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.
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.
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).
Parallel
VR-Assisted Acupuncture Group
DeviceDevice: 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.
Traditional Acupuncture Group
Procedure/SurgeryProcedure: 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.
Conventional Care / Outcome Assessment Only
Other interventionProcedure: 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.
Finger to Floor test
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)
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
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)
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).
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This trial is not recruiting at the moment. You can still explore other options:
