Treatment of Epicondylitis by Ultrasound-guided Local Injections of PRP (Platelet Rich Plasma)

February 26, 2015 updated by: Arthrex SAS

Treatment of Epicondylitis by Ultrasound-guided Local Injections of Autologous Conditioned Plasma (ACP®): a Double-blind Placebo-controlled Randomized Clinical Trial With One-year Follow-up

The purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective double-blind placebo-controlled randomized trial. Two ultrasound-guided injections of either PRP (ACP®, Arthrex) or saline solution were performed at 4 weeks interval.

Exclusion criterion was previous corticosteroid infiltration. All infiltrations were performed by Dr Bernard Montalvan. The selection of patients and the evaluation were conducted by Dr Patrick Le Goux who did not know which treatment had been allocated to which patient.

In the facility, no one apart from the investigators had access to full patient data.

An independent company represented by Mrs Amandine Ramseyer was hired to design, follow and carry the statistical analysis of the study. The data she got from the investigators were anonymous.

Patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months follow-up.

Secondary criteria were the Roles-Maudsley score and the assessment of pain on isometric contraction of the extensor carpi radialis brevis and of the extensor digitorum communis.

The main evaluation criterion was the relative improvement from baseline to 6 months in pain score on visual analog scale (0-10).

Intragroup and intergroup intention-to-treat analyses were performed using Student's t-tests, applying the last-observation carried forward method. Differences of proportions were tested using chi-square. The sample size calculated was 22 patients per group so that this study had a power of 90% with typeI error rate α=0.05 to demonstrate a significant greater improvement of the global pain score of at least 10%, in the PRP over the placebo group with a standard deviation of 0.10. A "p" value of less than 0.05 was considered to be statistically significant. The SPSS software (version 19 for Windows) was used to perform statistics.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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

  • France
      • Boulogne, France, 92100
        • Hopital Ambroise Pare

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from tennis elbow for less than three months
  • Patients having never received former medical or orthopedic treatment for tennis elbow

Exclusion Criteria:

  • Patients having received any treatment for this specific pathology
  • Evidence of ongoing tumoral affection (controlled by MRI)
  • Tennis elbow history
  • Elbow fracture history
  • Associated elbow pathology
  • Inflammatory rheumatic disorders
  • Bleeding disorders
  • Ongoing anticoagulation therapy
  • Allergy to local anesthetic
  • Ongoing or previous cancer affection
  • Pregnancy
  • Diabetes

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRP group
ACP infiltration: 2 mL at 0 and 4 weeks with ultrasound guidance
Device: ACP
ACP is prepared using the Autologous Conditioned Plasma (ACP®) device from Arthrex (Naples, Florida, USA), following the supplier instructions. 2 mL of ACP are transferred in a standard 2 mL injection syringe by a nurse. The standard 2 mL injection syringe is then given to the physician.The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.
Placebo Comparator: Saline solution group
Saline solution infiltration: 2mL at 0 and 4 weeks with ultrasound guidance
Other: Saline solution
2 mL of saline solution are placed in a standard injection syringe by a nurse. The syringe is then given to the physician. The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global pain score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roles and Maudsley score
Time Frame: 1 year
1 year
Pain on ECRB* contraction
Time Frame: 1 year
% positive
1 year
Pain on EDC** contraction
Time Frame: 1 year
% positive
1 year

Collaborators and Investigators

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

Sponsor

Arthrex SAS

Investigators

  • Study Director: Philippe Hardy, Pr, Hospital Ambroise Paré Paris

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

October 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArthrexFR-001
  • 2009-A00804-53 (Other Identifier: ANSM)

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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