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临床试验/NCT07816796
NCT07816796尚未招募不适用

Integration of Virtual Reality and Traditional Acupuncture: From Education to Clinical Practice.

China Medical University Hospital0 个研究点目标入组 90 人开始时间: 2026年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Finger to Floor test

研究概览

简要总结

This research project aims to develop and validate whether a "VR-assisted traditional acupuncture therapy model" provides superior pain relief and functional improvement compared to acupuncture alone.

详细描述

Chronic low back pain (cLBP) is one of the leading causes of disability and medical resource consumption worldwide, frequently disrupting patients' daily lives and work efficiency due to pain and restricted mobility. While traditional acupuncture has demonstrated clear efficacy in treating low back pain, patients in clinical settings often lack a clear understanding of the anatomical locations of the targeted acupoints and the needle insertion process. This lack of insight leads to reduced engagement in their treatment, which may, in turn, negatively affect treatment compliance and overall therapeutic outcomes.

In recent years, Virtual Reality (VR) technology has gained momentum in the field of pain management, utilizing visual immersion to enhance patient engagement and redirect attention. However, few studies to date have explored the application of modern VR technology within traditional Chinese medicine. Furthermore, existing research predominantly focuses on indirect therapeutic modes such as pain distraction or imagery therapy, rarely integrating VR directly with traditional acupuncture treatment itself.

Based on previous literature reviews and systematic reviews, acupuncturists select different acupuncture treatment protocols based on clinical experience, resulting in significant variation in acupoint selection across studies. Furthermore, because the experimental group must wear a virtual reality headset, a prone position is less feasible. Under this project, the study includes an Experimental Group 1 (Virtual Reality Acupuncture + Traditional Acupuncture), an Experimental Group 2 (Traditional Acupuncture), and a Control Group (Usual Conventional Physical Therapy or Medication Management).

Randomization will occur after baseline assessments and final eligibility confirmation. Participants will be randomly assigned in a 1:1:1 ratio to Experimental Group 1, Experimental Group 2, or the Control Group. The randomization sequence will utilize block randomization with variable block sizes of 4 and 6 to ensure allocation balance and minimize predictability. An independent biostatistician not involved in recruitment, assessment, or intervention procedures will generate the sequence.

The trial will evaluate Vital Signs (body temperature, blood pressure, pulse rate), Faces Pain Scale - Revised (FPS-R), Fingertip-to-Floor (FTF) distance, Oswestry Disability Index (ODI), and Heart Rate Variability (HRV).

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 (Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects presenting with low back pain as their chief complaint.
  • Individuals aged 20 years or older.
  • Baseline pain score of at least 4 on a 0-10 rating scale (e.g., Numeric Rating Scale, NRS).
  • Participants who provide signed informed consent and demonstrate willingness to adhere to all study procedures.

排除标准

  • Refusal to sign the informed consent form.
  • Cognitive or language impairment that hinders effective communication.
  • Inability to tolerate virtual reality (VR) application (e.g., severe motion sickness or cybersickness).
  • Specific underlying causes or pathologies of back pain (e.g., malignancy, spinal fracture, or active infection).
  • Pregnancy.
  • Severe cardiopulmonary disease.
  • History of prior spinal or back surgery.

研究组 & 干预措施

VR-Assisted Acupuncture Group

Experimental
  1. Device
  2. Procedure
  3. Acupoints
  4. Dosage / Schedule

干预措施: VR-Assisted Acupuncture Group (Device)

Traditional Acupuncture Group

Experimental
  1. Procedure
  2. Acupoints
  3. Dosage / Schedule

干预措施: Traditional Acupuncture Group (Procedure)

Conventional Care / Outcome Assessment Only

Active Comparator
  1. Procedure
  2. Assessment

干预措施: Conventional Care / Outcome Assessment Only (Other)

结局指标

主要结局

Finger to Floor test

时间窗: At baseline, End of treatment(6 weeks), Followed up (12 weeks)

The outcome measure is recorded as the vertical distance (in cm) from the tip of the middle finger to the floor.

Faces Pain Scale - Revised (FPS-R)

时间窗: At baseline, End of treatment(6 weeks), Followed up (12 weeks)

The scale consists of six cartoon faces ranging from a neutral expression (score 0 = "no pain") to a face showing severe distress (score 10 = "very much pain"

Heart Rate Variability, HRV

时间窗: At baseline, End of treatment(6 weeks), Followed up (12 weeks)

Primary outcome measures included SDNN and RMSSD for time-domain parameters, and LF, HF, and the LF/HF ratio for frequency-domain parameters

Oswestry Disability Index (ODI)

时间窗: At baseline, End of treatment(6 weeks), Followed up (12 weeks)

The ODI consists of 10 items scored from 0 to 5, yielding a raw score range of 0 to 50 points. The raw score is converted into a percentage score ranging from 0% to 100%. A score of 0% to 20% represents the normal to minimal disability range, whereas a score greater than 20% indicates clinically significant functional impairment (21-40%: moderate; 41-60%: severe; 61-80%: crippling; 81-100%: bed-bound).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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