Clinical Trials Register

Summary
EudraCT Number:	2015-002563-41
Sponsor's Protocol Code Number:	RFCLAI004
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:	2015-11-25
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-002563-41

A.3

Full title of the trial

Prospective, randomized cohort study to evaluate the efficacy of two techniques against chronic knee pain: echo-guided radiofrequency over sensitive nerves of the knee, compared to intraarticular infiltration of corticosteroids plus local anesthetics under fluoroscopic guidance.

Estudio de cohortes prospectivo, aleatorizado, para valorar la eficacia de dos técnicas contra el dolor crónico de rodilla: radiofrecuencia ecoguiada sobre la inervación sensitiva de la rodilla, en comparación con la infiltración intra-articular de corticoides y anestésicos locales guiada por radiografía convencional.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparative study of radiofrequency versus intraarticular corticoid injection for chronic knee pain.

Estudio comparativo de radiofrecuencia contra inyección intra-articular de corticoides para el dolor crónico de rodilla.

A.3.2

Name or abbreviated title of the trial where available

Comparative study of radiofrequency versus intraarticular corticoid injection for chronic knee pain.

Estudio comparativo de radiofrecuencia contra inyección intra-articular de corticoides para el dolor

A.4.1

Sponsor's protocol code number

RFCLAI004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Jorge Orduna Valls
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundacion Ramon Dominguez
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	Instituto de Salud Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aurora Baluja
B.5.2	Functional name of contact point	Anaesthetist - Clinical Trials Info
B.5.3	Address:
B.5.3.1	Street Address	S. Anestesia, Reanimacion e Tratamento da Dor. Travesa Choupana s/n
B.5.3.2	Town/ city	Santiago de Compostela
B.5.3.3	Post code	15706
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034981950674
B.5.5	Fax number	0034981950634
B.5.6	E-mail	mariauror@gmail.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	TRIGON DEPOT 40 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol Myers Squibb, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Triamcinolone acetonide
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	LIDOCAINA INYECTABLE BRAUN Sol. iny. 2%
D.2.1.1.2	Name of the Marketing Authorisation holder	Braun Medical S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lidocaine hydrodhloride
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use Intradermal use Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMNIPAQUE 240 mg Iodo/ml solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	GE Healthcare Bio-Sciences, SAU
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Iohexol
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Chronic knee pain (more than 3 months), in patients either non eligible for knee surgery, or with pain after three months of knee surgery.

Dolor crónico de rodilla (de más de tres meses de duración), en pacientes que, o bien no cumplen criterios médicos para ser operados, o bien presentan dolor al menos durante los tres meses posteriores a la cirugía de rodilla.

E.1.1.1

Medical condition in easily understood language

Chronic knee pain (more than 3 months), in patients that cannot undergo knee surgery, or chronic knee pain in patients after three months of knee surgery.

Dolor crónico de rodilla (de más de tres meses de duración), en pacientes que no pueden ser operados, o bien dolor crónico de rodilla durante los tres meses posteriores a la cirugía de rodilla.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10064332
E.1.2	Term	Complex regional pain syndrome
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of two techniques against chronic knee pain: ultrasound-guided radiofrequency versus the standard treatment (intraarticular injection of corticoids and local anesthetics) assessing:
- The reduction in visual analogic scale (VAS) score at weeks 1, 4, 12, 24 in either group(taking as significative a two-points reduction or a > 50% reduction from the initial VAS score).
- Assessment of functional changes in the knee articulation measured by the Oxford Knee and the WOMAC scores.
- Changes in doses of analgesia administered.
- Patient satisfaction (SF-36 questionnaire).
- Adverse events incidence.

Comparar la eficacia de dos técnicas contra el dolor crónico de rodilla: radiofrecuencia ecoguiada frente al tratamiento estándar (inyección intraarticular de corticoides y anestésicos locales) evaluando:
- Reducción de la escala visual analógica (EVA) en las semanas 1, 4, 12 y 24 para ambos grupos (tomando como significativa una reducción de 2 puntos o de más del 50% sobre el valor inicial).
- Estudio de cambios funcionales de la articulación de la rodilla medidos por la Oxford Knee score y el WOMAC.
- Cambios en las dosis de analgesia administrada.
- Encuesta SF-36 de satisfacción del paciente.
- Inicidencia de eventos adversos.

E.2.2

Secondary objectives of the trial

Determinate the efficacy of the echoguided radiofrequency administration over specific nerve branches in the knee. Those branches were previously localized using simple X-ray imaging.

Determinar la eficacia de la aplicación ecoguiada de las diferentes variantes de radiofrecuencia sobre ramas nerviosas específicas de la articulación de la rodilla. Estas ramas eran hasta ahora localizadas mediante referencias óseas bajo guía radiológica simple.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1- Patient who is informed and gives written consent for study participation.
2- Patients with ages between 40 and 80 years.
3- Non-pregnant women who are willing to adopt effective contraceptive methods during the study.
4- Non-fertile women.
5- Chronic gonalgia (> 3 months) that didn?t respond to conservative treatment, pharmacologic therapy, TENS or rehabilitation.
6- Mechanic-type pain in the affected limb with VAS score > 50 mm during strolling.
7- Stable doses in antialgic drugs for more than 30 days before study initiation.
8- Osteoarthrosis with Kellgren-Lawrence degrees II, III, IV.
9- Patients who underwent Knee Society's Knee Scoring System (KSS).
10- Pain improvement greater than 50% (VAS) after nerve infiltration with local anesthesia.
11- Absence of allergy or reported adverse events after the administration of local anesthetics, steroids or iodinated contrasts.
12- Patients who understood the risks and benefits of the two procedures studied.
13- Patients who are able to attend all the visits scheduled for the study.

1- Paciente que ha sido informado y ha dado su consentimiento por escrito para participar.
2- Paciente con edades entre 40 y 80 años.
3- Mujeres en edad fértil no embarazadas que se comprometen a utilizar un método contraceptivo eficaz durante el estudio.
4- Mujeres no fértiles o en edad no fértil.
5- Gonalgia crónica (más de 3 meses) que no ha respondido a tratamiento conservador, terapia farmacológica, fisioterapia o TENS).
6- Dolor de tipo mecánico en el miembro afectado con un EVA de al menos 50 mm durante la deambulación.
7- Osteoartrosis moderada a severa determinada con grados Kellgren-Lawrence II, III, IV.
8- Dosis estables de analgésicos al menos durante 30 días antes de iniciar el estudio.
9- Pacientes que han realizado el test Knee Society's Knee Scoring System (KSS) y WOMAC 3 meses o menos antes del estudio.
10- Mejoría del dolor en al menos un 50% tras infiltración del nervio con anestésico local.
11- Ausencia de alergia o eventos adversos conocidos a alguno de los medicamentos administrados: anestésicos locales de grupo amida, esteroides y contrastes iodados.
12- Pacientes que han comprendido los riesgos y beneficios de los procedimientos.
13- 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.

E.4

Principal exclusion criteria

1- Signs of alarm or infection in the affected joint.
2- Signs of systemic infection or VIH.
3- Severe psychiatric disorders.
4- Pain with unexplained weight loss of > 5% 90 days before the study.
5- Neuropathic pain in the affected limb.
6- Patients with cancer in the five years before the study, or who have cancer at the time of the study.
7- Patients with coagulation disorders or antiagregant/anticoagulant (except Aspirin < 150 or 300 mg/day) drugs that cannot be discontinued during their recommended intervals before the procedures.
8- Participants in any clinical study at least 30 days before screening.
9- Substance abuse disorders.
10- Patients who are trying to obtain a sick leave, or being recognized with some degree of disability.
11- Pregnancy, or patient not willing to adopt contraceptive methods.
12- Patient under opioid treatment with doses greater than 90 miligrams a day.

1- Signos de alarma o infección en la articulación afecta.
2- Signos de infección activa, inmunosupresión o VIH activo.
3- Enfermedades psiquiátricas severas.
4- Dolor sumado a una pérdida no explicada de peso de más del 5% 90 días o menos antes del inicio del estudio.
5- Dolor de origen radicular establecido en la extremidad afectada, o enfermedades neurodegenerativas del Sistema nervioso periférico.
6- Pacientes con patología tumoral de base o que hayan tenido cáncer en los cinco años previos a la inclusión.
7.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.
8- Paciente que haya participado en un estudio clínico los 30 días previos a la inclusión en este estudio.
9- Paciente con diagnóstico de trastorno por abuso de sustancias o alcoholismo.
10- Paciente que se encuentre en trámites para la adjudicación de una baja o grado de incapacidad.
11- Paciente embarazada, o que no esté dispuesta a garantizar la anticoncepción durante el estudio.
12- Paciente bajo tratamiento con opioides con dosis mayores que la equivalente a 90 miligramos de morfina oral/día.

E.5 End points

E.5.1

Primary end point(s)

Visual Analogic scale (VAS) reduction > 50% from baseline or 2-points reduction at various time points: 1, 4, 12 and 24 weeks.

Reducción en la escala visual analógica de más del 50% del basal o una reducción de 2 puntos del basal a varios intervalos temporales: 1, 4, 12 y 24 semanas.

E.5.1.1

Timepoint(s) of evaluation of this end point

1, 4, 12 and 24 weeks.

1, 4, 12 y 24 semanas.

E.5.2

Secondary end point(s)

- Assessment of functional changes in the knee articulation measured by the Oxford Knee and the WOMAC scores.
- Changes in doses of analgesia administered.
- Patient satisfaction (SF-36 questionnaire).
- Adverse events incidence.

- Estudio de cambios funcionales de la articulación de la rodilla medidos por la Oxford Knee score y el WOMAC.
- Cambios en las dosis de analgesia administrada.
- Encuesta SF-36 de satisfacción del paciente.
- Inicidencia de eventos adversos.

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 4, 12 and 24 weeks.

1, 4, 12 y 24 semanas.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Los comparadores son medicamentos. El producto evaluado es un aparato contra varios medicamentos

The comparators are medicinal products. The tested product is a medical device against IMPs

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

The study will be prematurely terminated in the case there is found either any significant increase in complications derived from radiofrequency, or an unefectiveness of the technique. Otherwise, the study will continue until the last visit of the last patient.

El estudio se finalizará prematuramente si se demuestra, en análisis internos, un aumento significativo de las complicaciones asociadas a la radiofrecuencia, o bien su falta de efectividad. En caso contrario, el estudio seguirá hasta completar la última visita del último paciente.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

- VAS score
- Therapeutic alternatives in case of treatment failure
- Assessment of functional changes in the knee articulation measured by the Oxford Knee and the WOMAC scores.
- Changes in doses of analgesia administered.
- Adverse events incidence.

- Puntuación EVA
- Alternativas terapéuticas en caso de fracaso del tratamiento
- Estudio de cambios funcionales de la articulación de la rodilla medidos por la Oxford Knee score y el WOMAC.
- Cambios en las dosis de analgesia administrada.
- Inicidencia de eventos adversos.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-01

P. End of Trial
P.	End of Trial Status	Ongoing

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