The Effect of Platelet Rich Plasma on Lateral Epicondylitis

NCT ID: NCT01851044

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-12-31

Brief Summary

The purpose of this study is to compare the effects of platelet rich plasma, whole blood and saline vehicle on the natural course of lateral epicondylitis.

Detailed Description

Lateral epicondylitis, also known as "tennis elbow", is the most common work-related disease of the upper extremity. Usually it has favorable natural healing-tendency, but sometimes it is responsible for long-lasting disability. The pathogenesis of this disease has remained unclear, however it has been speculated that the role of inflammation is smaller than previously believed. Instead, anatomical and vascular factors may play a much greater role. The evidence for the operative treatment is lacking, and the conservative treatment is therefore preferred. The conservative treatment used to rely largely on corticosteroid injections to the extensor muscle insertions. However, it has been shown that corticosteroids, in fact, tend to increase the subjective pain in the long run. Several studies -- most of them unfortunately underpowered -- have been carried out to find an efficient conservative treatment to this disease, but none of them has turned out to be significantly better than others. During the last couple of years, platelet rich plasma (PRP) has been used as a treatment in several musculoskeletal diseases (e.g. fracture healing, cartilage regeneration, wound healing). PRP is a substance centrifuged from patient own blood. There are a couple of studies regarding the use of PRP in lateral epicondylitis. The results are mostly positive; however it has not been thoroughly shown that it would be more effective than patient's whole blood. The hypothesis of this study is that PRP is more effective in the treatment of lateral epicondylitis than whole blood or saline vehicle injection. The primary outcome measures are pain (VAS) and the Disabilities of the Arm, Shoulder and Hand -score (DASH).

Conditions

Lateral Epicondylitis; Elbow Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vehicle (Saline)

2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.

Group Type: PLACEBO_COMPARATOR

Platelet Rich Plasma

Intervention Type: PROCEDURE

Whole Blood

2 ml of patient own venous blood is injected to the proximal insertion of ECRB.

Group Type: ACTIVE_COMPARATOR

Whole Blood Injection

Intervention Type: PROCEDURE

Platelet Rich Plasma

9 ml of patient own venous blood is centrifuged using The Arthrex ACP® Double Syringe System and 2 ml of platelet rich plasma is injected to the proximal insertion of ECRB.

Group Type: EXPERIMENTAL

Saline Injection

Intervention Type: PROCEDURE

Interventions

Platelet Rich Plasma

Intervention Type: PROCEDURE

Whole Blood Injection

Intervention Type: PROCEDURE

Saline Injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The duration of symptoms over 3 months
• Primary conservative treatment (physiotherapy, NSAID, ...) has been tried

Exclusion Criteria

• Significant systemic diseases
• Any surgical operation of the particular elbow

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hatanpää City Hospital, Tampere, Finland

UNKNOWN

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

Olli Leppänen

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hatanpää City Hospital

Tampere, , Finland

Countries

Finland

References

Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.

Reference Type: DERIVED

PMID: 34590307 (View on PubMed)

Other Identifiers

R11031

Identifier Type: -

Identifier Source: org_study_id