At a glance
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Clinical and Morphological Evaluation Following Treatment of Lateral Epicondylar Tendinopathy with PRP or L-PRP,saline- Prospective Randomized Double Blinded Controlled Trial
In Brief
A clinical study evaluating effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET) for Tennis Elbow and 4 related conditions. Completed, enrolled 72 participants across 1 site.
Detailed Summary
Lateral epicondylar tendinopathy (LET), or tennis elbow, is a degenerative condition affecting the forearm's extensor tendons. It commonly leads to pain, reduced grip strength, and impaired function, particularly in individuals performing repetitive wrist and forearm movements. Standard treatments, including physiotherapy, braces, and anti-inflammatory medications, provide relief but do not always lead to full recovery. Platelet-rich plasma (PRP) has gained interest as a regenerative therapy with the potential to enhance tendon healing and improve clinical outcomes. This randomized, double-blind, placebo-controlled trial aims to evaluate PRP's effectiveness in treating LET, comparing it to leukocyte-rich PRP (L-PRP) and saline (placebo). Additionally, it assesses the composition of PRP and its role in tendon regeneration. The study will enroll 80 patients diagnosed with LET, meeting predefined clinical criteria. Participants will be randomized into three groups (PRP, L-PRP, saline) and receive two injections (day 0 and day 7). PRP will be prepared using a standardized protocol to ensure consistency. Patients will undergo clinical evaluations (VAS, Mayo Elbow Score, SECEC Elbow Score), grip strength testing, and MRI scans at baseline and 24 weeks post-treatment. The PRP composition will be analyzed in a laboratory. Follow-ups will be conducted at 12, 24, and 54 weeks to monitor pain reduction, functional improvement, and tendon healing. This study will provide critical insights into PRP's therapeutic potential, helping refine treatment approaches for LET and improve patient outcomes.
Study Details
Timeline
Interventions
The intervention involves the administration of PRP (platelet-rich plasma), L-PRP (leukocyte-rich platelet-rich plasma), and saline according to a protocol developed for patients with lateral epicondylitis (EPi lat). The intervention includes specific parameters such as centrifugation speed and dual injection to the painful site, which is repeated after one week. Following the procedure, treatment continues with a rehabilitation program, including the use of an orthosis. The orthosis serves as support during the recovery process after the injection. The rehabilitation program and the use of the orthosis aim to improve joint function and reduce pain, supporting tissue healing and regeneration.