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

Epicondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378285
• Other study ID #: ArthrexFR-001
• Secondary ID: 2009-A00804-53
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: February 26, 2015
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Arthrex SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epicondylitis

Intervention

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.

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.

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré	Boulogne

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex SAS

Country where clinical trial is conducted

France, 

References & Publications (26)

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Raeissadat SA, Sedighipour L, Rayegani SM, Bahrami MH, Bayat M, Rahimi R. Effect of Platelet-Rich Plasma (PRP) versus Autologous Whole Blood on Pain and Function Improvement in Tennis Elbow: A Randomized Clinical Trial. Pain Res Treat. 2014;2014:191525. doi: 10.1155/2014/191525. Epub 2014 Jan 20. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global pain score		1 year	No
Secondary	Roles and Maudsley score		1 year	No
Secondary	Pain on ECRB* contraction	% positive	1 year	No
Secondary	Pain on EDC** contraction	% positive	1 year	No