A Phase 3 interventional study of US-guided tenotomy with PRP and US-guided tenotomy with lidocaine in Epicondylitis, sponsored by Jose Ignacio Martin. Completed at 2 sites in Spain. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Jose Ignacio Martin · Phase 3, Interventional, and Treatment
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.
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's enrollment of 86 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.
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Exclusion Criteria:
ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions
Drug: US-guided tenotomy with PRP
ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions
Drug: US-guided tenotomy with lidocaine
Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure
Also known as: pure-PRP (without leukocytes)
Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure
Also known as: local anesthetic
changes in the DASH-E score
percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline
Time frame: six months
Percentage of patients that achieve a successful treatment
successful treatment defined as a reduction of greater than 25% of the DASH-E score
Time frame: three and twelve months
Pain reduction as measured by VAS.
changes in pain rating on a visual analogue scale (VAS)with respect to baseline
Time frame: three, six and twelve months
changes in echogenicity and vascularity as assessed by Doppler sonography
Time frame: three, six and twelve months
frequency, severity, intensity and duration of adverse events
Time frame: three, six and twelve months
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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