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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378285
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Arthrex SAS

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Epicondylitis Device: ACP Other: Saline solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2014

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.




Primary Outcome Measures :
  1. Global pain score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Roles and Maudsley score [ Time Frame: 1 year ]
  2. Pain on ECRB* contraction [ Time Frame: 1 year ]
    % positive

  3. Pain on EDC** contraction [ Time Frame: 1 year ]
    % positive



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378285


Locations
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France
Hôpital Ambroise Paré
Boulogne, France, 92100
Sponsors and Collaborators
Arthrex SAS
Investigators
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Study Director: Philippe Hardy, Pr Hospital Ambroise Paré Paris
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arthrex SAS
ClinicalTrials.gov Identifier: NCT02378285    
Other Study ID Numbers: ArthrexFR-001
2009-A00804-53 ( Other Identifier: ANSM )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Keywords provided by Arthrex SAS:
recent lateral humeral epicondylitis
platelet-rich plasma
infiltration
tennis elbow
ultrasonography
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries