Platelet Rich Plasma (PRP) in Chronic Epicondylitis

NCT01945528 | Completed Phase 3

• 1 other identifier: 2013-000478-32
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Epicondylitis

Keywords

Platelet Rich Plasma; tendinopathy; epicondylitis; ultrasound; injection therapy; needle tenotomy

Outcome Measures

Primary Outcomes (1)

• 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

  six months

Secondary Outcomes (4)

• Percentage of patients that achieve a successful treatment

  three and twelve months

• Pain reduction as measured by VAS.

  three, six and twelve months

• 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

Study Arms (2)

US-guided tenotomy with PRP

EXPERIMENTAL

ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions

Drug: US-guided tenotomy with PRP

US-guided tenotomy with lidocaine

ACTIVE COMPARATOR

ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions

Drug: US-guided tenotomy with lidocaine

Interventions

US-guided tenotomy with PRP DRUG

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)

US-guided tenotomy with PRP

US-guided tenotomy with lidocaine DRUG

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

US-guided tenotomy with lidocaine

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Jose Ignacio Martin: lead

Study Sites (2)

Cruces University Hospital/BioCruces Health Research Institute

Barakaldo, Bizkaia, 48903, Spain

Location

Cruces University Hospital

Barakaldo, Bizkaia, 48903, Spain

Location

Related Publications (5)

• 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.

  PMID: 20718690 BACKGROUND

• 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.

  PMID: 34590307 DERIVED

• 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.

  PMID: 31014382 DERIVED

• 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.

  PMID: 30609276 DERIVED

• 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.

  PMID: 24289799 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Lidocaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Jose I Martin, MD

  Cruces University Hospital, Osakidetza, Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jose Ignacio Martin

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 18, 2013
• Study Start: April 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

ES (2)