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

Jose Ignacio Martin

Status and phase

Completed

Phase 3

Conditions

Epicondylitis

Treatments

Drug: US-guided tenotomy with lidocaine

Drug: US-guided tenotomy with PRP

Study type

Interventional

Funder types

Other

Identifiers

NCT01945528

2013-000478-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.