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临床试验/NCT05838924
NCT05838924已完成不适用

Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial

Cardenal Herrera University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Low back pain

研究概览

简要总结

The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

详细描述

Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
  • Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.

排除标准

  • Presence of spinal tumor.
  • Presence of infection.
  • Presence of fracture.
  • Presence of systemic disease.
  • Presence of fibromyalgia.
  • Presence of cauda equina syndrome.
  • Previous spinal surgery.
  • Presence of musculoskeletal injuries of the lower extremities.

结局指标

主要结局

Low back pain

时间窗: At six weeks

Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.

Range of movement

时间窗: At six weeks

Measured with an electrogoniometer

Disability

时间窗: At six weeks

Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.

次要结局

  • The Quality of life(At six weeks)
  • Physical activity(At six weeks)
  • Catastrophizing(At six weeks)
  • Kinesophobia(At six weeks)
  • Physical capacity(At six weeks)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan F. Lisón Párraga, Dr

Principal Investigator

Cardenal Herrera University

研究点 (1)

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