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Completed

NCT Number: NCT01945528

Platelet Rich Plasma (PRP) in Chronic Epicondylitis

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.

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Key information

Conditions

Epicondylitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cruces University Hospital, Barakaldo, Bizkaia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: pure-PRP (without leukocytes)

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

Other names: local anesthetic

Primary outcomes

  1. changes in the DASH-E score

    Time frame: six months

    percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline

Secondary outcomes

  1. Percentage of patients that achieve a successful treatment

    Time frame: three and twelve months

    successful treatment defined as a reduction of greater than 25% of the DASH-E score

  2. Pain reduction as measured by VAS.

    Time frame: three, six and twelve months

    changes in pain rating on a visual analogue scale (VAS)with respect to baseline

  3. changes in echogenicity and vascularity as assessed by Doppler sonography

    Time frame: three, six and twelve months

  4. frequency, severity, intensity and duration of adverse events

    Time frame: three, six and twelve months

Sponsors and collaborators

Lead sponsor

Jose Ignacio Martin

Other Gov

Registry information

Official study title

Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis

Acronym: B-PRPtendon

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2013
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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