Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain (IPATENS)
2020年1月31日 更新者：Sublimed
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.
調査の概要
研究の種類
観察的
入学 (予想される)
500
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：断面図
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Chronic pain patients
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Determination of predictive factors explaining compliance to TENS.
時間枠：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.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Efficacy parameters: follow up visits
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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).
|
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
時間枠：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).
|
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
時間枠：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.
|
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
時間枠：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
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：Data are collected the day of the inclusion.
|
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
時間枠：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.
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
|
Tolerance parameters: AEs
時間枠：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.
|
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
時間枠：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
|
Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Muriel PERRIOT MOREY、Chateauroux hospital - Pain managment center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2020年3月1日
一次修了 (予想される)
2020年10月1日
研究の完了 (予想される)
2020年10月1日
試験登録日
最初に提出
2020年1月31日
QC基準を満たした最初の提出物
2020年1月31日
最初の投稿 (実際)
2020年2月5日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月5日
QC基準を満たした最後の更新が送信されました
2020年1月31日
最終確認日
2020年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。