E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hip Pain by Osteoarthrosis |
Dolor crónico de cadera por Artrosis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic hip pain secondary a arthoris |
Dolor de cadera por artrosis |
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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 |
To evaluate the efficacy of two techniques against chronic hip pain: cooled radiofrequency over sensitive nerves of the hip, compared to intraarticular injection of steroids and local anestethic under fluoroscopic guidance on the hip. |
Comparar la eficacia de dos técnicas contra el dolor crónico de cadera: radiofrecuencia cooled sobre la inervación sensitiva de la cadera y la infiltración intra-articular de anestésico local y corticoide. |
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E.2.2 | Secondary objectives of the trial |
638/5000 - To compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales. -Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques. - To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale. |
-Comparar la mejoría de la capacidad funcional de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por las escalas WOMAC y Oxford Hip score. -Comparar la duración de la mejoría clínica en términos de reducción de dolor cuantificada por la escala VAS (escala visual analógica) al año tras la aplicación de ambas técnicas. - Comparar la mejoría de la calidad de vida de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por la escala SF 36.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Patient over 18 years old. 2- Chronic hip pain (more than 3 months) that has not responded to conservative treatment, pharmacological therapy, physiotherapy or TENS). 3- Mechanical pain in the affected limb with a VAS of at least 50 mm during ambulation. 4- Patients for whom it is possible to carry out all the scheduled visits of the study, with the capacity to attend within the established deadlines for the control visits. 5- Greater than 50% improvement in the VAS scale after the two anesthetic blocks performed with local anesthetics of different duration (levobupivacaine 0.25% and mepivacaine 2%) 6- Moderate to severe osteoarthrosis determined with degrees Kellgren-Lawrence II, III, IV. 7- Stable doses of analgesics at least 30 days before starting the study. 8- Patients who have performed the Oxford Hip Score and WOMAC test 3 months or less before the study. 9- Absence of allergy or adverse events known to any of the medications administered: local anesthetics of amide group and iodinated contrasts. 10-Negative pregnancy test (women of childbearing age) and commitment to guarantee contraception during the study
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1- Paciente mayor a 18 años. 2- Dolor de cadera crónico (más de 3 meses) que no ha respondido a tratamiento conservador, terapia farmacológica, fisioterapia o TENS). 3- Dolor de tipo mecánico en el miembro afectado con un VAS de al menos 50 mm durante la deambulación. 4- Pacientes para los que es posible realizar todas las visitas programadas del estudio, con capacidad para acudir en los plazos establecidos a las visitas de control. 5- Mejoría mayor al 50% en la escala VAS tras los dos bloqueos anestésicos realizados con anestésicos locales de diferente duración (levobupivacaina 0,25% y mepivacaina 2%) 6- Osteoartrosis moderada a severa determinada con grados Kellgren-Lawrence II, III, IV. 7- Dosis estables de analgésicos al menos durante 30 días antes de iniciar el estudio. 8- Pacientes que han realizado el test Oxford Hip Score y WOMAC 3 meses o menos antes del estudio. 9- Ausencia de alergia o eventos adversos conocidos a alguno de los medicamentos administrados: anestésicos locales de grupo amida y contrastes iodados. 10-Test de embarazo negativo (mujeres en edad fértil) y compromiso de garantizar la anticoncepción durante el estudio
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E.4 | Principal exclusion criteria |
1- Signs of alarm or infection in the joint affects. 2- Signs of active infection, immunosuppression or active HIV. 3- Severe psychiatric illnesses. 4-Patient carrier of hip prosthesis. 5- Pain added to an unexplained weight loss of more than 5% 90 days or less before the start of the study. 6- Pain of root origin established in the affected limb, or neurodegenerative diseases of the peripheral nervous system. 7- Patients with basic tumor pathology or who have had cancer in the five years prior to inclusion. 8- Alterations of the coagulation or taking of anticoagulants / antiaggregants (except aspirin 150 or 300 mg / day) at the beginning of the study, which can not be suspended for basic pathology during a prudent interval for the realization of the technique. 9- Patient who has participated in a clinical study for the previous 30 days in which interventions are performed that may affect the results of the study. 10- Patient with a diagnosis of disorder due to substance abuse or alcoholism. 11- Patient who is in process for the award of a disability or degree of disability. 12- Pregnant or lactating patient. 13- Patient under treatment with opioids with doses greater than the equivalent to 90 milligrams of oral morphine / day.
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1- Signos de alarma o infección en la articulación afecta. 2- Signos de infección activa, inmunosupresión o VIH activo. 3- Enfermedades psiquiátricas severas. 4-Paciente portador de prótesis de cadera. 5- Dolor sumado a una pérdida no explicada de peso de más del 5% 90 días o menos antes del inicio del estudio. 6- Dolor de origen radicular establecido en la extremidad afectada, o enfermedades neurodegenerativas del Sistema nervioso periférico. 7- Pacientes con patología tumoral de base o que hayan tenido cáncer en los cinco años previos a la inclusión. 8- Alteraciones de la coagulación o toma de anticoagulantes/antiagregantes (salvo aspirina 150 o 300 mg/día) al inicio del estudio, que no puedan ser suspendidos por patología de base durante un intervalo prudente para la realización de la técnica. 9- Paciente que haya participado en un estudio clínico los 30 días previos en los que se realizan intervenciones que pueden afectar a los resultados del estudio. 10- Paciente con diagnóstico de trastorno por abuso de sustancias o alcoholismo. 11- Paciente que se encuentre en trámites para la adjudicación de una baja o grado de incapacidad. 12- Paciente embarazada o en periodo de lactancia. 13- Paciente bajo tratamiento con opioides con dosis mayores que la equivalente a 90 miligramos de morfina oral/día.
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E.5 End points |
E.5.1 | Primary end point(s) |
a)-Improvement more than 50% in VAS score in patients under treatment with Intraarticular injection or cooled radiofrequency b)-Duration of the clinical effect in terms of pain reduction (quantified by a 50% reduction in the VAS scale with respect to the baseline level) |
- Porcentaje de sujetos con mejoría en los dos grupos definido como reducción del VAS mayor al 50 % respecto al basal a los tres meses desde la aplicación de la técnica. -Comparar la persistencia del efecto clínico en términos de reducción de dolor (cuantificada por una reducción del 50% en la escala VAS respecto al nivel basal) a los seis meses tras la aplicación de la radiofrecuencia cooled sobre ramas nerviosas sensitivas de la cadera respecto a la inyección intra articular de anestésico local y corticoide. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
a)-3 months b)-6 months |
a)3 meses b) 6 meses
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E.5.2 | Secondary end point(s) |
- Compare the improvement of the functional capacity of patients subjected to radiofrequency cooled compared to those treated by intra-articular injection of local anesthetic and corticosteroid measured by the WOMAC and Oxford Hip score scales. -Compare the duration of the clinical improvement in terms of pain reduction quantified by the VAS scale (visual analog scale) a year after the application of both techniques. - To compare the improvement of the quality of life of patients subjected to cooled radiofrequency compared to those treated by intra-articular injection of local anesthetic and corticosteroid as measured by the SF 36 scale. |
-Comparar la mejoría de la capacidad funcional de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por las escalas WOMAC y Oxford Hip score. -Comparar la duración de la mejoría clínica en términos de reducción de dolor cuantificada por la escala VAS (escala visual analógica) al año tras la aplicación de ambas técnicas. - Comparar la mejoría de la calidad de vida de los pacientes sometidos a radiofrecuencia cooled respecto a los tratados mediante inyección intra articular de anestésico local y corticoide medida por la escala SF 36. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-One month from treatments day. -Thee months from treatments day. -Six Months from treatments day. -12 Months from treatments day. -24 Months from treatments day. |
- Un mes tras el tratamiento - Tres meses tras el tratamiento - Seis meses tras el tratamiento - 12 meses tras el tratamiento - 24 meses tras el tratamiento |
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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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Yes |
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
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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 | |