このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin (PRO)

2021年1月15日 更新者：Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings

The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Rational and background :

The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient.

And the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves.

On the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and QOLs by Patient-reported outcomes.

Research question and objectives :

To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Study design:

This is an 8-week, multicenter prospective observational study. Subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. The analgesic treatment is determined by the clinical judgment of the physician in charge of patient management. This therapeutic choice is not related to the decision to take part in the study. All enrolled subjects will be received with analgesic treatment. The study requires 3 visits at least, baseline/enrollment visit, Week 4 visit and Week 8 visit (or discontinuation).

研究の種類

観察的

入学 (実際)

331

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。

研究場所

  • 日本
      • Kagoshima、日本
        • Nakamura Orthopaedic Clinic
      • Kagoshima、日本
        • Showa-kai Clinic
      • Miyazaki、日本
        • Clinic Ushitani
      • Miyazaki、日本
        • Kohnan Matsumoto Orthopaedic Clinic
      • Saitama、日本
        • Iwasaki Orthopaedic Clinic
    • Aichi
      • Nagoya、Aichi、日本
        • Kimura Clinic
    • Chiba
      • Ichikawa、Chiba、日本、272-0133
        • Jin Orthopaedic Clinic
      • Ichikawa、Chiba、日本
        • Satoh Orthopaedic Clinic
      • Ichikawa、Chiba、日本
        • Shiraishi Orthopaedic Clinic
    • Kanagawa
      • Kawasaki、Kanagawa、日本
        • Ota General Hospital
      • Sagamihara、Kanagawa、日本
        • Aoki Orthpaedic Clinic
      • Yokohama、Kanagawa、日本
        • Hiyoshi Hocho Clinic
      • Yokohama、Kanagawa、日本
        • Yamamoto Memorial Hospital
    • Saitama
      • Ageo、Saitama、日本
        • Ageo Medical Clinic
      • Fujimino、Saitama、日本
        • Arai Orthopaedic Clinic
    • Tokyo
      • Adachi、Tokyo、日本
        • Nakaicho Clinic
      • Chiyoda、Tokyo、日本
        • Mitsuda Orthopaedic Clinic
      • Chuo、Tokyo、日本
        • Kyobashi Orthopaedic Clinic
      • Edogawa、Tokyo、日本
        • Morishima Clinic
      • Kita、Tokyo、日本
        • Kita Akabane Orthopaedic Clinic
      • Kita、Tokyo、日本
        • Takeuchi Orthopaedic Clinic
      • Koganei、Tokyo、日本
        • Tanaka Orthopaedic Clinic
      • Koto、Tokyo、日本
        • Araki Clinic
      • Meguro、Tokyo、日本
        • Kohsei Chuo General Hospital
      • Meguro、Tokyo、日本
        • Meguro Seikeigeka Naika
      • Meguro、Tokyo、日本
        • Meguro Yuai Clinic
      • Ohta、Tokyo、日本
        • Takemoto Orthopaedic Clinic
      • Shinagawa、Tokyo、日本
        • Shiotani Pain Clinic
      • Toshima、Tokyo、日本
        • Daido Hospital
      • Toshima、Tokyo、日本
        • Senkawa Shinoda Orthopaedic Clinic
      • Toshima、Tokyo、日本
        • Takahashi Orthopaedic Clinic
    • Yokohama
      • Kanazawa、Yokohama、日本
        • Kanazawa Hospital
      • Tsurumi、Yokohama、日本
        • Katayama Orthopaedic Memorial Hospital

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

非確率サンプル

調査対象母集団

Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics

説明

Inclusion Criteria:

  1. Subject who received the enough study information and signed informed consent form.
  2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
  3. Subject is male or female patient ≥18 years old.
  4. Subject who has complained low back pain for 3 months or more before Visit 1.
  5. Subject who is refractory to prior analgesics for 3 months and more.
  6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
  7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)

Exclusion Criteria:

  1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
  2. Subject who has been already treated by pregabalin

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：他の
  • 時間の展望：見込みのある

コホートと介入

グループ/コホート
介入・治療
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
他の：No intervention
The study is observational
Usual care
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
他の：No intervention
The study is observational

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
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
時間枠：Baseline, Final Visit (Week 8)
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.
Baseline, Final Visit (Week 8)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
時間枠：Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
時間枠：Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
時間枠：Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
時間枠：Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
時間枠：Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.

The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Clinical Global Impression of Change (CGIC)
時間枠：Final Visit (Week8 or discontinuation)
The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).
Final Visit (Week8 or discontinuation)
Patient Global Improvement of Change (PGIC)
時間枠：Final Visit (Week8 or discontinuation)
The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Final Visit (Week8 or discontinuation)
Work Productivity and Activity Impairment Scale (WPAI:LBP)
時間枠：Final Visit (Week8 or discontinuation)

The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline.

In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities.
Final Visit (Week8 or discontinuation)

その他の成果指標

結果測定
時間枠
Number of Patients With Adverse Events
時間枠：Visit2(week4),Final Visit(Week8 or discontinuation)
Visit2(week4),Final Visit(Week8 or discontinuation)

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

捜査官

  • スタディディレクター：Koichi Fujii, MD、Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2014年7月1日

一次修了 (実際)

2015年2月1日

研究の完了 (実際)

2015年3月1日

試験登録日

最初に提出

2014年10月17日

QC基準を満たした最初の提出物

2014年10月21日

最初の投稿 (見積もり)

2014年10月24日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月3日

QC基準を満たした最後の更新が送信されました

2021年1月15日

最終確認日

2016年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A0081333

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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。

Low-Back Painの臨床試験

No interventionの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Poland

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する