NCT07737158尚未招募不适用
Efficacy and Safety of Venlafaxine in the Treatment of Non-specific Low Back Pain
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2026年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Change From Baseline in Average Low Back Pain Intensity at Month 3
研究概览
简要总结
Chronic non-specific low back pain is the leading cause of productivity loss and disability worldwide, constituting a major public health challenge. This study aims to systematically evaluate and compare the role of the antidepressant drug Venlafaxine in chronic non-specific low back pain, which is of critical importance for optimising clinical practice and developing precise, individualised treatment regimens.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Diagnosis of chronic nonspecific low back pain, defined as pain located below the costal margin and above the inferior gluteal folds, lasting for more than 3 months, without a specific pathological cause.
- •Moderate to severe pain, defined as a Numerical Rating Scale score of 3 or higher.
- •Able to understand the study procedures and sign written informed consent.
排除标准
- •Low back pain caused by a known specific pathological condition, including but not limited to fracture, malignancy, infection, inflammatory disease, or other identifiable structural or systemic causes.
- •Major comorbidities that may interfere with study outcomes or represent contraindications to the study medication.
- •Current or previous diagnosis of depression, regardless of whether treatment was received.
- •Current or previous use of antidepressant medication.
- •Current use of opioid analgesics.
- •Pregnancy, breastfeeding, or planned pregnancy during the study period.
- •Known allergy, hypersensitivity, or contraindication to toludesvenlafaxine.
- •History of psychosis or other major psychiatric disorders.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
结局指标
主要结局
Change From Baseline in Average Low Back Pain Intensity at Month 3
时间窗: 3 months after randomization
Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
次要结局
- Incidence of Adverse Events(From randomization to 6 months after randomization)
- Change From Baseline in Average Low Back Pain Intensity(Baseline, 1 month, and 6 months after randomization)
- Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire(Baseline, 1 month, 3 months, and 6 months after randomization)
- Global Perceived Recovery(1 month, 3 months, and 6 months after randomization)
- Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L(Baseline, 1 month, 3 months, and 6 months after randomization)
- Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index(Baseline, 1 month, 3 months, and 6 months after randomization)
- Change From Baseline in Back Pain Beliefs Assessed by the Back Beliefs Questionnaire(Baseline, 1 month, 3 months, and 6 months after randomization)
- Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire(Baseline, 1 month, 3 months, and 6 months after randomization)
- Use of Nonsteroidal Anti-inflammatory Drugs(Baseline, 1 month, 3 months, and 6 months after randomization)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital
研究点 (1)
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