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临床试验/NCT07478835
NCT07478835已完成不适用

Effects of Virtual Reality-Assisted Rehabilitation on Pain, Kinesiophobia, Quality of Life, and Supraspinatus Tendon Thickness in Patients With Partial Supraspinatus Tears: A Randomized Controlled Trial

Hitit University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Pain intensity measured by the Numeric Rating Scale (NRS)

研究概览

简要总结

This randomized controlled trial investigated the effects of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears. Partial supraspinatus tears are a common cause of shoulder pain, functional limitation, restricted range of motion, and fear of movement. Conservative rehabilitation is commonly used as first-line treatment, while evidence regarding immersive virtual reality rehabilitation in this patient population remains limited.

Participants were randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups received the same physical therapy modalities, including hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. The control group subsequently performed conventional therapeutic shoulder exercises, whereas the virtual reality group performed approximately equal-duration immersive VR-based exercises instead of the conventional exercise component. Outcomes included pain, shoulder range of motion, disability, kinesiophobia, health-related quality of life, and supraspinatus tendon thickness.

详细描述

This randomized controlled trial investigated the effects of immersive virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears.

Partial supraspinatus tendon tears are a common cause of shoulder pain and functional impairment and may be associated with restricted shoulder range of motion, reduced quality of life, and increased fear of movement. Conservative rehabilitation is commonly used as first-line treatment and typically includes physical therapy modalities together with exercises aimed at restoring shoulder mobility, rotator cuff function, and scapular control.

Virtual reality allows patients to perform repetitive, task-oriented upper-extremity movements within an interactive environment. Such systems may support active participation and provide visual feedback during movement; however, evidence regarding immersive virtual reality rehabilitation specifically in patients with partial supraspinatus tendon tears remains limited.

Participants with MRI-confirmed partial supraspinatus tendon tears were randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups received a standardized physical therapy program consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation.

Following these physical therapy modalities, participants in the control group performed approximately 30 minutes of supervised conventional therapeutic exercises targeting shoulder mobility, stretching, strengthening, and scapular stabilization. Participants in the virtual reality group instead performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise. Thus, the virtual reality intervention replaced the conventional therapeutic exercise component rather than being added as an additional treatment, and the scheduled exercise duration was approximately equivalent between groups.

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

入选标准

  • Aged 18 to 65 years
  • Shoulder pain persisting for more than four weeks
  • Partial supraspinatus tendon tear confirmed by shoulder magnetic resonance imaging

排除标准

  • Physiotherapy treatment within the previous six months
  • Shoulder injection within the previous six months
  • History of tendon repair surgery
  • Communication or cognitive impairment
  • Vertigo, vestibular disorder, or another condition causing balance instability
  • History of epilepsy or seizures
  • Photosensitivity
  • Diagnosed psychiatric condition, including an anxiety disorder or claustrophobia
  • Additional orthopedic condition affecting the same shoulder
  • Neurological, vascular, or cardiac disorder restricting functional capacity
  • Pregnancy or breastfeeding

研究组 & 干预措施

virtual reality group

Experimental

Participants received the same physical therapy modalities as the control group, consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. They subsequently performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise using a Meta Quest Pro headset instead of the conventional therapeutic exercise component. The virtual reality exercise was therefore a replacement rather than an additional treatment.

干预措施: VR-assisted rehabilitation program (Behavioral)

Control Group

Active Comparator

Participants received physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. They subsequently performed approximately 30 minutes of supervised conventional therapeutic shoulder exercises targeting shoulder mobility, stretching, strengthening, and scapular stabilization.

干预措施: Conventional shoulder exercise program (Behavioral)

结局指标

主要结局

Pain intensity measured by the Numeric Rating Scale (NRS)

时间窗: Baseline and after 3 weeks of treatment

Pain intensity at rest and during shoulder movement was assessed separately using an 11-point Numeric Rating Scale, ranging from 0 (no pain) to 10 (the worst pain imaginable). Higher scores indicated greater pain intensity.

次要结局

  • Passive range of motion (ROM) of the affected shoulder(Baseline and after 3 weeks of treatment)
  • Shoulder pain and disability measured using the Shoulder Pain and Disability Index (SPADI)(Baseline and after 3 weeks of treatment)
  • Health-related quality of life measured using the Short Form-36 (SF-36)(Baseline and after 3 weeks of treatment)
  • Kinesiophobia measured using the Tampa Scale of Kinesiophobia(Baseline and after 3 weeks of treatment)
  • Supraspinatus tendon thickness measured using ultrasonography (USG)(Baseline and after 3 weeks of treatment)
  • Shoulder pain and functional impairment were assessed using the Shoulder Pain and Disability Index (SPADI)(Baseline and after 3 weeks of treatment)
  • Health-related quality of life was evaluated using the Short Form-36 (SF-36) questionnaire(Baseline and after 3 weeks of treatment)
  • Fear of movement and reinjury was assessed using the Tampa Scale of Kinesiophobia (TAMPA)(Baseline and after 3 weeks of treatment)
  • The supraspinatus tendon thickness was measured using Ultrasonography(USG)(Baseline and after 3 weeks of treatment)

研究者

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

Pınar Özge Başaran

Principal Investigator

Hitit University

研究点 (1)

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