The Effect of Platelet Rich Plasma on Lateral Epicondylitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Tampere
Sponsor:
Collaborator:
Hatanpää City Hospital, Tampere, Finland
Information provided by (Responsible Party):
Olli Leppänen, University of Tampere
ClinicalTrials.gov Identifier:
NCT01851044
First received: May 5, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Lateral Epicondylitis
Elbow Pain
Procedure: Platelet Rich Plasma
Procedure: Whole Blood Injection
Procedure: Saline Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Pain (Visual Analog Scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disabilities of the Arm, Shoulder and Hand -score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Grip strength (Jamar) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Need for non-steroidal anti-inflammatory drugs (NSAID) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The duration of the potential sick leave due to lateral epicondylitis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle (Saline)
2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
Procedure: Platelet Rich Plasma
Active Comparator: Whole Blood
2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
Procedure: Whole Blood Injection
Experimental: 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.
Procedure: Saline Injection

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851044

Contacts
Contact: Olli V Leppänen, M.D., Ph.D. +358-40-5866581 olli.v.leppanen@uta.fi
Contact: Janne Lehtinen, M.D., Ph.D. janne.lehtinen@tampere.fi

Locations
Finland
Hatanpää City Hospital Recruiting
Tampere, Finland, 33101
Contact: Janne Lehtinen, M.D., Ph.D.       janne.lehtinen@tampere.fi   
Principal Investigator: Olli V. Leppänen, M.D., Ph.D.         
Principal Investigator: Janne Lehtinen, M.D., Ph.D.         
Sub-Investigator: Niina Ruopsa, M.D.         
Sub-Investigator: Tuula Salmi, M.D.         
Sponsors and Collaborators
University of Tampere
Hatanpää City Hospital, Tampere, Finland
  More Information

No publications provided

Responsible Party: Olli Leppänen, Researcher, University of Tampere
ClinicalTrials.gov Identifier: NCT01851044     History of Changes
Other Study ID Numbers: R11031
Study First Received: May 5, 2013
Last Updated: May 7, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Tampere:
Platelet Rich Plasma
Whole Blood Injection
Lateral Epicondylitis
Tennis Elbow

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014