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Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial
Jose I Martin1, Josu Merino, Leire Atilano
1Regenerative Medicine Laboratory, BioCruces Health Research Institute, Hospital Universitario Cruces, Pza Cruces s/n, Barakaldo 48903, Spain. iandia2010@hotmail.com.
Trials
|December 3, 2013
Summary
This study investigates if pure platelet-rich plasma (PRP) injections improve painful tendon conditions more than lidocaine. Results will clarify PRP efficacy for tendinopathy treatment.
Area of Science:
- Orthopedics
- Regenerative Medicine
- Musculoskeletal Disorders
Background:
- Tendinopathy presents management challenges and significant patient morbidity.
- Platelet-rich plasma (PRP) is widely used for painful tendons, but its effectiveness is debated.
- ClinicalTrials.gov identifier: NCT01945528.
Purpose of the Study:
- To evaluate the efficacy of ultrasound-guided, leukocyte-depleted (pure) PRP compared to lidocaine for treating painful tendinopathy.
- To determine optimal protocols for PRP application in tendinopathies.
Main Methods:
- A single-center, randomized, double-blind controlled trial involving 80 patients.
- Participants received two interventions of either pure PRP or lidocaine, guided by ultrasound, on alternate weeks.
- Outcome data collected at baseline and 6 weeks, 3, 6, and 12 months post-intervention.
Main Results:
- Primary outcome: Percentage of patients achieving at least a 25% reduction in the Disabilities of the Arm, Shoulder and Hand (DASH-E) score at 6 months.
- Secondary outcomes: Changes in DASH-E scores at 3 and 12 months, Visual Analogue Scale (VAS) pain scores, sonographic features, neovascularity, and adverse reactions.
Conclusions:
- The study aims to provide insights into the effectiveness of pure PRP for tendon conditions.
- Findings may help establish best practices for PRP therapy in tendinopathies.
