Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 33
- 主要终点
- Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subject who received the enough study information and signed informed consent form.
- •Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
- •Subject is male or female patient ≥18 years old.
- •Subject who has complained low back pain for 3 months or more before Visit
- •Subject who is refractory to prior analgesics for 3 months and more.
- •Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
- •Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)
排除标准
- •Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
- •Subject who has been already treated by pregabalin
结局指标
主要结局
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
时间窗: 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.
次要结局
- Work Productivity and Activity Impairment Scale (WPAI:LBP)(Final Visit (Week8 or discontinuation))
- Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-(Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation))
- Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-(Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation))
- Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)(Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation))
- Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-(Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation))
- Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -(Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation))
- Clinical Global Impression of Change (CGIC)(Final Visit (Week8 or discontinuation))
- Patient Global Improvement of Change (PGIC)(Final Visit (Week8 or discontinuation))