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    Summary
    EudraCT Number:2022-002717-41
    Sponsor's Protocol Code Number:TRAPEZIUS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-002717-41
    A.3Full title of the trial
    EFFICACY AND SAFETY OF LOCAL TREATMENT OF TRAPEZIUS MYOFASCIAL SYNDROME IN PATIENTS WITH FIBROMYALGIA THROUGH ULTRASOUND-GUIDED INTERFASCIAL BLOCK OF THE TRAPEZIUS MUSCLE
    EFICACIA Y SEGURIDAD DEL TRATAMIENTO LOCAL DEL SÍNDROME MIOFASCIAL DE TRAPECIO EN PACIENTES CON FIBROMIALGIA MEDIANTE EL BLOQUEO INTERFASCIAL ECOGUIADO DEL MÚSCULO TRAPECIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LOCAL INVASIVE TREATMENT OF TRAPEZIUS MUSCLE PAIN IN PATIENTS WITH FIBROMYALGIA
    TRATAMIENTO LOCAL INVASIVO DEL DOLOR MUSCULAR DE TRAPECIO EN PACIENTES CON FIBROMIALGIA
    A.3.2Name or abbreviated title of the trial where available
    TRAPEZIUS TRIAL
    ENSAYO TRAPECIO
    A.4.1Sponsor's protocol code numberTRAPEZIUS
    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 SponsorHOSPITAL CLINIC DE BARCELONA
    B.1.3.4CountrySpain
    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 supportTAMARA LIBERTAD RODRÍGUEZ ARAYA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLINIC DE BARCELONA
    B.5.2Functional name of contact pointRHEUMATOLOGY SERVICE
    B.5.3 Address:
    B.5.3.1Street AddressC/VILLARROEL, 170
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailxtorres@clinic.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 kenalog 40 mg/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharmaceuticals Unlimited Company
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Intramuscular use
    Interstitial use (Noncurrent)
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Bupivacaína Physan 2.5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLAPHYSAN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    Intramuscular use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    TRAPEZIUS MYOFASCIAL SYNDROME IN FIBROMYALGIA PATIENTS
    SÍNDROME MIOFASCIAL DE TRAPECIO EN PACIENTES CON FIBROMIALGIA
    E.1.1.1Medical condition in easily understood language
    TRAPEZIUS PAIN IN FIBROMYALGIA PATIENTS
    Dolor local de trapecio en pacientes con fibromialgia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 compare the efficacy in improving pain, both locally and generalized, in patients with fibromyalgia who present myofascial trapezius pain syndrome, as well as its duration, after regional administration of bupivacaine/triamcinolone vs physiological saline vs placebo. , in the interfascial space between the trapezius and supraspinatus muscles and between the trapezius and levator scapulae muscles.
    Comparar la eficacia en la mejoría del dolor, tanto a nivel local como generalizado, de pacientes con fibromialgia que presentan síndrome de dolor miofascial de trapecio, así como la duración de la misma, tras la administración regional de bupivacaina/triamcinolona vs suero fisiológico vs placebo, en el espacio interfascial entre los músculos trapecio y supraespinoso y entre los músculos trapecio y elevador de la escápula.
    E.2.2Secondary objectives of the trial
    1. Analyze if there are differences, before and after administration of active drug (Bupivacaine and triamcinolone), in general pain, sleep quality, mood, quality of life and functional capacity of these patients.
    2. To compare whether there is a significant difference in the effect of the active drug (chemical + mechanical action) vs physiological saline (only mechanical action) in reducing the symptoms of these patients.
    1. Analizar si existen diferencias, pre y post administración de fármaco activo (Bupivacaina y triamcinolona), en el dolor general, la calidad del sueño, estado de ánimo, la calidad de vida y capacidad funcional de estos pacientes.
    2. Comparar si hay diferencia significativa en el efecto que produce el fármaco activo (acción química + mecánica) vs suero fisiológico (acción únicamente mecánica) en la reducción de la sintomatología de estos pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients Over 18 years old
    2. Patients who suffer from Fibromyalgia, diagnosed with ACR 1990 criteria and ACR 2010 criteria.
    3. Patients who have not started a new treatment, or patients who recieve a stable treatment in the last three months.
    4. Patients who, in the last three months, have received treatment with weak opiates (tramadol or codeine), paracetamol or metamizol as rescue medication, on demand, or as prescribed.
    5. Presence of spontaneous, continuous pain in the right and/or left upper trapezius lasting more than three months, with palpable bands on examination as well as trigger points in the trapezius, with a local pain intensity scale greater than 3 , according to VAS and generalized pain scale greater than 3.
    6. Signature of the informed consent.
    1. Mayores de 18 años.
    2. Pacientes que sufren de Fibromialgia como enfermedad principal y causa de su dolor, diagnosticada con criterios de ACR 1990 y criterios ACR 2010.
    3. Pacientes que no han iniciado un tratamiento nuevo, o reciben un tratamiento estable en los últimos tres meses.
    4. Pacientes que, en los últimos tres meses, hayan recibido, como medicación de rescate, a demanda, o de forma pautada, tratamiento con opiáceos débiles (tramadol o codeína), paracetamol o metamizol.
    5. Presencia de dolor espontáneo, continuo, en el trapecio superior derecho y/o izquierdo de más de tres meses de duración, con bandas palpables a la exploración así como puntos gatillo en trapecio, con una escala de intensidad del dolor local superior a 3, según EVA y escala de dolor generalizado superior a 3.
    6. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Presence of other uncontrolled metabolic, endocrinological, cardiovascular and visceral diseases.
    2. Presence of other uncontrolled infectious, metabolic or inflammatory neuromuscular diseases.
    3. Altered coagulation and patients treated with anticoagulants.
    4. History of surgery on the cervical spine and/or shoulders.
    5. Presence of active spinal disease in the cervical and/or dorsal segments.
    6. Presence of active tendon or joint disease affecting the shoulders
    7. Intolerance, hypersensitivity or allergy to Bupivacaine or other local anesthetics.
    8. Intolerance, hypersensitivity or allergy to triamcinolone acetonide
    9. Pregnant or lactating patients.
    10. Presence of skin lesions, eczema, skin infections in the drug administration area (trapezius).
    11. Implanted electrical devices for pain management (neuromodulation).
    12. Patients who have previously undergone this type of procedure.
    13. Presence of psychiatric disorders that interfere with the adequate understanding of the treatment to be carried out or of the questionnaires (for example, psychosis or dementia).
    14. Patients who have been prescribed a new drug for their chronic pain condition or whose dose has been modified in the last three months (including antidepressants, anticonvulsants...).
    15. Patients who, in the three months prior to inclusion, have received chronic treatment with corticosteroids or strong opiates,
    16. Patients who, in the three weeks prior to inclusion, have received chronic treatment with muscle relaxants or NSAIDs.
    1. Presencia de otras enfermedades metabólicas, endocrinológicas, cardiovasculares y viscerales no controladas.
    2. Presencia de otras enfermedades neuromusculares infecciosas, metabólicas o inflamatorias no controladas.
    3. Alteración de la coagulación y pacientes en tratamiento con anticoagulantes.
    4. Antecedentes de Cirugía en columna cervical y/o hombros.
    5. Presencia de enfermedad vertebral activa en los segmentos cervical y/o dorsal.
    6. Presencia de enfermedad tendinosa o articular activa que afecte a hombros
    7. Intolerancia, hipersensibilidad o alergia a la Bupivacaina o a otros anestésicos locales.
    8. Intolerancia, hipersensibilidad o alergia a la triamcinolona acetónido
    9. Pacientes embarazadas o en periodo de lactancia.
    10. Presencia de lesiones en la piel, eccemas, infecciones dérmicas en el área de administración del fármaco (trapecios).
    11. Dispositivos eléctricos implantados para el tratamiento del dolor (neuromodulación).
    12. Pacientes sometidos a este tipo de procedimiento con anterioridad.
    13. Presencia de trastornos psiquiátricos que interfieran con la adecuada comprensión del tratamiento a realizar o de los cuestionarios (por ejemplo, psicosis o demencia).
    14. Pacientes a los que se les haya pautado un nuevo fármaco para su condición de dolor crónico o a los que se les haya modificado la dosis en los últimos tres meses (incluyendo antidepresivos, anticonvulsivantes…).
    15. Pacientes que, en los tres meses previos a la inclusión, hayan recibido tratamiento crónico con corticoterapia u opiáceos fuertes,
    16. Pacientes que, en las tres semanas previas a la inclusión, hayan recibido tratamiento crónico con relajantes musculares o AINES.
    E.5 End points
    E.5.1Primary end point(s)
    Visual Analogue Scale (VAS) of regional trapezius pain selected for treatment, at weeks 2, 4 and 12.
    Escala Analógica Visual (EVA) de dolor regional del trapecio seleccionado para tratamiento, en las semanas 2, 4 y 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, 4 and 12
    Semanas 2, 4 y 12
    E.5.2Secondary end point(s)
    - Visual Analogue Scale (VAS) of the patient's general pain
    - Visual Analog Scale (VAS) of patient fatigue
    - Sensitivity points measured by algometer with a force of 4 kg
    - WPI and SSS
    - Sleep assessment: Pittsburg Index (PSQI).
    - Functional Capacity (FIQ).
    - Quality of Life (SF-36).
    - Level of anxiety / depression (HAD).
    - Escala Analógica Visual (EVA) de dolor general del paciente
    - Escala Analógica Visual (EVA) de fatiga del paciente
    - Puntos de sensibilidad medido por algómetro con una fuerza de 4 kg
    - WPI y SSS
    - Valoración del sueño: Índice de Pittsburg (PSQI).
    - Capacidad Funcional (FIQ).
    - Calidad de Vida (SF-36).
    - Nivel de ansiedad / Depresión (HAD).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4 and 12
    Semanas 2, 4 y 12
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 No
    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
    The last visit (week twelve from infiltration) of the last subject included in the study
    La última visita (semana doce desde la infiltración) del último sujeto incluido en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 60
    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 state60
    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)
    NONE
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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