Comparison of Thread Embedding Acupuncture at the First Lumbar EX-B2 Point With Sham Thread Embedding Acupuncture on Acute Pain and Quality of Life After Laparoscopic Living Donor Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Visual Analogue Scale)
研究概览
简要总结
This randomized, double-blind controlled study aims to evaluate the effectiveness of thread implantation acupuncture at EX-B2 L1 in reducing postoperative pain and improving quality of life in patients undergoing laparoscopic living donor nephrectomy. Thirty-four participants will be randomly assigned to receive either thread implantation acupuncture with polydioxanone (PDO) thread at EX-B2 L1 plus standard postoperative therapy or sham thread implantation acupuncture without thread insertion plus the same standard therapy. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and quality of life with the Short-Form 36 (SF-36). The study seeks to determine whether thread implantation acupuncture provides additional analgesic and quality-of-life benefits beyond standard postoperative care.
详细描述
Laparoscopic donor nephrectomy is the preferred technique for kidney donation due to its minimally invasive nature and faster recovery. However, postoperative pain and decreased quality of life remain significant issues. Excessive reliance on pharmacological analgesia can lead to adverse effects such as hepatotoxicity and gastrointestinal symptoms.
Thread implantation acupuncture involves inserting a biodegradable polydioxanone (PDO) thread into acupuncture points to provide prolonged stimulation. The EX-B2 (L1) point has been shown to modulate lumbar innervation and may help reduce nociceptive signaling associated with postoperative pain.
This double-blind randomized controlled trial compares the analgesic and quality-of-life outcomes between patients receiving thread implantation acupuncture at EX-B2 (L1) plus standard therapy and those receiving sham thread implantation acupuncture plus standard therapy. Pain intensity (VAS) will be measured pre-intervention (Day 0), then at postoperative Days 1, 2, 3, and 14. Quality of life (SF-36) will be evaluated at Day 0 and Day 14. The results are expected to strengthen evidence for thread implantation acupuncture as an adjunctive therapy for acute postoperative pain management and recovery after laparoscopic donor nephrectomy.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living kidney donors scheduled to undergo laparoscopic living donor nephrectomy.
- •Aged 21-60 years.
- •Willing to participate and able to sign written informed consent
排除标准
- •Hypersensitivity to thread-embedding acupuncture (TEA).
- •History of keloid formation or tendency to develop keloids.
- •Skin disorders at or near the planned TEA insertion sites.
- •Neurological abnormalities or lower-limb deficits on physical examination.
- •History of spinal surgery or scheduled for spinal surgery within the next 7 months.
- •Scoliosis based on clinical examination.
- •Other causes of low back pain, such as inflammatory spondylitis, spinal infection, or tumor.
- •Planning to become pregnant within 7 months after LNDH.
- •Body Mass Index (BMI) < 18 kg/m².
- •Uncontrolled diabetes mellitus.
研究组 & 干预措施
Intervention Group
Thread implantation acupuncture
干预措施: Thread implantation acupuncture (Device)
Control Group
Sham thread implantation acupuncture
干预措施: Sham thread implantation acupuncture (Device)
结局指标
主要结局
Change in Pain Intensity (Visual Analogue Scale)
时间窗: From baseline to postoperative Day 14
Visual Analogue Scale (0-100 mm) measured at Day 0 (baseline), Day 1, 2, 3, and 14 post-surgery.
次要结局
- Change in Quality of Life (Short Form-36)(Baseline and Day 14.)
- Analgesic Use(Day 0-14.)
- Adverse Events Adverse Events Adverse Events(Up to Day 14)
研究者
Salman Matoaya Bustan
Principal Investigator
Indonesia University