跳至主要内容
临床试验/CTRI/2025/08/092436
CTRI/2025/08/092436尚未招募2/3 期

The Short-Term Effects of Virtual Reality Versus Pain Neuroscience Education Versus Conventional Physiotherapy on Pain, Kinesiophobia, Catastrophizing, and Disability in Patients With Chronic Low Back Pain

Anjumanisha C Engineer1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年8月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
81
试验地点
1
主要终点
1.VAS

研究概览

简要总结

This study addresses the prevailing issue of chronic low back pain (CLBP), which is a leading cause of disability worldwide. Non-specific chronic low back pain (NSCLBP), which lacks a clearly identifiable structural or pathological origin, is particularly challenging due to its multifactorial nature involving both physical and psychological components. Psychological aspects such as kinesiophobia (fear of movement) and pain catastrophizing significantly affect recovery and quality of life. The study aims to compare the short-term effectiveness of three distinct interventions like Virtual Reality (VR), Pain Neuroscience Education (PNE), and Conventional Physiotherapy (CP) in reducing pain intensity, fear of movement, catastrophizing, and disability among NSCLBP patients. This randomized controlled trial involves 81 participants aged between 18 and 50 years who meet specific inclusion criteria. They will be randomly divided into three equal groups: Group A will receives VR-based rehabilitation along with exercises, Group B will receives PNE combined with exercise therapy, and Group C will receives conventional physiotherapy. Outcome measures include the Visual Analog Scale (VAS), Tampa Scale of Kinesiophobia (TSK-17), Pain Catastrophizing Scale (PCS), Oswestry Disability Index (ODI), Pain Pressure Threshold, and lumbar range of motion assessments. Interventions are administered over four weeks, with pre- and post-assessments to evaluate effectiveness at baseline and 4th week. Virtual Reality is used to provide immersive, task-oriented activities that distract attention from pain and promote movement. PNE focuses on educating patients about the neurophysiological basis of pain to reduce fear and maladaptive beliefs. The conventional physiotherapy group follows standard treatments involving strengthening, stretching, and electrotherapy. The expected outcome is that both VR and PNE may yield superior psychological and functional benefits compared to CP. The study also explores the feasibility and acceptability of VR-based therapy in Indian clinical settings. By comparing these three approaches, this research aims to identify the most effective method for managing NSCLBP and contribute to evidence-based clinical decision-making.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Subjects having low back pain more than 12 weeks or 3months ( Non specific) 2) Age group of 18 to 50 years 3) TSK-17 score equal or greater than 17 4) PCS equal or greater than 30 5) VAS equal or greater than 3.

排除标准

  • Suspected spinal pathology like malignancies, Unhealed vertebral fractures, ankylosing spondylitis, Inflammatory arthritis, Cauda equina syndrome, Spondylolisthesis.
  • Pregnancy.
  • Patients with vision, speech and auditory disorders.
  • Involvement of other systems or multiple systems issues.
  • Unwilling to participate voluntarily.

结局指标

主要结局

1.VAS

时间窗: 1.VAS (baseline and 4th week) | 2.TAMPA Scale (baseline and 4th week) | 3.Pain Catastrophizing scale (baseline and 4th week) | 4.Pain Pressure Threshold (baseline and 4th week) | 5.Oswestry Disability Index (baseline and 4th week)

2.TAMPA Scale

时间窗: 1.VAS (baseline and 4th week) | 2.TAMPA Scale (baseline and 4th week) | 3.Pain Catastrophizing scale (baseline and 4th week) | 4.Pain Pressure Threshold (baseline and 4th week) | 5.Oswestry Disability Index (baseline and 4th week)

3.Pain Catastrophizing scale

时间窗: 1.VAS (baseline and 4th week) | 2.TAMPA Scale (baseline and 4th week) | 3.Pain Catastrophizing scale (baseline and 4th week) | 4.Pain Pressure Threshold (baseline and 4th week) | 5.Oswestry Disability Index (baseline and 4th week)

4.Pain Pressure Threshold

时间窗: 1.VAS (baseline and 4th week) | 2.TAMPA Scale (baseline and 4th week) | 3.Pain Catastrophizing scale (baseline and 4th week) | 4.Pain Pressure Threshold (baseline and 4th week) | 5.Oswestry Disability Index (baseline and 4th week)

5.Oswestry Disability Index

时间窗: 1.VAS (baseline and 4th week) | 2.TAMPA Scale (baseline and 4th week) | 3.Pain Catastrophizing scale (baseline and 4th week) | 4.Pain Pressure Threshold (baseline and 4th week) | 5.Oswestry Disability Index (baseline and 4th week)

次要结局

  • Lumbar Range of Motion(baseline and 4th week)

研究者

发起方
Anjumanisha C Engineer
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjumanisha C Engineer

SDM College of physiotherapy

研究点 (1)

Loading locations...

相似试验