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

Chronic Pain Clinical Trial

— IPATENS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04253639
• Other study ID #: IPATENS
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: October 2020

Study information

• Verified date: January 2020
• Source: Sublimed
• Contact: Patricia Abraham-Briffod
• Phone: +33 (0)4 76 37 17 58
• Email: contact[@]subli-med.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sublimed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of predictive factors explaining compliance to TENS.	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
Secondary	Efficacy parameters: follow up visits	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
Secondary	Efficacy parameters: observance	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
Secondary	Efficacy parameters: pain intensity	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
Secondary	Efficacy parameters: Pain intensity differences	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
Secondary	Efficacy parameters: Sum of Pain intensity differences	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 = S [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
Secondary	Efficacy parameters: punctual relief	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
Secondary	Efficacy parameters: Total relief	Total relief (TOTPAR) or TOTPARt0-tx = S [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
Secondary	Efficacy parameters: Quality of life	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
Secondary	Efficacy parameters: Impression of change	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
Secondary	Efficacy parameters: Satisfaction	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
Secondary	Efficacy parameters: wish for continuation	Number of patients wishing to continue treatment and purchase the device	Data are collected the day of the inclusion.
Secondary	Mode of use of the TENS	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.
Secondary	Tolerance parameters: AEs	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.
Secondary	Tolerance parameters: premature discontinuation	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.