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Effect of VR-MBCT in Chronic Nonspecific Low Back Pain (VR-MBCT-CNLBP)

10. Mai 2026 aktualisiert von: The First Affiliated Hospital of Soochow University

Effect of Virtual Reality-Based Mindfulness-Based Cognitive Therapy in Patients With Chronic Nonspecific Low Back Pain: Protocol for a Prospective, Multi-Center, Open-Label Randomized Controlled Trial

This is a multi-center, prospective, open-label randomized controlled trial evaluating the efficacy and safety of virtual reality-based mindfulness-based cognitive therapy (VR-MBCT) as an adjunct to usual care in adults with chronic nonspecific low back pain (CNLBP). A total of 214 participants aged 20-70 years with pain duration ≥3 months and average back pain bothersomeness ≥4 (0-10 scale) will be enrolled from three hospitals in China and randomized 1:1 to an 8-week VR-MBCT intervention group or a waitlist usual care control group. The co-primary outcomes are the proportions of patients achieving ≥30% improvement from baseline in Oswestry Disability Index (ODI) and self-rated back pain bothersomeness at week 8. Secondary outcomes include pain intensity (NRS), global improvement, anxiety (GAD-7), depression (PHQ-9), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity (WPAI-GH), treatment use, system usability (SUS), and patient satisfaction. Safety will be monitored for VR-related adverse events. Assessments will be performed at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Data will be analyzed following the intention-to-treat principle using mixed-effects models and per-protocol analyses.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Chronic nonspecific low back pain (CNLBP) is a leading global cause of disability, yet conventional treatments often focus on structural damage and neglect cognitive, emotional, and behavioral dimensions. Mindfulness-based cognitive therapy (MBCT) is effective for chronic pain but limited by therapist resources and low adherence. Virtual reality (VR) provides an immersive, standardized platform to improve treatment fidelity, engagement, and scalability. This multi-center randomized controlled trial investigates a tailored 8-week VR-MBCT intervention for CNLBP.

The intervention group receives a hybrid VR-MBCT program consisting of 1 weekly in-clinic VR session (approximately 30 minutes) plus at least 3 home-based audio practice sessions (20-30 minutes per session) for 8 weeks. The progressive curriculum includes automatic pilot and awareness, body scan, mindful movement, graded exposure, responding versus reacting, cognitive defusion, self-compassion, relapse prevention, self-care, and real-world transfer training. The control group receives usual medical care only during the 8-week study period and will be offered the same VR-MBCT intervention after completing the 26-week follow-up.

Outcome assessments are conducted at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Co-primary outcomes are the proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) and back pain bothersomeness (0-10 scale) at week 8. Secondary outcomes include pain intensity (NRS), global improvement, depression (PHQ-9), anxiety (GAD-7), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity and activity impairment (WPAI-GH), and use of concomitant treatments. System usability scale (SUS) and patient satisfaction are assessed in the intervention group only. Safety assessments include monitoring and grading of VR-related adverse events such as dizziness, nausea, eye fatigue, headache, and falls at each contact.

Randomization is performed using a computer-generated sequence with 1:1 allocation, stratified by sex and pain duration (<2 years versus ≥2 years). Outcome assessors and statisticians are blinded to group assignment. Data management follows Good Clinical Practice (GCP) with double-entry verification and independent monitoring. This study will provide evidence for VR-MBCT as a scalable, standardized, non-pharmacological adjunctive intervention for CNLBP.

Studientyp

Interventionell

Einschreibung (Geschätzt)

214

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Panqi Wang, MD Candidate
  • Telefonnummer: +86 188 9690 3118
  • E-Mail: 2744237372@qq.com

Studienorte

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Rekrutierung
        • The First Affiliated Hospital of Soochow University
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Xiaohong Jin, MD, PHD
        • Unterermittler:
          • Panqi Wang, MSc

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Patients who meet the following criteria will be included:

  1. Diagnosed with CNLBP according to standard criteria (3), with pain duration ≥3 months.
  2. Aged 20-70 years (inclusive), regardless of sex.
  3. Average self-reported back pain bothersomeness ≥4(scale, 0-10) in the past week.
  4. Provided informed consent and family members will be informed of the study as support persons.

Exclusion Criteria:

  1. Coexisting pain conditions that may interfere with the assessment of CNLBP
  2. Severe neurological or psychiatric disorders (e.g., unstable epilepsy, psychosis, dementia)
  3. Severe psychiatric comorbidities (e.g., active suicidal ideation, severe depression requiring antidepressant medication)
  4. History of substance abuse (including alcohol or drugs) in the past year
  5. History of accidents or injuries related to back pain in the past year
  6. Severe visual impairment, vertigo, or history of VR-induced motion sickness precluding safe VR use
  7. Inability to communicate effectively to express subjective feelings.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: VR-Based Mindfulness Cognitive Therapy Intervention Group
Verhalten: Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)
Participants in the intervention group will receive an 8-week VR-based telerehabilitation program integrating mindfulness-based cognitive therapy (MBCT), pain neuroscience education (PNE), and graded exposure principles, specifically designed for chronic non-specific low back pain (CNLBP) besides usual clinical care. The program will be delivered through a VR-MR system co-developed by the research team and a technology company in Hangzhou. The system will comprise a PICO Ultra VR-MR headset for immersive mixed-reality experiences and a DM-TG01A motion capture camera for real-time tracking of participant movements and postures. All equipment will be provided to participants at no cost.
Aktiver Komparator: Waitlist Usual Care Control Group
Sonstiges: Waitlist Usual Care Control Group
The control group will receive standard clinical care (including pharmacological treatment, physical therapy, and home exercise as usual) without any structured VR training for the initial 8-week study period. After completing the 6-month follow-up assessment, control group participants will be offered the same 8-week VR-MBCT program based on their choices.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8
Zeitfenster: Baseline, Week 8
Functional disability assessed by the validated Oswestry Disability Index (ODI, score range 0-100%). Treatment responder defined as achieving a minimum clinically important improvement of ≥30% reduction from baseline at week 8.
Baseline, Week 8
Proportion of participants achieving ≥30% improvement in self-reported back pain bothersomeness (0-10 scale) from baseline at Week 8
Zeitfenster: Baseline, Week 8
Back pain bothersomeness rated on a 0-10 scale (0 = no bother, 10 = worst bothersomeness). Responder defined as ≥30% score reduction from baseline at week 8.
Baseline, Week 8

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NRS Pain Intensity
Zeitfenster: Baseline, Week 8, Week 26
Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)
Baseline, Week 8, Week 26
Global Pain Improvement
Zeitfenster: Week 8, Week 26
Global self-reported pain improvement assessed by 7-point Likert scale
Week 8, Week 26
Anxiety (GAD-7)
Zeitfenster: Baseline, Week 8, Week 26
Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)
Baseline, Week 8, Week 26
Depression (PHQ-9)
Zeitfenster: Baseline, Week 8, Week 26
Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)
Baseline, Week 8, Week 26
Physical Activity (IPAQ-SF)
Zeitfenster: Baseline, Week 8, Week 26
Change in physical activity level assessed by International Physical Activity Questionnaire Short Form (IPAQ-SF)
Baseline, Week 8, Week 26
Sleep Quality (SQS)
Zeitfenster: Baseline, Week 8, Week 26
Change in overall sleep quality assessed by Single-item Sleep Quality Scale (SQS)
Baseline, Week 8, Week 26
Fear-Avoidance Beliefs (FABQ-PA)
Zeitfenster: Baseline, Week 8, Week 26
Change in fear-avoidance beliefs toward physical activity assessed by FABQ-PA
Baseline, Week 8, Week 26
Pain Catastrophizing (PCS)
Zeitfenster: Baseline, Week 8, Week 26
Change in pain catastrophizing level assessed by Pain Catastrophizing Scale(PCS)
Baseline, Week 8, Week 26
Work Productivity (WPAI-GH)
Zeitfenster: Baseline, Week 8, Week 26
Change in work productivity and activity impairment assessed by Work Productivity and Activity Impairment General Health (WPAI-GH)
Baseline, Week 8, Week 26
Concomitant Treatment Use
Zeitfenster: Baseline, Week 8, Week 26
Changes in the use of additional treatments and opioid medication for low back pain
Baseline, Week 8, Week 26
System Usability (SUS, Intervention group only)
Zeitfenster: Week 8
System usability evaluated by System Usability Scale (SUS)
Week 8
Patient Satisfaction (Intervention group only)
Zeitfenster: Week 8
Patient satisfaction and recommendation willingness rated on 0-10 scale
Week 8

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence and severity of VR-related adverse events
Zeitfenster: Immediately after each VR session, Week 4, Week 8, Week 26
VR-related adverse events (including dizziness, nausea, eye strain, headache, cold sweat, and anxiety) will be actively monitored immediately after each VR training session using a 4-point severity scale (0=absent, 1=mild, 2=moderate, 3=severe). All adverse events, including non-VR-related events, will also be collected and reviewed at scheduled follow-up visits (Week 4, Week 8, Week 26).
Immediately after each VR session, Week 4, Week 8, Week 26

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The First Affiliated Hospital of Soochow University

Mitarbeiter

Sir Run Run Shaw Hospital
The Fourth Affiliated Hospital of Soochow University

Ermittler

  • Hauptermittler: Xiaohong Jin, MD, PHD, The First Affiliated Hospital of Soochow University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

10. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026306

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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