PATIENT-REPORTED-OUTCOMES IN CHRONIC CERVICAL PAIN PATIENTS WITH ACCOMPANYING UPPER LIMB RADIATING 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
- 369
- 试验地点
- 33
- 主要终点
- Change From Baseline at 8 weeks 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 on patient reported outcomes compared with conventional analgesic care in chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated in primary care settings under routine clinical practice.
详细描述
Rational and background:
Cervical pain with upper limb radiating pain(neuropathic component), such as cervical spondylosis radiculopathy or cervical spondylotic myelopathy, is one of the typical and common neuropathic pain. However, in Japan, large number of those patients are treated with NSAIDs without adequately assessing the cause of pain, despite that α2δ ligand, SNRI (Serotonin and Norepinephrine Reuptake Inhibitors ), and TCA (Tricyclic Antidepressants) are recommended in the clinical guidelines for neuropathic pain. Therefore, treatment satisfaction of these patients is low. This is currently a major issue in treatment for cervical pain with neuropathic component in Japan. In fact, our previous study which assessed the effect of pregabalin in low back pain patients with radiculopathy suggested that the selection of appropriate analgesics according to the cause of pain improved pain related sleep interference, pain and function. However, there are a few reports with regard to effect of pregabalin in cervical pain patients with neuropathic component. Therefore, we propose to conduct an observational study in order to assess the effects of pregabalin in cervical radiculopathy, when added to routine clinical care. The present study can encourage an understanding of the necessary of assessing cause of the pain, and treating with appropriate analgesics.
Research objectives :
To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic cervical pain patients with accompanying upper limb radiating pain(neuropathic component) treated in primary care settings under routine clinical practice.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 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 pain with accompanying radiating pain to the superior limb beyond the elbow.
- •Subject is male or female patient ≧20 years old. Subject who reported neck pain with accompanying radiating pain to superior limb (12 weeks or greater in duration at Visit 0).
- •Subject who is refractory to previous analgesics for 12 weeks and more. Subject who is able and willing to complete all study related assessment tools and complied with scheduled clinic visits and clinical study procedures.
- •Subject whose pain NRS ≧5 and PRSIS ≧1 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 was treated with Pregabalin within the past 12 weeks (on baseline). Subject who has been regularly treated cervical pain with nerve blocks (such as stellate ganglion block, epidural block, radicular block and trigger point injection etc.).
结局指标
主要结局
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
时间窗: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). 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
- Change From Baseline in Pain Numeric Rating Scale (Pain NRS - past week recall)(Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation))
- Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-Visual Analogue Scale -(Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation))
- Clinical Global Impression of Change (CGIC)(Final visit (week 8 or discontinuation))
- Change From Baseline in Neck Disability Index (NDI)(Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation))
- Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-QOL-Score-(Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation))
- Patient Global Impression of Change (PGIC)(Final visit (week 8 or discontinuation))
- Work Productivity and Activity Impairment Questionnaire: (WPAI: GH)(Final visit (week 8 or discontinuation))