Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

8. september 2026 oppdatert av: China Medical University Hospital
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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VR-Assisted Acupuncture Group
  1. Device
  2. Procedure
  3. Acupoints
  4. Dosage / Schedule

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.

Eksperimentell: Traditional Acupuncture Group
  1. Procedure
  2. Acupoints
  3. Dosage / Schedule

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.

Aktiv komparator: Conventional Care / Outcome Assessment Only
  1. Procedure
  2. Assessment

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Finger to Floor test
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Yu-Chen Lee, Ph.D., China Medical University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

8. september 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

8. september 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CMUH115-REC1-006

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere