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

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.

研究概览

地位

完全的

条件

详细说明

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).

研究类型

观察性的

注册 (实际的)

331

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • 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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
The study is observational
Usual care
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
The study is observational

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
大体时间: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-
大体时间: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)
大体时间: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-
大体时间: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 -
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)

其他结果措施

结果测量
大体时间
Number of Patients With Adverse Events
大体时间:Visit2(week4),Final Visit(Week8 or discontinuation)
Visit2(week4),Final Visit(Week8 or discontinuation)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Koichi Fujii, MD、Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年7月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2014年10月17日

首先提交符合 QC 标准的

2014年10月21日

首次发布 (估计)

2014年10月24日

研究记录更新

最后更新发布 (实际的)

2021年2月3日

上次提交的符合 QC 标准的更新

2021年1月15日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • A0081333

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Low-Back Pain的临床试验

No intervention的临床试验

3
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