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

31 januari 2020 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Förväntat)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Tvärsnitt

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Chronic pain patients
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Determination of predictive factors explaining compliance to TENS.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Efficacy parameters: follow up visits
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sublimed

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 mars 2020

Primärt slutförande (Förväntat)

1 oktober 2020

Avslutad studie (Förväntat)

1 oktober 2020

Studieregistreringsdatum

Först inskickad

31 januari 2020

Först inskickad som uppfyllde QC-kriterierna

31 januari 2020

Första postat (Faktisk)

5 februari 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IPATENS

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

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