Clinical trial NCT01945528: Platelet Rich Plasma (PRP) in Chronic Epicondylitis
Official title: Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epicondylitis
Keywords: Platelet Rich Plasma
tendinopathy
epicondylitis
ultrasound
injection therapy
needle tenotomy
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2013-09-18
Enrollment: 86
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: changes in the DASH-E score
timeFrame: six months
Secondary outcomes:
measure: Percentage of patients that achieve a successful treatment
timeFrame: three and twelve months
measure: Pain reduction as measured by VAS.
timeFrame: three, six and twelve months
measure: changes in echogenicity and vascularity as assessed by Doppler sonography
timeFrame: three, six and twelve months
measure: frequency, severity, intensity and duration of adverse events
timeFrame: three, six and twelve months
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Cruces University Hospital/BioCruces Health Research Institute
state: Bizkaia
city: Barakaldo
country: Spain
facility: Cruces University Hospital
state: Bizkaia
Study officials:
affiliation: Cruces University Hospital, Osakidetza, Basque Health Service
name: Jose I Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andia I, Sanchez M, Maffulli N. Tendon healing and platelet-rich plasma therapies. Expert Opin Biol Ther. 2010 Oct;10(10):1415-26. doi: 10.1517/14712598.2010.514603.
citation: Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.
citation: Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Platelet-rich plasma versus lidocaine as tenotomy adjuvants in people with elbow epicondylopathy: a randomized controlled trial. J Orthop Surg Res. 2019 Apr 23;14(1):109. doi: 10.1186/s13018-019-1153-6.
citation: Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Predictors of Outcome Following Tenotomy in Patients with Recalcitrant Epicondylopathy. PM R. 2019 Sep;11(9):979-988. doi: 10.1002/pmrj.12064. Epub 2019 Mar 19.
citation: Martin JI, Merino J, Atilano L, Areizaga LM, Gomez-Fernandez MC, Burgos-Alonso N, Andia I. Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial. Trials. 2013 Dec 1;14:410. doi: 10.1186/1745-6215-14-410.