Effect of Skin Stretching on Pain Reduction During Local Anesthetic Injections: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to investigate the potential analgesic effect of skin stretching during local anesthetic injection in patients with chronic lumbar pain and bilateral lower extremity radiculopathy undergoing selective transforaminal nerve block. This research is based on the hypothesis that mechanical skin stretching can reduce injection-related pain by facilitating the dispersion of the anesthetic agent and decreasing tissue resistance. By comparing the skin stretching technique with the conventional method of local anesthetic administration, this study aims to evaluate differences in pain perception, discomfort, and behavioral pain responses. The ultimate goal is to provide evidence for a simple, non-invasive, and effective intervention that can improve patient comfort and enhance the quality of clinical pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older with chronic low back pain lasting for more than 3 months, accompanied by bilateral lower extremity radiculopathy, who require Selective Transforaminal Epidural Block (STEB).
- •Patients with a Numerical Rating Scale (NRS) score of 5/10 or higher, with pain that affects daily life activities.
排除标准
- •Patients whose pain is influenced by mechanisms other than radiculopathy, such as peripheral neuropathy or myelopathy.
- •Patients with a history of lumbar surgery within the last 6 months, or spinal injection treatment within the last 3 months.
- •Patients with a history of allergy to local anesthetics, steroids, or contrast agents, or those at increased bleeding risk due to anticoagulant use (INR > 1.2).
- •Patients with localized infections, sepsis, uncontrolled diabetes, or hypertension.
- •Patients who are unable to consent or cooperate with the study procedures (e.g., cognitive impairment, severe mental illness).
研究组 & 干预措施
control group
conventional local anesthetic group
干预措施: conventional local anesthetic injection (Procedure)
skin stretching group
skin stretching group for anesthetic local injection
干预措施: skin stetching technique for local anesthetic injection (Procedure)
结局指标
主要结局
Pain score
时间窗: immediately after the local injection
A comparison of pain score between control (conventional local anesthetic method) and skin stretching group using NRS.
次要结局
- unpleasantness score(immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.)
- behavior pain score(immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.)
- soreness around the injection site(immediately after for unpleasantness score, behavior pain score, and 1 month after for soreness, respectively.)