The Effect of Platelet Rich Plasma on Lateral Epicondylitis
The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 5, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 11, 2018
October 1, 2018
6.8 years
May 5, 2013
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain (Visual Analog Scale)
52 weeks
Secondary Outcomes (1)
Disabilities of the Arm, Shoulder and Hand -score
52 weeks
Other Outcomes (3)
Grip strength (Jamar)
52 weeks
Need for non-steroidal anti-inflammatory drugs (NSAID)
52 weeks
The duration of the potential sick leave due to lateral epicondylitis
52 weeks
Study Arms (3)
Vehicle (Saline)
PLACEBO COMPARATOR2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
Whole Blood
ACTIVE COMPARATOR2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
Platelet Rich Plasma
EXPERIMENTAL9 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.
Interventions
Eligibility Criteria
You may qualify if:
- The duration of symptoms over 3 months
- Primary conservative treatment (physiotherapy, NSAID, ...) has been tried
You may not qualify if:
- Significant systemic diseases
- Any surgical operation of the particular elbow
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere Universitylead
- Hatanpää City Hospital, Tampere, Finlandcollaborator
Study Sites (1)
Hatanpää City Hospital
Tampere, 33101, Finland
Related Publications (1)
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.
PMID: 34590307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
May 5, 2013
First Posted
May 10, 2013
Study Start
February 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
October 11, 2018
Record last verified: 2018-10