E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic shoulder pain |
Dolor de hombro crónico |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic shoulder pain |
Dolor de hombro crónico |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 |
Evaluation of the shoulder functionality and pain with the SPADI test (Shoulder Pain and Disability Index), in patients with chronic shoulder pain after tratment with suprascapular nerve block with corticoids versus pulsed radiofrequency. |
Evaluación de la mejora en funcionalidad y dolor en el hombro medida con el test SPADI, en pacientes con dolor crónico de hombro aplicando el bloqueo del nervio supraescapular con corticoides versus radiofrecuencia pulsada |
|
E.2.2 | Secondary objectives of the trial |
- Pain evaluation with visual analog scale (VAS) and numeric rating scale (NRS). - Shoulder range of movement evaluarion: elevation, abduction and external rotation. - Assessment of the reduction in the requirement of analgesics. - Assessment of the state of anxiety and quality of life (HAD test, EuroQoL 5D test). - Assessment of sleep quality (MOS scale) - Assessment of patient satisfaction with the treatment received. - Comparison of safety between both techniques |
- Valoración del dolor utilizando la escala visual analógica (EVA) y escala verbal numérica (EVN). - Valoración de la movilidad tanto activa como pasiva; rango de movimiento del hombro. Elevación, abducción y rotación externa del hombro. - Valoración de la disminución del requerimiento de analgésicos. - Valoración del estado de ansiedad y calidad de vida (escala HAD, EuroQoL). - Valoración de la calidad del sueño (escala MOS) - Valoración de la satisfacción del paciente con el tratamiento recibido. - Comparación de la seguridad entre ambas técnicas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men and women with chronic shoulder pain proposed for suprascapular nerve block. - Age > 18 years - Painful shoulder for more than 3 months. - Informed consent document accepted |
- Hombres y mujeres propuestos para realización de bloqueo del nervio supraescapular por omalgia. - Edad >18 años - Omalgia de >3 meses de duración. - Firma del documento de consentimiento informado |
|
E.4 | Principal exclusion criteria |
- Corticoids allergy - Patient denial - Blood dyscrasias - Inabilility to perform infiltration due to technical difficulty - Not able to understand the informed consent document - Pregnancy or lactation - External causes of shoulder pain: secondary to cerevbrovascular accident, post-surgical, cervicobrachial syndrome - Polimyalgic syndromes - Participation in other studies that may alter the results |
- Alergia a corticoides - Negación del paciente - Discrasias sanguíneas - Imposibilidad de realizar la infiltración por dificultad técnica - No capacidad de comprensión del documento de consentimiento informado - Embarazo o lactancia - Causas externas de omalgia; secundaria a ictus, postquirúrgica (cirugía sobre el hombro, cirugía laparoscópica o cirugía torácica), síndrome cervicobraquial - Algias intensas en otras localizaciones - Participación en otros estudios que puedan alterar los resultados |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SPADI test evaluation |
Test SPADI |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1st, 4th and 12th weeks |
1º, 4º y 12º semanas |
|
E.5.2 | Secondary end point(s) |
VAS and NRS evaluation Shoulder range of movement Analgesic requirements evaluation Anxiety and quality of life Quality of sleep Patient satisfaction |
Evaluación mediante EVA y EVN Rango de movimiento del hombro Cantidad de analgésicos administrados Ansiedad y calidad de vida Calidad del sueño Satisfacción del paciente |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1st, 4th and 12th weeks |
1º, 4º y 12º semanas |
|
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 | No |
E.6.4 | Safety | Yes |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Radiofrecuencia pulsada |
Pulsed radiofrequency |
|
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
|
LVLS |
Última visita del último sujeto |
|
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 | |
E.8.9.1 | In the Member State concerned days | |