B-PRPtendon: Platelet Rich Plasma (PRP) in Chronic Epicondylitis

Sponsor

Jose Ignacio Martin (Other)

Overall Status

Completed

CT.gov ID

NCT01945528

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Apr 1, 2014

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: local anesthetic

Arm

Intervention/Treatment

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 Names:

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 Names:

local anesthetic

Outcome Measures

Primary Outcome Measures

changes in the DASH-E score [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

Secondary Outcome Measures

Percentage of patients that achieve a successful treatment [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. [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 [three, six and twelve months]
frequency, severity, intensity and duration of adverse events [three, six and twelve months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Tendinopathy present in either lateral or medial elbow
Pain by palpation at the lateral or medial epicondyle of the elbow
Baseline elbow pain >3/10 during resisted wrist extension
History of at least two periods of elbow pain lasting more than 10 days
Symptoms lasting at least 3 months or longer
Body Mass Index between 20 and 35.
Commitment to comply with all study procedures
The patient must give written informed consent

Exclusion Criteria:

Presence of full tendon tear
Body mass index> 35
Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9)
Patients receiving immunosuppressive treatments
Received local steroid injection within 3 months of randomization received nonsteroidal antiinflammatory, opioids or oral corticosteroids within 15 days before inclusion in the study
Severe heart diseasePatients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
Patients with active cancer or cancer diagnosed in the last five years.
Analytical Diagnosis Hepatitis B, C or HIV infection.
Pregnant or lactating.
People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.