The Effect of Whole-Body Vibration Exercises Combined With Balneotherapy on Pain, Function, and Sleep Quality in Patients With Chronic Low Back Pain
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
- 3
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This randomized controlled clinical trial aims to investigate the effects of whole-body vibration (WBV) exercises combined with balneotherapy on pain, physical function, sleep quality, and daily activity levels in individuals with chronic low back pain.
A total of 60 volunteers aged 18 to 65 who have been diagnosed with chronic low back pain by a physical medicine and rehabilitation specialist and who meet the eligibility criteria will be included. Participants will be randomly assigned to two groups. Both groups will receive balneotherapy five days a week for three weeks. After balneotherapy, the first group will perform standard stretching, strengthening, and aerobic exercises designed for low back pain. The second group will receive the same exercise program in combination with WBV exercises using a vibration platform. WBV sessions will include static and dynamic exercises with specific frequency and amplitude settings.
All participants will be evaluated at baseline and after three weeks using validated measures, including pain intensity (Visual Analog Scale), spinal mobility (Modified Schober Test), balance and reach (Functional Reach Test), physical performance (Sit-to-Stand and Timed Up and Go Tests), disability (Oswestry Disability Index, Roland-Morris Questionnaire), and sleep quality (Pittsburgh Sleep Quality Index).
The study seeks to determine whether combining WBV with balneotherapy can provide additional benefits over standard exercise alone in managing chronic low back pain.
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
- Double (Participant, 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
- 否
入选标准
- •Voluntary consent to participate in the study
- •Age between 18 and 65 years
- •Having chronic low back pain lasting at least 3 months or recurring at least 3 times per week
- •Diagnosis of chronic low back pain by a physical medicine and rehabilitation specialist
- •Normal neurological examination findings (no abnormal lower extremity reflexes or anesthesia)
排除标准
- •Presence of radicular pain or radiculopathy
- •Spondylolisthesis, spinal stenosis, vertebral infection, or cauda equina syndrome
- •Vertebral fracture, axial spondyloarthritis
- •History of lumbar spine surgery
- •Inflammatory rheumatic disease, psychiatric or neurological disorders
- •Uncontrolled hypertension, decompensated organ failure, or malignancy
- •Pregnancy or breastfeeding
- •Use of systemic steroids in the last 3 months
- •Major trauma or surgery within the past 6 months
- •Receiving physical therapy or physical modalities within the past 6 months
- •Any health condition that prevents participation in balneotherapy or exercise programs
研究组 & 干预措施
Balneotherapy and Whole-Body Vibration Exercise Group
Participants in this group will also receive 20-minute balneotherapy sessions five days per week for three weeks. After a 30-40 minute rest, they will first complete the same standardized exercise program as the first group. Then, they will perform whole-body vibration (WBV) exercises on a vibration platform (Compex Winplate). The WBV session will include static squats, dynamic squats, bridge exercises, dynamic weight shifting, and toe raises, performed at 30-40 Hz frequency and 2-4 mm amplitude for 40-60 seconds per set, with 2 sets per session and 3-minute rest intervals.
干预措施: Whole-Body Vibration Exercise (Behavioral)
Balneotherapy and Standard Exercise Group
Participants in this group will receive 20-minute balneotherapy sessions five days per week for three weeks. Following a 30-40 minute rest, they will perform a standardized exercise program targeting chronic low back pain. The program includes stretching, strengthening, range of motion, and stabilization exercises focused on the lumbar spine, hips, and lower extremities. Exercises will be performed in 2 sets of 8-10 repetitions. Sessions will be supervised by a physiotherapist.
干预措施: Balneotherapy (Behavioral)
Balneotherapy and Whole-Body Vibration Exercise Group
Participants in this group will also receive 20-minute balneotherapy sessions five days per week for three weeks. After a 30-40 minute rest, they will first complete the same standardized exercise program as the first group. Then, they will perform whole-body vibration (WBV) exercises on a vibration platform (Compex Winplate). The WBV session will include static squats, dynamic squats, bridge exercises, dynamic weight shifting, and toe raises, performed at 30-40 Hz frequency and 2-4 mm amplitude for 40-60 seconds per set, with 2 sets per session and 3-minute rest intervals.
干预措施: Balneotherapy (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline and after 3 weeks of intervention
SQI will be used to evaluate subjective sleep quality across 7 components. Higher total scores indicate poorer sleep quality.
Modified Schober Test
时间窗: Baseline and after 3 weeks
Timed Up and Go (TUG) Test
时间窗: Baseline and after 3 weeks
30-Second Chair Stand Test
时间窗: Baseline and after 3 weeks
Functional disability measured by Oswestry Disability Index
时间窗: Baseline and after 3 weeks of intervention
Functional Reach Test
时间窗: Baseline and after 3 weeks
Roland-Morris Disability Questionnaire
时间窗: Baseline and after 3 weeks
次要结局
未报告次要终点
研究者
Selim Mahmut GÜNAY
Asst prof
Mustafa Kemal University