Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain (IPATENS)
31 de enero de 2020 actualizado por: Sublimed
This is a retrospective and transverse multicenter study to identify predictive factors for adherence to TENS by chronic pain patients followed in structures specialized in Chronic Pain management (SPC).
The study contains 2 parts:
- A retrospective part of data collection in the patient follow-up file of the SPC during the 6 months elapsed after the first rental prescription.
- A transversal part, aimed at collecting additional information on the use of TENS, satisfaction and quality of life during a telephone interview after 6 months of use.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Anticipado)
500
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
The population studied is all adult chronic pain patients, who have benefited from an initiation of treatment with TENS dating back at least 6 months within a centre specialized in chronic pain management identified and labeled by a local regulatory agency.
Patients who agree to participate in the study will be recruited in reverse chronological order from the list of patients in the active queue of each centre. Ten patients will be recruited by each investigator with a total of 50 centers.
Descripción
Inclusion Criteria:
- Aged 18 and over when TENS was implemented.
- Suffering from chronic pain.
- Follow-up in nurse consultation within a centre specialized in chronic pain management identified and labeled by a local regulatory agency.
- Benefiting from the implementation of TENS for more than 6 months by a nurse from a centre specialized in chronic pain management.
- Affiliate or Beneficiary of a health insurance scheme.
- For patients in the study population: Having expressed their non-opposition to participate in the study.
- Patient used to verify the representativeness of the population studied: Unable to be contacted by phone and not having expressed their refusal to participate or for which the mail has not returned undelivered
Non-inclusion criteria
- Minor.
- Major incapable to oppose to the use of their data during the study due to medical or legal decision.
- Having language impairment.
- Having difficulties understanding the French language.
- Unable to participate in the phone survey.
- Not affiliated with Health Insurance / Social Security.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Chronic pain patients
|
Patients must fill questionnaires to collect socio-demographics, aetiology and characteristics of pain, efficacy and tolerance regarding the TENS. Study sites must fill questionnaires to collect information regarding the type of pain management centre, the characteristics of the clinician, the characteristics of the TENS prescribed. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determination of predictive factors explaining compliance to TENS.
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
|
Compliance is evaluated on a 6 month period prior to the inclusion.
Compliant patients to TENS are defined as having 0, 1 or 2 to score of Morisky Medication Adherence Scale.
Factors which can explain the lack of compliance will be collected and categorized within "pain centre", "clinician", "TENS characteristics", "patient socio-demographics", "aetiology and characteristics of pain", "efficacy and tolerance" data.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Efficacy parameters: follow up visits
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
|
Efficacy parameters: Rate of patients followed at 1, 3 and 6 months after the initiation session to TENS and rate and time of premature discontinuation of treatment.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
|
|
Efficacy parameters: observance
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
|
Rate of observant patients at 1, 3 and 6 months after the TENS initiation session.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
|
|
Efficacy parameters: pain intensity
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
Pain intensity (PI) collected using an 11 point digital scale (EN) (0 - 10, 0 = no pain; 10 = maximum pain imaginable) during the first contact with the investigator/nurse (D0) (patient record), then 1, 3 and 6 months after the TENS initiation session (patient record) and during the 8 days preceding the last use of TENS.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
|
Efficacy parameters: Pain intensity differences
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
Pain intensity differences (PID) on the average intensity scores at 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of TENS (PI inclusion - PI T-time).
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
|
Efficacy parameters: Sum of Pain intensity differences
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
Sum of pain intensity differences (SPID) on the average intensity scores at 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of TENS, weighted on the time factor: SPID0-Xmonth = Σ [T (i) -T (i-1)] xPID (i).
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
|
Efficacy parameters: punctual relief
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
Relief (PAR) using an 11-point numeric scale (0% -100%, 0 = no relief; 100% = complete relief) at 1, 3 and 6 months (patient record) after the introduction to TENS and during the 8 days preceding the last use of TENS.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
|
Efficacy parameters: Total relief
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
Total relief (TOTPAR) or TOTPARt0-tx = Σ [T (x) -T (x-1)] xPAR (x) when T (0) = 0, T (x) is the selected evaluation time and PAR (x) is the PAR value at the times 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of the TENS
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
|
|
Efficacy parameters: Quality of life
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
Quality of life questionnaire (EQ-5D) when TENS was last used.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
|
Efficacy parameters: Impression of change
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
Patients' Global Impression of Change (PGIC) when the TENS was last used.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
|
Efficacy parameters: Satisfaction
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
Satisfaction when TENS was last used.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
|
|
Efficacy parameters: wish for continuation
Periodo de tiempo: Data are collected the day of the inclusion.
|
Number of patients wishing to continue treatment and purchase the device
|
Data are collected the day of the inclusion.
|
|
Mode of use of the TENS
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
For each of the 4 TENS allowed in the study, description of the program used and collection of the duration of use, the number of sessions per day and the duration of the post-effect as well as compliance with the instructions for use of the TENS during follow-up.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
|
Tolerance parameters: AEs
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
Number, delay of onset and type of serious and non-serious AEs (SAEs) occurring during the 6 months of follow-up and attributable, according to the opinion of the investigator, to treatment.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
|
Tolerance parameters: premature discontinuation
Periodo de tiempo: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
Number of premature discontinuations before 6 months for tolerance problems
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Muriel PERRIOT MOREY, Chateauroux hospital - Pain managment center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de marzo de 2020
Finalización primaria (Anticipado)
1 de octubre de 2020
Finalización del estudio (Anticipado)
1 de octubre de 2020
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2020
Primero enviado que cumplió con los criterios de control de calidad
31 de enero de 2020
Publicado por primera vez (Actual)
5 de febrero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
31 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IPATENS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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