The Effect of Platelet Rich Plasma on Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis, Elbow Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Platelet Rich Plasma
Whole Blood Injection
Saline Injection
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Platelet Rich Plasma, Whole Blood Injection, Lateral Epicondylitis, Tennis Elbow
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
Sites / Locations
- Hatanpää City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Vehicle (Saline)
Whole Blood
Platelet Rich Plasma
Arm Description
2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
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.
Outcomes
Primary Outcome Measures
Pain (Visual Analog Scale)
Secondary Outcome Measures
Disabilities of the Arm, Shoulder and Hand -score
Full Information
NCT ID
NCT01851044
First Posted
May 5, 2013
Last Updated
October 10, 2018
Sponsor
Tampere University
Collaborators
Hatanpää City Hospital, Tampere, Finland
1. Study Identification
Unique Protocol Identification Number
NCT01851044
Brief Title
The Effect of Platelet Rich Plasma on Lateral Epicondylitis
Official Title
The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Hatanpää City Hospital, Tampere, Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Elbow Pain
Keywords
Platelet Rich Plasma, Whole Blood Injection, Lateral Epicondylitis, Tennis Elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle (Saline)
Arm Type
Placebo Comparator
Arm Description
2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
Arm Title
Whole Blood
Arm Type
Active Comparator
Arm Description
2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Plasma
Intervention Type
Procedure
Intervention Name(s)
Whole Blood Injection
Intervention Type
Procedure
Intervention Name(s)
Saline Injection
Primary Outcome Measure Information:
Title
Pain (Visual Analog Scale)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand -score
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Grip strength (Jamar)
Time Frame
52 weeks
Title
Need for non-steroidal anti-inflammatory drugs (NSAID)
Time Frame
52 weeks
Title
The duration of the potential sick leave due to lateral epicondylitis
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hatanpää City Hospital
City
Tampere
ZIP/Postal Code
33101
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34590307
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Platelet Rich Plasma on Lateral Epicondylitis
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