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

NCT02378285 | Completed

• 2 other identifiers: ArthrexFR-0012009-A00804-53
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Epicondylitis

Keywords

recent lateral humeral epicondylitis; platelet-rich plasma; infiltration; tennis elbow; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Global pain score

  1 year

Secondary Outcomes (3)

• Roles and Maudsley score

  1 year

• Pain on ECRB* contraction

  1 year

• Pain on EDC** contraction

  1 year

Study Arms (2)

PRP group

ACTIVE COMPARATOR

ACP infiltration: 2 mL at 0 and 4 weeks with ultrasound guidance

Device: ACP

Saline solution group

PLACEBO COMPARATOR

Saline solution infiltration: 2mL at 0 and 4 weeks with ultrasound guidance

Other: Saline solution

Interventions

ACP DEVICE

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.

PRP group

Saline solution OTHER

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.

Saline solution group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrex SAS: lead

Study Sites (1)

Hôpital Ambroise Paré

Boulogne, 92100, France

Location

Related Publications (27)

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MeSH Terms

Conditions

Tennis Elbow

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Philippe Hardy, Pr

  Hospital Ambroise Paré Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 4, 2015
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 4, 2015

Record last verified: 2015-02

Locations

FR (1)