NCT04253639Unknown不适用
Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Sublimed
- 入组人数
- 500
- 主要终点
- Determination of predictive factors explaining compliance to TENS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Having difficulties understanding the French language.
- •Unable to participate in the phone survey.
- •Not affiliated with Health Insurance / Social Security.
排除标准
- 未提供
结局指标
主要结局
Determination of predictive factors explaining compliance to TENS.
时间窗: 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.
次要结局
- 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.)
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