Effects of Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
One of the most prevalent causes of pain on a global scale is chronic musculoskeletal pain. Low back pain is a prevalent manifestation of chronic musculoskeletal pain.
There are a wide vary of no pharmacologic treatment for chronic pain. From a physiotherapy perspective, the chronic pain management should be oriented towards increasing the self-management of people with chronic pain. The management components in question are therapeutic exercise and education.
High-intensity interval training (HIIT) is a novel therapeutic exercise strategy that has been shown to reduce pain and disability in chronic low back pain. It is a hopeful strategy to enhance motivation to treatment. Pain neuroscience education (PNE) has also been demonstrated to enhance pain and disability in chronic low back pain. Finally, virtual reality (VR) has been demonstrated to be effective in the chronic low back pain management.
Despite the benefits mentioned in these three therapies being isolated, there are no studies that have compared VR-based HIIT (VR-HIIT) with PNE in chronic low back pain. The use of these interventions may increase the intervention benefits. The investigators hypothesise that VR-HIIT with PNE can reduce pain intensity, enhance fear of movement and improve motivation for treatment in chronic low back pain. Therefore, the aim of this study is to evaluate the effects of VR-HIIT with PNE in chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years
- •Chronic low back pain
- •Pain intensity ≥ 3 points with the numeric pain rating scale
- •Ability to walk ≥ 15 minutes
- •Wish to participate in the study and sign the informed consent
排除标准
- •Pregnancy
- •Patients with severe comorbidities that interfere with the ability to perform the study
- •People who are currently participating in another study
研究组 & 干预措施
High intensity interval training (HIIT) group
干预措施: High intensity interval training (HIIT) group (Other)
Virtual reality-based high intensity interval training (VR-HIIT) group
干预措施: Virtual reality based high intensity interval training (VR-HIIT) group (Other)
结局指标
主要结局
Pain intensity
时间窗: Baseline, during the intervention and 48-72 hours post-intervention
To assess pain intensity using the Numeric Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater intensity.
Pain pressure threshold
时间窗: Baseline and 48-72 hours post-intervention
To assess pain pressure threshold. The measurement will be taken in the paravertebral and tibialis anterior muscles with the algometer Force One FPIX 50. The measurement points will be lumbar region bilaterally 5 cm from the spinous processes of L3 and L5; and right tibialis anterior, 5 cm below the tibial tuberosity. The assessor will place the algometer perpendicular and applied increasing pressure. until the pressure became painful. The mean of 3 measurements was recorded.
Pain modulation
时间窗: Baseline and 48-72 hours post-intervention
To assess pain modulation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the tibialis anterior muscle and the deltoid muscle. Then the conditioning stimulus will be introduced. A clamp will be placed on the earlobe for 60 seconds. When pain VAS of the earlobe become more than 60 mm, pain pressure threshold will be evaluated again
Fear to movement
时间窗: Baseline and 48-72 hours post-intervention
To assess fear to movement using the TAMPA Scale of Kinesiophobia (TSK). Scores range from 1 (totally disagree) to 4 (totally agree). The final score can range between 11 and 44 points. Higher scores indicate greater perceived fear of movement.
Catastrophizing of pain
时间窗: Baseline and 48-72 hours post-intervention
To assess catastrophizing of pain using the Pain Catastrophizing Scale (PCS). Scores range from 0 (nothing at all) to 4 (all the time). The final score range from 0 to 52. Higher scores indicate greater levels of catastrophism
次要结局
- Pain intensity and interference(Baseline and 48-72 hours post-intervention)
- Pain vigilance and awareness(Baseline and 48-72 hours post-intervention)
- Pain beliefs(Baseline and 48-72 hours post-intervention)
- Health related quality of life(Baseline and 48-72 hours post-intervention)
- Pain self-efficacy(Baseline and 48-72 hours post-intervention)
- Sleep quality(Baseline and 48-72 hours post-intervention)
- Disability(Baseline and 48-72 hours post-intervention)
- Functional status(Baseline and 48-72 hours post-intervention)
- Mobility(Baseline and 48-72 hours post-intervention)
研究者
Irene Torres Sánchez
PhD
Universidad de Granada