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

Sublimed0 sites500 target enrollmentMarch 2020

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Sublimed
Enrollment: 500
Primary Endpoint: Determination of predictive factors explaining compliance to TENS.
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2020

End Date

October 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sublimed

Responsible Party

Sponsor

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
•Major incapable to oppose to the use of their data during the study due to medical or legal decision.
•Having language impairment.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Determination of predictive factors explaining compliance to TENS.

Time Frame: 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.

Secondary Outcomes

Efficacy parameters: observance(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 differences(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)
Tolerance parameters: AEs(Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.)
Efficacy parameters: follow up visits(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(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(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: Impression of change(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)
Mode of 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.)
Tolerance parameters: premature discontinuation(Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.)
Efficacy parameters: Sum of Pain intensity differences(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(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(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(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(Data are collected the day of the inclusion.)