Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Assessing Visual Analog Scale Score Change in Patients
研究概览
简要总结
Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.
详细描述
A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality Index (PSQI).
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 (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcome Assesor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-69
- •Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria
- •Grade 2-3 knee osteoarthritis according to Kellgren-Lawrence grading system
- •VAS-pain score: 4 and above
- •Neuropathic Pain Diagnostic Questionnaire (DN4) score: 4 and above
- •Body mass index value: 40 and below
排除标准
- •A history of trauma or surgical operation in the knee region
- •Diabetes mellitus
- •Fibromyalgia
- •Inflammatory rheumatic disease
- •Central or peripheral neurological disorder
- •Severe cardiac, pulmonary, or malignant disease
- •Invasive treatment for knee last 3 months
研究组 & 干预措施
Duloxetine
33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks
干预措施: Duloxetine (Drug)
Pregabalin
33 patients received 300 mg/day of pregabalin orally for 12 weeks
干预措施: Pregabalin (Drug)
结局指标
主要结局
Assessing Visual Analog Scale Score Change in Patients
时间窗: 0.,4., and 12. weeks
All patients were asked to score the severity of their current knee pain on a 10-cm visual analogue scale (VAS).
Neuropthic Pain Diagnostic Questionnaire (DN4)
时间窗: 0.,4, and 12. weeks
There are 10 questions in the DN-4 including 7 questions related to pain quality and 3 questions that investigate the presence of tactile sensation, pinprick sensation, and allodynia. A total score 4/10 indicates neuropathic pain.
Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients
时间窗: 0., 4. and 12. weeks
The WOMAC consists of 24 questions that assess pain, stiffness, and problems with physical activities. The patient answers all questions on a 5-point Likert-type scale, and the total score ranges from 0 and 96.
次要结局
- Assessing Beck Depression Inventory Score Change in Patients(0., 4. and 12. weeks)
- Assessing Pittsburgh Sleep Quality Index Score Change in Patients(0.,4.,and 12. weeks)
- Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients(0.,4.,and 12. weeks)
- Assesing Beck Anxiety Inventory Score Change in Patients(0.,4.,and 12. weeks)