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Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain (IPATENS)

31. januar 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Chronic pain patients
Andet: Questionnaires

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Determination of predictive factors explaining compliance to TENS.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy parameters: follow up visits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sublimed

Efterforskere

  • Ledende efterforsker: Muriel PERRIOT MOREY, Chateauroux hospital - Pain managment center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2020

Primær færdiggørelse (Forventet)

1. oktober 2020

Studieafslutning (Forventet)

1. oktober 2020

Datoer for studieregistrering

Først indsendt

31. januar 2020

Først indsendt, der opfyldte QC-kriterier

31. januar 2020

Først opslået (Faktiske)

5. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IPATENS

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