Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Visual analog scale
研究概览
简要总结
Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.
详细描述
The efficacy and safety of the association of celecoxib [a selective cyclooxygenase-2 (COX-2) inhibitor] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms.
We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis.
Each treatment lasted 8 weeks
Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal stenosis
排除标准
- •Koval grade >=3
- •Other musculoskeletal disorders which cause pain on other joint
- •Bleeding risk or ulcer history
- •Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
研究组 & 干预措施
Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
干预措施: Pregabalin 75mg (Drug)
Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
干预措施: Celebrex 200Mg Capsule (Drug)
COX-2 inhibitor
Celecoxib 200mg qd
干预措施: Celebrex 200Mg Capsule (Drug)
结局指标
主要结局
Visual analog scale
时间窗: At 8 weeks
Pain score for low back and lower leg
次要结局
- Pain sensitivity questionnaire (PSQ)(At 8 weeks)
- Oswestry disability index (ODI)(At 8 weeks)
研究者
Ho-Joong Kim
Associate Professor
Seoul National University Bundang Hospital