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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Jose Ignacio Martin, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01945528
First received: September 16, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Epicondylitis
Drug: US-guided tenotomy with PRP
Drug: US-guided tenotomy with lidocaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • changes in the DASH-E score [ Time Frame: six months ] [ Designated as safety issue: No ]
    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 [ Time Frame: three and twelve months ] [ Designated as safety issue: No ]
    successful treatment defined as a reduction of greater than 25% of the DASH-E score

  • Pain reduction as measured by VAS. [ Time Frame: three, six and twelve months ] [ Designated as safety issue: No ]
    changes in pain rating on a visual analogue scale (VAS)with respect to baseline

  • changes in echogenicity and vascularity as assessed by Doppler sonography [ Time Frame: three, six and twelve months ] [ Designated as safety issue: No ]
  • frequency, severity, intensity and duration of adverse events [ Time Frame: three, six and twelve months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: local anesthetic

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945528

Contacts
Contact: Isabel Andia, PhD 946006000 ext 2434 isabel.andiaortiz@osakidetza.net
Contact: Natalia Burgos, PhD 946006637 natalia.burgosalonso@osakidetza.net

Locations
Spain
Cruces University Hospital/BioCruces Health Research Institute Not yet recruiting
Barakaldo, Bizkaia, Spain, 48903
Contact: Isabel Andia, PhD    +34 946006000 ext 2434    isabel.andiaortiz@osakidetza.net   
Contact: Natalia Burgos, PhD    +34 946006000 ext 6637    natalia.burgosalonso@osakidetza.net   
Principal Investigator: Jose I Martin, MD         
Sub-Investigator: Josu Merino, MD         
Sub-Investigator: Luis Areizaga, MD         
Sub-Investigator: Leire Atilano, MD         
Sub-Investigator: Isabel Andia, PhD         
Sub-Investigator: Gotzon Iglesias, MD         
Sub-Investigator: Igor Gonzalez, MD         
Cruces University Hospital Recruiting
Barakaldo, Bizkaia, Spain, 48903
Contact: Isabel Andia, PhD    +34 946006000 ext 2434    isabel.andiaortiz@osakidetza.net   
Sponsors and Collaborators
Jose Ignacio Martin
Investigators
Principal Investigator: Jose I Martin, MD Cruces University Hospital, Osakidetza, Basque Health Service
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Ignacio Martin, Basque Health Service
ClinicalTrials.gov Identifier: NCT01945528     History of Changes
Other Study ID Numbers: 2013-000478-32, 2013-000478-32
Study First Received: September 16, 2013
Last Updated: July 16, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Basque Health Service:
Platelet Rich Plasma
tendinopathy
epicondylitis
ultrasound
injection therapy
needle tenotomy

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014