Epicondylitis Clinical Trial
Official title:
Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis
Background Tendinopathy is a difficult problem to manage and can result in significant
patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but
its efficacy remains controversial. Current experimental research postulates different
efficiency among PRP formulations.Recent reviews showed that most clinical studies in
tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy
of pure-PRP in the management of epicondylitis.
The investigators hypothesized that pure PRP associated to needling intervention can enhance
tendon healing in epicondylitis, improve function and reduce pain.
Methods and design Randomized double blind controlled trial, a total of 80 patients will be
randomly allocated into one of two groups: PRP or control. Interventions: PRP group,
ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate
week for a total of two interventions. Control Group: US-guided needling with lidocaine each
alternate week for a total of two interventions. Main outcome measure: Changes in pain and
activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome
measure score, before and six months after intervention.The primary end-point is 25%
reduction in DASH. The investigators will compare the percentage of patients, in each group,
that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.
Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in
pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up.
Changes in sonographic features and neovascularity at 3, 6 and 12 months.
n/a
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