NCT05572931已完成不适用
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery: a Single-blinded Randomized, Control Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- The total dosage of analgesic drug
研究概览
简要总结
The goal of this clinical trial is to evaluate Fu's Subcutaneous Needling (FSN) in postoperative pain in patients with Lumbar Spine Surgery (LSS). The main questions it aims to answer are:
- Is FSN effective for postoperative pain?
- Dose FSN decrease the tissue hardness after LSS?
- Dose FSN have the effect of anti-inflammatory after LSS?
Participants will receive routine analgesic and FSN after LSS. Researchers will compare Sham group to see if FSN being effective for postoperative pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pain and neurological symptoms are caused by degeneration of the spine (L1-S1) and require surgery.
- •One hour after lumbar spine surgery (evaluated after returning to the ward from the recovery room) Visual analogue scale (VAS) score ≥ 5 points
- •After being explained, join the trial voluntarily and sign the subject's consent form.
排除标准
- •Pain caused by acute trauma.
- •major diseases such as heart and lung failure, cancer, chronic kidney disease.
- •psychiatric disorder.
- •History of substance abuse.
- •A history of spinal surgery.
- •Refused sign the consent form.
结局指标
主要结局
The total dosage of analgesic drug
时间窗: The amount of intravenous opioid drug (Pethidine 50mg/vail) within 72 hours after surgery.
opioid drug (Pethidine 50mg/vail)
Change of Taiwanese version of the Brief Pain Inventory (BPI-T) Short Form
时间窗: Change from Baseline BPI-T at the 1st、24th、48th、72nd hour after surgery.
BPI-T Short Form
次要结局
- Change of Blood serum TNF-α(Change from Baseline TNF-α at the 24th, 72nd hour, 1st month after surgery.)
- Change of Tissue hardness (TH)(Change from Baseline TH at the 1st、24th、48th、72nd hour after surgery.)
- Change of Blood serum C-reactive protein (CRP)(Change from Baseline CRP at the 24th, 72nd hour, 1st month after surgery.)
- Change of Blood serum IL-1ẞ、IL-2、IL-6(Change from Baseline IL-1ẞ、IL-2、IL-6 at the 24th, 72nd hour, 1st month after surgery.)
研究者
Chih-Ying Wu
Attending physician
China Medical University Hospital
研究点 (2)
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