ACTRN12624001184561尚未招募Unknown
Cognitive behavioural therapy-informed virtual reality: a randomised controlled trial evaluating the feasibility and efficacy for pain and disability outcomes in people with persistent low back pain.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Pain[Numerical Pain rating score (0-10) Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ];Kinesiophobia[Tampa Scale of Kinesiophobia Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ];Disability[Oswestry Disability Index Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Low back pain great than or equal to 3 months2.Aged 18-65 years3.At least moderate pain-related fear of movement (greater than or equal to 35 on Tampa Scale of Kinesiophobia)4.At least moderate LBP-related disability (Greater than or equal to 22% on Oswestry Disability Scale)5.Minimum average pain of 4 on 11-point numeric rating scale6.Access to a mobile phone for SMS7.Unobstructed space 2.5m x 2.5m for completing VR gameplay in their home8.Able to mobilise without an aid9.Referred from service (i.e. Musculoskeletal Physiotherapy Screening Clinic; Tess Cramond Pain and Research Centre) for conservative management by member of multidisciplinary team.
排除标准
- •1.Specific diagnosis impacting capacity for forward bending (e.g. unstable spondylolisthesis)2.Current pregnancy3.Severe vertigo4.Severe susceptibility to motion sickness5.Back pain of a non-musculoskeletal cause6.Severe neurological deficit or symptoms (e.g., cauda equina syndrome, myelopathy, or evidence of nerve root compromise)7.Medical conditions contra-indicating physical exercise8.Insufficient understanding of English and inability to follow directions and instructions. 9.Current use of VR for gaming or mindfulness10.Specific pain education delivered by a health professional in previous 6 months11.Previous back surgery
结局指标
主要结局
Pain[Numerical Pain rating score (0-10) Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ];Kinesiophobia[Tampa Scale of Kinesiophobia Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ];Disability[Oswestry Disability Index Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline. ]
次要结局
未报告次要终点
研究者
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