Integration of Virtual Reality and Traditional Acupuncture: From Education to Clinical Practice.
Study Overview
Status
Conditions
Detailed Description
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).
Patients will complete clinic visits during the first 6 weeks (including 6 treatment sessions) and at Week 12 for follow-up, spanning a total study period of 12 weeks. Statistical analysis will be conducted using SPSS software upon data collection. All outcome measures-Vital Signs, FPS-R, FTF, ODI, and HRV-will be assessed immediately before and after each acupuncture session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu-Chen Lee, Ph.D.
- Phone Number: 14564 886-4-22052121
- Email: 005167@tool.caaumed.org.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR-Assisted Acupuncture Group
|
Device: Head-mounted Virtual Reality Display (Oculus Quest 2). Procedure: Participants will wear a VR headset displaying animated visuals of the target acupoint locations and meridian pathways (Hand Three Yang and Foot Three Yang Meridians), while simultaneously receiving actual traditional acupuncture treatment. They will undergo scheduled outcome measurements, including the Faces Pain Scale - Revised (FPS-R), Fingertip-to-Floor (FTF) distance, Oswestry Disability Index (ODI), and Heart Rate Variability (HRV). Acupoints: Yaotuitian (extra point), Quchi (LI11), Shousanli (LI10), Yanglingquan (GB34), Chengshan (BL57), Kunlun (BL60), Taixi (KI3), and Hegu (LI4). Dosage / Schedule: 20 minutes per session, 2 sessions per week for 6 weeks (totaling 12 sessions); target enrollment n=30. |
|
Experimental: Traditional Acupuncture Group
|
Procedure: Participants will receive actual traditional acupuncture treatment alone, without any VR headset or visual imagery display. They will undergo scheduled outcome measurements, including the Faces Pain Scale - Revised (FPS-R), Fingertip-to-Floor (FTF) distance, Oswestry Disability Index (ODI), and Heart Rate Variability (HRV). Acupoints: Yaotuitian (extra point), Quchi (LI11), Shousanli (LI10), Yanglingquan (GB34), Chengshan (BL57), Kunlun (BL60), Taixi (KI3), and Hegu (LI4). Dosage / Schedule: 20 minutes per session, 2 sessions per week for 6 weeks (totaling 12 sessions); target enrollment n=30. |
|
Active Comparator: Conventional Care / Outcome Assessment Only
|
Procedure: Participants will receive no acupuncture interventions (maintaining standard usual care, such as conventional physical therapy or pharmacotherapy). They will undergo scheduled outcome measurements, including the Faces Pain Scale - Revised (FPS-R), Fingertip-to-Floor (FTF) distance, Oswestry Disability Index (ODI), and Heart Rate Variability (HRV). Assessment: Assessed according to the clinical visit timeline; target enrollment n=30. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Finger to Floor test
Time Frame: 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.
|
At baseline, End of treatment(6 weeks), Followed up (12 weeks)
|
|
Faces Pain Scale - Revised (FPS-R)
Time Frame: 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"
|
At baseline, End of treatment(6 weeks), Followed up (12 weeks)
|
|
Heart Rate Variability, HRV
Time Frame: 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
|
At baseline, End of treatment(6 weeks), Followed up (12 weeks)
|
|
Oswestry Disability Index (ODI)
Time Frame: 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).
|
At baseline, End of treatment(6 weeks), Followed up (12 weeks)
|
Collaborators and Investigators
Investigators
- Study Director: Yu-Chen Lee, Ph.D., China Medical University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMUH115-REC1-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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