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临床试验/NCT06159413
NCT06159413已完成不适用

LUMBAR MULTIFIDUS MUSCLES FUNCTION AMONG PATIENTS WITH LOW BACK PAIN: VIRTUAL REALITY VERSUS STABILIZATION EXERCISES.

University of Hail1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Level of functional impairments

研究概览

简要总结

Abstract:

Background: The multifidus muscle, the most medially located back muscle and the largest muscle that spans the lumbosacral junction serves to provide dynamic stability to the spinal column. Virtual reality and core stabilization exercises are commonly used for balance training in musculoskeletal conditions. The knowledge regarding the effective implementation of these training protocols in patients suffering from chronic low back pain (LBP) is insufficient.

Objective: The purpose of the present study is to investigate the efficacy of virtual reality versus stabilization exercises on lumbar multifidus muscle function among patients with low back pain.

Design: Randomized, double-blinded controlled study. Participants: Sixty LBP participants will be divided into three groups in a 1:1:1 ratio, 20 in each group (control group, stabilizing exercises, and virtual reality rehabilitation system). All three groups received training three days per week throughout the Six-week treatment session.

Outcome measures: Evaluation of pain by the visual analog scale (VAS), Level of functional impairments by Oswestry Disability Index and Accuracy of lumbar repositioning measurement by Biodex system will be measured at baseline and after Six weeks.

详细描述

Introduction:

Low back pain (LBP) is still a significant concern for the public. Health concerns in affluent nations despite advances in our understanding of spinal illnesses. The issue is significant because of its socioeconomic and psychological implications and the shortcomings of many suggested preventive or cure measures (Almazrou et al., 2020; Schmidt et al., 2020). Up to 75% of people will experience low back discomfort at some point with some extent of functional difficulties (De Souza et al., 2019).

With its distinct stabilizing function, the multifidus muscle, which spans the lumbosacral junction and is situated medially in the back, gives the spinal column dynamic stability (Zwambag et al., 2019). It is crucial to remember that people with low back pain may have a multifidus muscle problem, which includes critical structural alterations such as atrophy and the replacement of muscular tissue with fatty infiltrates (Shahidi et al., 2017). A lack of proprioception and abnormal recruitment patterns are two further motor control deficiencies noted (Chua et al., 2022; Shahidi et al., 2023).

Several studies have linked Multifidus muscle atrophy to LBP in both acute and chronic stages (Maas et al., 2018). This muscle loss is not due to atrophy from lack of usage; multifidus activity is reflexively inhibited (Masse-Alarie et al., 2016a). Atrophy of the spinal muscles can lead to instability and recurrent back problems (Massé-Alarie et al., 2016b). Appropriate lumbosacral position sensing depends on the multifidus muscles' muscle spindles. Lower back pain (LBP) sufferers typically have a less accurate and exact sense of their position than healthy individuals. Multifidus muscle atrophy may result in muscle spindle dysfunction, which can limit muscle spindle input and impair segmental stability and spinal proprioception (Crawford et al., 2019; Gabel et al., 2021).

Computer technology, virtual reality (VR), employs sensory feedback to provide users with an experience that mimics real-life activities and events. People can improve their motor abilities in a fashion that mimics the real world by using a three-dimensional virtual environment (Park et al., 2019). Virtual reality systems are well known for their distinctive qualities of interactivity and immersion. Utilizing several sense channels, such as sight, hearing, and touch, requires interaction. The degree of interaction with the virtual environment, on the other hand, is related to immersion (Coburn et al., 2017; Papadopoulos et al., 2021). To influence the cognitive processes involved in motor control, one needs a sense of "degree of presence," or awareness of one's existence in a certain scenario. Virtual reality technology makes the development of interactive training regimens that target various muscles, joints, coordinated movements, or the complete body easier (Levac et al., 2019; Tieri et al., 2018). There is currently a dearth of research on how VR affects the function of the multifidus muscles in people with LBP.

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 (Participant)

盲法说明

Sixty LBP participants will be divided into three groups in a 1:1:1 ratio, 20 in each group (control group, stabilizing exercises, and virtual reality rehabilitation system). All three groups received training three days per week throughout the Six-week treatment session.

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with low back pain.

排除标准

  • •Patients with pain more than 8 according to VAS.
  • •Any joint problems.
  • •Any surgical intervention.

结局指标

主要结局

Level of functional impairments

时间窗: 6 weeks

To assess functional disability, we employed the Oswestry Disability Index. Ten multiple-choice questions about back discomfort and everyday activities are included. Each question has six potential answers and a maximum score of 5. Based on a few chosen statements, the ultimate score is determined.

Accuracy of lumbar repositioning measurement

时间窗: 6 weeks

Knee blocks, leg pads, thigh straps, pelvic brace, lumbar pad, and force application straps will be used to position the person in the Biodex system. The head will be supported on a flexible rest while straps restrained the torso. The spinal range of motion created a neutral spinal posture at 30 degrees lumbar flexion. We asked participants to bend their backs as far as possible to determine the range of motion. For consistency, the dynamometer will be adjusted at zero degrees. Participants will be instructed to recall and replicate a 30° position in a practice trial. We ran this test thrice and calculated the mean deviation each time.

Evaluation of pain

时间窗: 6 weeks

The visual analog scale (VAS) is a 10 cm line with 0 representing no pain and 10 representing the worst pain. It will be used to ask patients to rate how much pain they perceived. They will be told to draw a mark on the line where their level of pain will be.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Raafat Atteya

Assistant Professor

University of Hail

研究点 (1)

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