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

NCT04253639 | Unknown

• 1 other identifier: IPATENS
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Keywords

TENS; Predictive factors; Compliance; Chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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: 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

  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

  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

  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

Study Arms (1)

Chronic pain patients

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

Chronic pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sublimed: lead

MeSH Terms

Conditions

Chronic Pain; Patient Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Muriel PERRIOT MOREY

  Chateauroux hospital - Pain managment center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Abraham-Briffod

CONTACT

+33 (0)4 76 37 17 58; contact@subli-med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share