Chronic Low Back Pain (cLBP)NCT07816796
Integration of Virtual Reality and Traditional Acupuncture: From Education to Clinical Practice.
A study testing VR-Assisted Acupuncture Group, Traditional Acupuncture Group and Conventional Care / Outcome Assessment Only in people with Chronic Low Back Pain (cLBP), run by China Medical University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Low Back Pain (cLBP)
- What is being tested?
- VR-Assisted Acupuncture Group, Traditional Acupuncture Group and Conventional Care / Outcome Assessment Only
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Chronic Low Back Pain (cLBP)
- Being tested
- VR-Assisted Acupuncture Group, Traditional Acupuncture Group, Conventional Care / Outcome Assessment Only
- Keywords
- Acupuncture, Chinese medicine, Virtual Reality Acupuncture, Chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Assisted Acupuncture GroupDevice
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.
Traditional Acupuncture GroupProcedure or surgery
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.
Conventional Care / Outcome Assessment OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-Assisted Acupuncture Group | Experimental | 1. Device
2. Procedure
3. Acupoints
4. Dosage / Schedule Receives: Device: VR-Assisted Acupuncture Group |
| Traditional Acupuncture Group | Experimental | 1. Procedure
2. Acupoints
3. Dosage / Schedule Receives: Procedure: Traditional Acupuncture Group |
| Conventional Care / Outcome Assessment Only | Active comparator | 1. Procedure
2. Assessment Receives: Other: Conventional Care / Outcome Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, End of treatment(6 weeks), Followed up (12 weeks)
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"
Measured: At baseline, End of treatment(6 weeks), Followed up (12 weeks)
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
Measured: At baseline, End of treatment(6 weeks), Followed up (12 weeks)
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).
Measured: At baseline, End of treatment(6 weeks), Followed up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start8 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomized controlled parallel study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chen Lee, Ph.D., Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816796
- Sponsor's protocol ID
- CMUH115-REC1-006
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No