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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Expérimental: 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.

Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Finger to Floor test
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Yu-Chen Lee, Ph.D., China Medical University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 septembre 2026

Achèvement primaire (Estimé)

31 juillet 2027

Achèvement de l'étude (Estimé)

31 juillet 2027

Dates d'inscription aux études

Première soumission

8 septembre 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

14 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • CMUH115-REC1-006

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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