E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
lower extremity radicular pain |
Dolor radicular extremidad inferior |
|
E.1.1.1 | Medical condition in easily understood language |
lower extremity radicular pain |
Dolor por ciatalgia en pierna |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess whether therapy with conditioned autologous serum on the dorsal root ganglion reduces neuropathic pain in patients with persistent lower limb radiculalgia |
Evaluar si la terapia con Suero autólogo condicionado sobre el ganglio de la raiz dorsal reduce el dolor neuropático de los pacientes con radiculalgia persistente de miembro inferior |
|
E.2.2 | Secondary objectives of the trial |
Assess the degree of improvement of neuropathic pain and its symptoms Evaluate the functionality of these patients at 30 days, at 3 months and at 6 months, at 12 months. To assess the quality of life of these patients at 30 days, 3 months, 6 months and 12 months. Assess the mood of these patients at 30 days, 3 months, 6 months and 12 months. |
Evaluar el grado de mejoría de dolor neuropático y sus síntomas Evaluar la funcionalidad de estos pacientes a los 30 días, a los 3 meses y a los 6 meses, a los 12 meses. Evaluar la calidad de vida de estos pacientes a los 30 días, a los 3 meses, a los 6 meses y a los 12 meses. Evaluar el estado anímico de estos pacientes a los 30 días, a los 3 meses, a los 6 meses y a los 12 meses. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years, not illiterate, with lower limb radicular pain of more than 6 months. Inclusion criteria: Unilateral, mono and / or bisegmental radicular pain of a lower limb lasting at least more than 6 months. In case of having received treatment previously, at least 3 months must have passed since the last therapy received (infiltration, radiofrequency or surgery) and the pain persist in the same territory. Present lumbar Nuclear Magnetic Resonance (NMR), Electromyography (EMG) done concomitantly to the pain that the patient presents at the time of inclusion in the study.
Present a score greater than 5 in the DN4 questionnaire at the time of inclusion in the study. |
Pacientes mayores de 18 años, no analfabetos, con dolor radicular de miembro inferior de más de 6 meses. Criterios de inclusión: Dolor radicular unilateral, mono y/o bisegmentario de una extremidad inferior de al menos más de 6 meses de duración. En caso de haber recibido tratamiento con anterioridad, debe haber pasado al menos 3 meses desde la última terapia recibida (infiltración, radiofrecuencia o cirugía) y persistir el dolor en el mismo territorio. Presentar Resonancia Magnética Nuclear (RMN) lumbar, Electromiografia (EMG) hechas concomitantemente al dolor que presenta el paciente en el momento de inclusión en el estudio.
Presentar una puntuación mayor de 5 en el cuestionario de DN4 en el momento de inclusión en el estudio. |
|
E.4 | Principal exclusion criteria |
exclusion criteria: Refusal of the patient to participate in the study or not to sign the informed consent Allergy to intravenous iodinated contrast and / or local anesthetics. Impossibility of the patient to maintain the prone position. Systemic or local infection at the puncture site. Present any of the following symptoms: atypical radiation pattern, bilateral involvement, involvement of more than two segments or roots. Concomitant pathological history during study / therapy: oncological disease, vertebral fractures, myelopathy, systemic disease, connective tissue disease, coagulation disorder, multiple sclerosis, osteomyelitis, or bone edema. Pregnancy or breastfeeding Previous treatment with spinal neurostimulator placement Previous treatment with brain stimulator for treatment of epilepsy or Parkinson's disease. Cardiac pacemaker carrier. Patient who does not attend any of the treatment sessions for unjustified reasons. |
Criterios de exclusión: Negativa del paciente a participar en el estudio o no firmar el consentimiento informado Alergia al contraste iodado endovenoso y/o a los anestésicos locales. Imposibilidad del paciente de mantener la posición de decúbito prono. Infección sistémica o local en el punto de punción. Presentar alguno de los siguientes síntomas: patrón de radiación atípico, afectación bilateral, afectación de más de dos segmentos o raíces. Historia clínica patológica concomitante durante el estudio/terapia: enfermedad oncológica, fracturas vertebrales, mielopatia, enfermedad sistémica, conectivopatía, alteración de la coagulación, esclerosis múltiple, osteomielitis, o edema óseo. Embarazo o lactancia Tratamiento previo con colocación de Neuroestimulador medular Tratamiento previo con estimulador cerebral para tratamiento de epilepsia o enfermedad de parkinson. Portador de marcapasos cardíaco. Paciente que no acuda a alguna de las sesiones de tratamiento por motivo no justificado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pain improvement of at least 20% |
Mejoría del Dolor de almenos un 20% |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after therapy At 3 months after therapy At 6 months after therapy At 12 months after therapy |
A los 30 días después de la terapia A los 3 meses después de la terapia A los 6 meses después de la terapia A los 12 meses después de la terapia |
|
E.5.2 | Secondary end point(s) |
20% improvement in evaluative tests:
Oswestry test Quality of life test SF 12 Mood Assessment Test |
Mejoría del 20% de los tests evaluativos :
Test de Oswestry Test de calidad de vida SF 12 Test de Evaluación estado de ánimo |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days after therapy At 3 months after therapy At 6 months after therapy At 12 months after therapy |
A los 30 días después de la terapia A los 3 meses después de la terapia A los 6 meses después de la terapia A los 12 meses después de la terapia |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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 end of the study would be 12 months after the last therapy of the last recruited patient.
After this moment, the data analysis would be carried out and the final results are expected to be obtained 6 months after the end of the study. |
El Final del estudio seria a los 12meses de la última terapia del último pacinete reclutado.
Pasado este momento se procedería al análisis de datos y se preve obtener los resultados finales a los 6 meses desde la finalización del estudio. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |