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临床试验/NCT06957951
NCT06957951已完成不适用

Effectiveness of WBV-Supported Core Training on Pain, Function, and Sleep in Lumbar Disc Herniation: A Randomized Controlled Trial

Gazi University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Pain Intensity (VAS)

研究概览

简要总结

"This randomized controlled trial investigated the effects of conventional physiotherapy, core stabilization exercises, and WBV-supported core stabilization exercises on pain intensity, functional disability, quality of life, and sleep quality in male patients with lumbar disc herniation without neurological deficits."

详细描述

"This study aimed to compare the effects of whole-body vibration (WBV)-supported core exercises, standard core exercises, and conventional physiotherapy on pain, disability, quality of life, and sleep quality among male patients aged 30-50 years with lumbar disc herniation without neurological deficits. Participants were randomly allocated to one of three groups and underwent 12 sessions over 4 weeks. The outcomes assessed were pain (VAS), disability (ODI), quality of life (SF-36), and sleep quality (PSQI)."

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)

盲法说明

Single (Outcomes Assessor)

入排标准

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

入选标准

  • •• Male gender
  • •Age between 30 and 50 years
  • •Diagnosis of lumbar disc herniation (L4-L5 or L5-S1)
  • •No neurological deficits

排除标准

  • •• Prior lumbar surgery
  • •Severe cardiopulmonary or musculoskeletal disorders
  • •Uncontrolled systemic diseases
  • •Participation in another clinical trial

研究组 & 干预措施

Conventional Physiotherapy

Active Comparator

Conventional Physiotherapy including hot pack, TENS, ultrasound, and education.

干预措施: Conventional Physiotherapy (Other)

Core Stabilization Exercises

Active Comparator

Core stabilization exercises added to conventional physiotherapy.

干预措施: Conventional Physiotherapy (Other)

Core Stabilization Exercises

Active Comparator

Core stabilization exercises added to conventional physiotherapy.

干预措施: Core Stabilization Exercises (Behavioral)

WBV-Supported Core Exercises

Experimental

Participants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude ~2 mm).

干预措施: Conventional Physiotherapy (Other)

WBV-Supported Core Exercises

Experimental

Participants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude ~2 mm).

干预措施: WBV-Supported Core Exercises (Behavioral)

结局指标

主要结局

Pain Intensity (VAS)

时间窗: 4 weeks

Change in pain scores measured by Visual Analog Scale.

Functional Disability (ODI)

时间窗: 4 weeks

Change in disability scores measured by Oswestry Disability Index.

Quality of Life (SF-36)

时间窗: 4 weeks

Change in quality of life scores

Sleep Quality (PSQI)

时间窗: 4 weeks

Change in sleep quality scores.

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

Esedullah Akaras

Dr.

Gazi University

研究点 (1)

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