: US-guided tenotomy with lidocaine
Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure
Other Names:
  • local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in the DASH-E score
Time Frame: six months
percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients that achieve a successful treatment
Time Frame: three and twelve months
successful treatment defined as a reduction of greater than 25% of the DASH-E score
three and twelve months
Pain reduction as measured by VAS.
Time Frame: three, six and twelve months
changes in pain rating on a visual analogue scale (VAS)with respect to baseline
three, six and twelve months
changes in echogenicity and vascularity as assessed by Doppler sonography
Time Frame: three, six and twelve months
three, six and twelve months
frequency, severity, intensity and duration of adverse events
Time Frame: three, six and twelve months
three, six and twelve months

Collaborators and Investigators

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

Sponsor

Jose Ignacio Martin

Investigators

  • Principal Investigator: Jose I Martin, MD, Cruces University Hospital, Osakidetza, Basque Health Service

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

April 1, 2014

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (ESTIMATE)

September 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-000478-32 (EUDRACT_NUMBER)

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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