Assessing the Efficacy of Imagined Acupuncture for Postoperative Acute Pain Management in Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain Scores (VAS)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether imagined acupuncture can reduce postoperative acute pain in adult patients undergoing spinal surgery. The main questions it aims to answer are:
Does video-guided imagined acupuncture improve postoperative pain control?
Does the intervention reduce opioid consumption and improve functional recovery in the immediate postoperative period?
Researchers will compare the imagined acupuncture group to the control education video group to see if imagery-based intervention leads to better pain outcomes and reduced analgesic use.
Participants will:
Watch a 30-minute video once daily for 7 consecutive days after surgery
Complete pain and function assessments during the hospital stay and postoperative follow-up
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing 1- to 2-level primary spine surgery
- •Aged 18 years or older
- •Willing and able to receive postoperative imagined acupuncture (VGAIT)
- •Able to provide written informed consent
排除标准
- •Undergoing revision surgery or procedures involving more than 3 spinal levels
- •History of prior spinal surgery
- •Intraoperative complications likely to interfere with postoperative pain assessment
- •Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication
- •Pregnant or breastfeeding
- •Unable to cooperate with treatment or pain assessments Individuals with uncorrectable vision impairment that would interfere with viewing study videos or completing study questionnaires.
研究组 & 干预措施
Group 1: Imagined Acupuncture Intervention
Participants assigned to Group 1 will receive standard postoperative care and a daily VGAIT session once per day for seven consecutive days following surgery. Each session will last approximately 30 minutes and will be guided by a standardized video designed to induce acupuncture imagery and mental engagement. VGAIT will be administered at the same time each day (e.g., 9:00 AM ± 30 minutes). VAS and ODI assessments will be administered following the completion of the video session. The initial video session will be administered once the patient has fully regained consciousness in the post-anesthesia care unit (PACU) following surgery.
干预措施: video-guided acupuncture imagery treatment (VGAIT) (Other)
Group 2: Education video
Participants in the control group will receive standard postoperative care and Education video without any simulated acupuncture intervention. VAS and ODI assessments will be conducted at the same intervals as in Group 1 for consistency and comparison.
干预措施: Education video (Other)
结局指标
主要结局
Pain Scores (VAS)
时间窗: During the first postoperative week (Days 0-6)
Pain intensity will be assessed using the Visual Analog Scale (VAS) daily, including VAS at rest, VAS on movement
2) Functional Scores (ODI)
时间窗: On postoperative Day6
Functional status will be evaluated using the Oswestry Disability Index (ODI)
3) Rescue Opioid Consumption
时间窗: On postoperative Day6
The total amount of rescue opioid medication used during the first postoperative week will be recorded in milligrams (oral and intravenous)
次要结局
- 1) Time to First Rescue Analgesia(On postoperative Day6)
- 4) Adverse Effects(On postoperative Day6)
- 2) Total Analgesic Consumption(On postoperative Day6)
- 3) Length of Hospital Stay(On postoperative Day6)
- 5) Additional Assessment Tools(On postoperative Day6)
研究者
Jingping Wang, MD, Ph.D.
Associate Professor Staff Anesthesiologist & Pain Physician
Massachusetts General Hospital