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    Summary
    EudraCT Number:2018-002822-22
    Sponsor's Protocol Code Number:NL66032.091.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002822-22
    A.3Full title of the trial
    US-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial
    Echografisch-geleide percutane naald tenotomie bij patiënten met laterale elleboogtendinopathie: een multicenter gerandomiseerd onderzoek met controlegroep
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Needling in patients with tennis elbow
    Needling in patiënten met een tenniselleboog
    A.3.2Name or abbreviated title of the trial where available
    PUNT
    PUNT
    A.4.1Sponsor's protocol code numberNL66032.091.18
    A.5.4Other Identifiers
    Name:Nederlands TrialregisterNumber:7223
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSint Maartenskliniek
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSint Maartenskliniek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek
    B.5.2Functional name of contact pointSenior researcher
    B.5.3 Address:
    B.5.3.1Street AddressHengstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574 NA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003102436272731
    B.5.6E-mailk.smulders@maartenskliniek.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lidocainehydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameLidocaine
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lateral Elbow Tendinopathy is a common cause for chronic pain in the elbow, where the pain is present for longer than 6 months. Currently, the rationale is that the tendinopathy is the result of the repetitive strain of the hand, wrist and elbow.
    Laterale elleboogtendinopathie (LET) is een veel voorkomende oorzaak van chronische pijn in de elleboog, waarbij de pijn langer dan 6 maanden aanwezig is. Tegenwoordig is de rationale dat de tendinopathie het resultaat is van herhalende belasting van de hand, pols en elleboog, echter het kan ook worden geïnitieerd door een acuut trauma.
    E.1.1.1Medical condition in easily understood language
    Tennis elbow
    Tenniselleboog
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of Percutaneous Needle Tenotomy (PNT) and structured exercise on function and pain of patients with Lateral Elbow Tendinopathy (LET).
    Het effect van Percutane Naald Tenotomie (PNT) en gestructureerde oefeningen op functie en pijn van patiënten met laterale elleboogtendinopathie te bestuderen.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 18 and 65 years
    • Pain in the elbow present for more than 12 months, unresponsive to conservative treatment
    • Sonographically proven tendinopathy (hypervascularisation, deep tendon calcifications, hypoechogenic tendon, erosive cortex)
    • Concordant pain during compression with a US Probe in the region of the extensor tendons
    • Is able to give informed consent
    • Is instructable to follow the exercises
    • Leeftijd 18-65 jaar
    • Pijn in de elleboog langer dan 12 maanden, niet reagerend op conservatieve behandeling
    • Echografisch bewezen tendinopathie (hypervasculansatie, diepe pees calcificaties, hypoechogene pees, erosieve cortex)
    • Concordante pijn tijdens compressie met de echo transducer in de regio van de extensor pezen
    • Is in staat informed consent te geven
    • Is te instrueren om de oefeningen te volgen
    E.4Principal exclusion criteria
    • Surgery related to the lateral elbow tendinopathy, including Needle Aspiration of Calcific Deposits (NACD)
    • Systemic joint disease such as rheumatoid arthritis etc.
    • Rupture or clefts >1cm of the extensor tendons
    • Detachment of extensor tendons or tears in collateral ligament
    • Contraindication for lidocaïne in accordance to the SPC
    • Pregnancy
    • Use of anti-inflammatory drugs, such as NSAIDs, steroids, methotrexate, anti-TNF, azathioprine
    • Use of anticoagulant drugs which is bridged with acetylsalicylate acid
    • Physical, emotional or neurological conditions that would compromise the patient’s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple Sclerosis, etc.)
    • Chirurgie gerelateerd aan de laterale elleboogtendinopathie, inclusief barbotage
    • Systemische gewrichtsziekte (R.A. etc.)
    • Ruptuur of kloven > 1cm van de extensorpezen
    • Contra-indicatie voor lidocaïne volgens SPC
    • Zwangerschap
    • Gebruik ontstekingsremmende medicijnen, zoals NSAID's, corticostereoiden, methotrexaat, anti-TNF en azathioprine
    • Gebruik anticoagulantia dat gebridged wordt met acetylsalicylzuur
    • Fysieke, emotionele of neurologische aandoeningen die de compliantie van de patiënt aan het postoperatief revalidatieprotocol beïnvloeden (bijv.: drugs of alcohol abusus, ernstige psychische ziekte, of algemene neurologische aandoeningen zoals Parkinson, Multiple Sclerosis, etc.)
    E.5 End points
    E.5.1Primary end point(s)
    The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a patient reported outcome measure (PROM) specifically developed for lateral elbow tendinopathy.
    De "Patient-Rated Tennis Elbow Evaluation" (PRTEE) is een patiënt reported outcome measure (PROM) specifiek ontwikkeld voor laterale elleboogtendinopathie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three months after start intervention
    Drie maanden na start interventie
    E.5.2Secondary end point(s)
    • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Outcome Measure - a questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
    • EQ-5D - a standardized instrument for use as a measure of health outcome
    • Two questions concerning patiënt satisfaction
    • Questionnaire concerning adherence to and possible diffuculties with the structured exercise schedule
    • Pain measured using the numerical rating scale (NRS)
    • "Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure" - PROM ontworpen om fysieke functie en symptomen van patiënten met musculoskeletale aandoeningen van bovenste ledemaat te meten
    • EQ-5D -gestandaardiseerd instrument voor het gebruik als maat voor gezondheid uitkomst
    • Twee vragen over patiënt tevredenheid
    • Vragenlijst over het opvolgen van de gestructureerde oefeningen thuis
    • Pijn - gemeten met de numerical rating scale (NRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months after start intervention
    Drie maanden na start interventie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Hoofdinterventie: PNT + oefeningen. Controls: 1 Lokale verdoving + oefeningen. 2 Alleen oefeningen
    Main intervention: PNT + exercises. Comparators: 1 Local anaesthesia + excercises. 2 Only excercises
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 114
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 114
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    In case the patients still suffer from complains of their elbow after three months, they can receive the PNT post trial.
    Indien de patiënten na drie maanden nog steeds klachten hebben van hun elleboog kunnen ze alsnog de PNT ontvangen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical University Innsbruck
    G.4.3.4Network Country Austria
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Medical University Antwerpen
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Independent Radiology Practice Heraklion
    G.4.3.4Network Country Greece
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation The Rizzoli Orthopaedic Institute
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation University of Genova
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Centro Hospitalar Universitário do Algarve
    G.4.3.4Network Country Portugal
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation University Hospital Basurto
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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