Platelet Rich Plasma (PRP) in Chronic Epicondylitis (B-PRPtendon)
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|ClinicalTrials.gov Identifier: NCT01945528|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2013
Last Update Posted : September 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Epicondylitis||Drug: US-guided tenotomy with PRP Drug: US-guided tenotomy with lidocaine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: US-guided tenotomy with PRP
ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions
Drug: US-guided tenotomy with PRP
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
Other Name: pure-PRP (without leukocytes)
Active Comparator: US-guided tenotomy with lidocaine
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. 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
Other Name: local anesthetic
- changes in the DASH-E score [ Time Frame: six months ]percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline
- Percentage of patients that achieve a successful treatment [ Time Frame: three and twelve months ]successful treatment defined as a reduction of greater than 25% of the DASH-E score
- Pain reduction as measured by VAS. [ Time Frame: three, six and twelve months ]changes in pain rating on a visual analogue scale (VAS)with respect to baseline
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945528
|Cruces University Hospital/BioCruces Health Research Institute|
|Barakaldo, Bizkaia, Spain, 48903|
|Cruces University Hospital|
|Barakaldo, Bizkaia, Spain, 48903|
|Principal Investigator:||Jose I Martin, MD||Cruces University Hospital, Osakidetza, Basque Health Service|