The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS)
研究概览
简要总结
This is a prospective, randomized, single blinded, two-arm, head to head study.
The purpose of this study is:
- To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain.
Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving functional disabilities and in reducing pain resulting from acute low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to 1-Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The investigator and care provider will be blind to group. Participant will know their treatment.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects underwent a detailed history and systemic physical examination including neurologic and musculoskeletal evaluations. To rule out any confounding etiologies, basic diagnostic laboratory tests including complete blood count and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were performed. The patients diagnosed as having acute non-specific low back pain according to history and physical examinations were invited to participate and will be informed about the purpose and course of the study.
- •Main inclusion criteria
- •A primary complaint of pain in the area between the 12th rib and buttock crease without leg pain
- •Female or male, 20 - 80 years of age
- •Low back pain of less than six weeks' duration; and at least moderate pain intensity (NRS≧4)
排除标准
- •Main exclusion criteria:
- •Known or suspected serious spinal pathology and spinal implants
- •Lumbar spinal surgery within the preceding six months
- •Serious comorbidities preventing prescription of paracetamol
- •Alternative treatment for low back pain in previous two weeks
- •Chronic neurological lesion
- •Chronic musculoskeletal lesion
- •Active cancer
- •Pregnancy
- •Use of pain medication (except paracetamol) within 3 days
- •Treatment site has active skin lesion or inflammation
- •Known allergy to skin patch
研究组 & 干预措施
Lidocaine patch
Lidocaine patch local application 1 piece per day for 28 days at back pain area.
干预措施: Lidocaine patch local application (Drug)
Flurbiprofen patch
Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.
干预措施: Flurbiprofen patch local application (Drug)
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: 28 day
Back pain relief effectiveness
次要结局
- Core Outcome Measurement Index (COMI)(0, 7, 14, 21, 28 day)
- Numeric rating scale (NRS)(0, 1, 3, 7, 14, 21 day)
- Oswestry Disability Questionnaire (ODQ)(0, 7, 14, 21, 28 day)
- Brief Pain Inventory-Quality of Life (BPI-QoL)(0, 7, 14, 21, 28 day)
- EQ5D Quality of Life questionnaires Efficacy(0, 7, 14, 21, 28 day)
- Short form-Mcgill Pain Questionnaire (SF-MPQ-2)(0, 7, 14, 21, 28 day)
- Overall Treatment Effect Scale (OTE)(7, 14, 21, 28 day)
- Analgesic consumption(7, 14, 21, 28 day)
- Common Terminology Criteria for Adverse Events (CTCAE)(1, 3, 7, 14, 21, 28 days)
- Skin reaction grade (Assessment of dermal response)(1, 3, 7, 14, 21, 28 days)
研究者
Meng-Huang Wu
Orthopedic specialist
Taipei Medical University Hospital