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

Primary Purpose

Epicondylitis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
US-guided tenotomy with PRP
US-guided tenotomy with lidocaine
Sponsored by
Jose Ignacio Martin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring Platelet Rich Plasma, tendinopathy, epicondylitis, ultrasound, injection therapy, needle tenotomy

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cruces University Hospital/BioCruces Health Research Institute
  • Cruces University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

US-guided tenotomy with PRP

US-guided tenotomy with lidocaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients that achieve a successful treatment
successful treatment defined as a reduction of greater than 25% of the DASH-E score
Pain reduction as measured by VAS.
changes in pain rating on a visual analogue scale (VAS)with respect to baseline
changes in echogenicity and vascularity as assessed by Doppler sonography
frequency, severity, intensity and duration of adverse events

Full Information

First Posted
September 16, 2013
Last Updated
January 15, 2019
Sponsor
Jose Ignacio Martin
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1. Study Identification

Unique Protocol Identification Number
NCT01945528
Brief Title
Platelet Rich Plasma (PRP) in Chronic Epicondylitis
Acronym
B-PRPtendon
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Ignacio Martin

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis
Keywords
Platelet Rich Plasma, tendinopathy, epicondylitis, ultrasound, injection therapy, needle tenotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-guided tenotomy with PRP
Arm Type
Experimental
Arm Description
ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions
Arm Title
US-guided tenotomy with lidocaine
Arm Type
Active Comparator
Arm Description
ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions
Intervention Type
Drug
Intervention Name(s)
US-guided tenotomy with PRP
Other Intervention Name(s)
pure-PRP (without leukocytes)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
US-guided tenotomy with lidocaine
Other Intervention Name(s)
local anesthetic
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in the DASH-E score
Description
percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline
Time Frame
six months
Secondary Outcome Measure Information:
Title
Percentage of patients that achieve a successful treatment
Description
successful treatment defined as a reduction of greater than 25% of the DASH-E score
Time Frame
three and twelve months
Title
Pain reduction as measured by VAS.
Description
changes in pain rating on a visual analogue scale (VAS)with respect to baseline
Time Frame
three, six and twelve months
Title
changes in echogenicity and vascularity as assessed by Doppler sonography
Time Frame
three, six and twelve months
Title
frequency, severity, intensity and duration of adverse events
Time Frame
three, six and twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose I Martin, MD
Organizational Affiliation
Cruces University Hospital, Osakidetza, Basque Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cruces University Hospital/BioCruces Health Research Institute
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Cruces University Hospital
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20718690
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.
Results Reference
background
PubMed Identifier
34590307
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.
Results Reference
derived
PubMed Identifier
31014382
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.
Results Reference
derived
PubMed Identifier
30609276
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.
Results Reference
derived
PubMed Identifier
24289799
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.
Results Reference
derived

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Platelet Rich Plasma (PRP) in Chronic Epicondylitis

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