Clinical trial NCT04253639: Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
Official title: Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: TENS
Predictive factors
Compliance
Chronic pain
Lead sponsor: Sublimed
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of predictive factors explaining compliance to TENS.
timeFrame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
Secondary outcomes:
measure: Efficacy parameters: follow up visits
timeFrame: 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
measure: Efficacy parameters: observance
timeFrame: 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
measure: Efficacy parameters: pain intensity
timeFrame: 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
measure: Efficacy parameters: Pain intensity differences
timeFrame: 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
measure: Efficacy parameters: Sum of Pain intensity differences
timeFrame: 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
measure: Efficacy parameters: punctual relief
timeFrame: 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
measure: Efficacy parameters: Total relief
timeFrame: 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
measure: Efficacy parameters: Quality of life
timeFrame: 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
measure: Efficacy parameters: Impression of change
timeFrame: 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
measure: Efficacy parameters: Satisfaction
timeFrame: 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
measure: Efficacy parameters: wish for continuation
timeFrame: Data are collected the day of the inclusion.
measure: Mode of use of the TENS
timeFrame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
measure: Tolerance parameters: AEs
timeFrame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
measure: Tolerance parameters: premature discontinuation
timeFrame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Other outcomes:
Locations:
Study officials:
affiliation: Chateauroux hospital - Pain managment center
name: Muriel PERRIOT MOREY
role: PRINCIPAL_INVESTIGATOR
References: