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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic pain patients<br> | Other: Questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 = 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, Predictive factors, Compliance, Chronic pain