Comparing effectiveness and safety of Pregabalin plus Nortriptyline versus Pregabalin plus Duloxetine in patients of chronic low back pain A Randomized Controlled Trial

Dr Vignesh Kumar1 个研究点分布在 1 个国家目标入组 76 人开始时间: 2026年3月2日最近更新: 2026年2月19日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 76
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will be a prospective single centered randomized open label parallel-group control trial comparing effectiveness and safety of Pregabalin plus Nortriptyline versus Pregabalin plus Duloxetine in patients of chronic low back pain.Primary Outcome is Responder Rate greator than or equal to 30 percent reduction in pain intensity using VAS at baseline 4 weeks and 12 weeks.The Secondary Outcome is to Compare functional improvement measured by the Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire RMDQ from baseline to 12 weeks and To assess safety based on adverse effects associated with above mentioned drugs.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Adults aged 18–60 years Patients clinically diagnosed with chronic low back pain persisting for greator than or equal to 3 months VAS score greator than or equal to 5 out of 10 at baseline No specific structural cause of low back pain on imaging examples like no fracture or infection or malignancy Willingness to participate and provide written informed consent Patient refractory to NSAIDS and opioids for more than 3 months and pregabalin alone.

排除标准

•Specific pathological causes of back pain such as infection or malignancy or fracture or rheumatoid arthritis or seronegative arthritis or spinal tumors or vascular malformations History of spinal surgery or severe neurological deficit or cauda equina syndrome Pregnancy or lactation Uncontrolled comorbidities such as cardiac disorders advanced diabetes mellitus hypertension chronic kidney disease chronic liver disease History of depression or psychiatric illness requiring antidepressant treatment in the past 6 months.

研究者

发起方

Dr Vignesh Kumar

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Dr Anna Javed

All India Institute Of Medical Sciences vijaypur jammu 184120

研究点 (1)

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