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

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ClinicalTrials.gov Identifier: NCT04253639
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sublimed

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.

Condition or disease Intervention/treatment
Chronic Pain Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Chronic pain patients 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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy parameters: follow up visits [ Time Frame: 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.

  2. Efficacy parameters: observance [ Time Frame: 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.

  3. Efficacy parameters: pain intensity [ Time Frame: 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.

  4. Efficacy parameters: Pain intensity differences [ Time Frame: 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).

  5. Efficacy parameters: Sum of Pain intensity differences [ Time Frame: 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).

  6. Efficacy parameters: punctual relief [ Time Frame: 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.

  7. Efficacy parameters: Total relief [ Time Frame: 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

  8. Efficacy parameters: Quality of life [ Time Frame: 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.

  9. Efficacy parameters: Impression of change [ Time Frame: 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.

  10. Efficacy parameters: Satisfaction [ Time Frame: 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.

  11. Efficacy parameters: wish for continuation [ Time Frame: Data are collected the day of the inclusion. ]
    Number of patients wishing to continue treatment and purchase the device

  12. Mode of use of the TENS [ Time Frame: 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.

  13. Tolerance parameters: AEs [ Time Frame: 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.

  14. Tolerance parameters: premature discontinuation [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253639


Contacts
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Contact: Patricia Abraham-Briffod +33 (0)4 76 37 17 58 contact@subli-med.com

Sponsors and Collaborators
Sublimed
Investigators
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Principal Investigator: Muriel PERRIOT MOREY Chateauroux hospital - Pain managment center
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Responsible Party: Sublimed
ClinicalTrials.gov Identifier: NCT04253639    
Other Study ID Numbers: IPATENS
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sublimed:
TENS
Predictive factors
Compliance
Chronic pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms