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

2026年5月10日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

214

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Panqi Wang, MD Candidate
  • 電話番号：+86 188 9690 3118
  • メール：2744237372@qq.com

研究場所

  • 中国
    • Jiangsu
      • Suzhou、Jiangsu、中国、215006
        • 募集
        • The First Affiliated Hospital of Soochow University
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Xiaohong Jin, MD, PHD
        • 副調査官：
          • Panqi Wang, MSc

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：VR-Based Mindfulness Cognitive Therapy Intervention Group
行動：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.
アクティブコンパレータ：Waitlist Usual Care Control Group
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
NRS Pain Intensity
時間枠：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
時間枠：Week 8, Week 26
Global self-reported pain improvement assessed by 7-point Likert scale
Week 8, Week 26
Anxiety (GAD-7)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：Week 8
System usability evaluated by System Usability Scale (SUS)
Week 8
Patient Satisfaction (Intervention group only)
時間枠：Week 8
Patient satisfaction and recommendation willingness rated on 0-10 scale
Week 8

その他の成果指標

結果測定
メジャーの説明
時間枠
Incidence and severity of VR-related adverse events
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The First Affiliated Hospital of Soochow University

協力者

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

捜査官

  • 主任研究者：Xiaohong Jin, MD, PHD、The First Affiliated Hospital of Soochow University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月1日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年5月10日

QC基準を満たした最初の提出物

2026年5月10日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月10日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026306

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いいえ

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