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

Sponsor

Arthrex SAS (Industry)

Overall Status

Completed

CT.gov ID

NCT02378285

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Global pain score [1 year]

Secondary Outcome Measures

Roles and Maudsley score [1 year]
Pain on ECRB* contraction [1 year]
% positive
Pain on EDC** contraction [1 year]
% positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Ambroise Paré	Boulogne		France	92100

Sponsors and Collaborators

Arthrex SAS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Arthrex SAS

ClinicalTrials.gov Identifier:

NCT02378285

Other Study ID Numbers:

ArthrexFR-001
2009-A00804-53

First Posted:

Mar 4, 2015

Last Update Posted:

Mar 4, 2015

Last Verified:

Feb 1, 2015

Keywords provided by Arthrex SAS

recent lateral humeral epicondylitis

Additional relevant MeSH terms:

Tennis Elbow

Study Results

No Results Posted as of Mar 4, 2015