Effects of Daytime and Evening Rehabilitation Programs on Sleep Quality and Daytime Sleepiness in Patients With Lumbar Disc Herniation at High Risk for Obstructive Sleep Apnea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Daytime Sleepiness (Epworth Sleepiness Scale - ESS)
研究概览
简要总结
Lumbar disc herniation is a common musculoskeletal condition that negatively affects quality of life, physical function, and daily activities. Previous studies have shown that individuals with lumbar disc herniation often experience poor sleep quality, which is closely related to pain severity and functional limitations. In addition, a bidirectional relationship exists between chronic pain and sleep disturbances, where poor sleep can increase pain perception, and pain can further impair sleep.
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder associated with reduced sleep quality, daytime dysfunction, and adverse health outcomes. The STOP-Bang questionnaire (Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, and Gender) is a widely used and practical screening tool to identify individuals at high risk for OSA in clinical settings.
Physiotherapy and rehabilitation programs are commonly used in the conservative management of lumbar disc herniation and have been shown to improve pain and functional outcomes. However, the effect of the timing of rehabilitation (daytime versus evening) on sleep-related outcomes has not been sufficiently investigated. Considering that circadian rhythms influence pain perception, physiological processes, and sleep regulation, the timing of rehabilitation interventions may play an important role in clinical outcomes.
Therefore, this randomized controlled trial aims to investigate the effects of daytime versus evening rehabilitation programs on sleep quality and daytime sleepiness in patients with lumbar disc herniation who are at high risk for obstructive sleep apnea.
详细描述
Lumbar disc herniation is a common musculoskeletal condition associated with pain, functional limitations, and impaired sleep quality. Previous evidence suggests a bidirectional relationship between pain and sleep disturbances, where poor sleep may exacerbate pain perception and functional disability. Obstructive sleep apnea (OSA), a prevalent sleep-related breathing disorder, may further contribute to impaired sleep quality and daytime dysfunction in these patients.
Although physiotherapy and rehabilitation are widely used in the conservative management of lumbar disc herniation, the impact of the timing of rehabilitation interventions on sleep-related outcomes remains unclear. Circadian rhythms are known to influence physiological processes, pain perception, and sleep regulation, suggesting that the timing of rehabilitation may affect clinical outcomes.
This study is designed as a randomized, parallel-group controlled trial. Participants with lumbar disc herniation and high risk for OSA (STOP-Bang score >4) will be randomly assigned to receive the same rehabilitation program either during daytime or evening sessions. The intervention will include electrotherapy modalities and a structured exercise program focusing on motor control and core stabilization.
Primary outcomes include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) and daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS). Secondary outcomes include pain intensity, functional disability, and physical performance.
The findings of this study are expected to provide evidence on whether the timing of rehabilitation interventions influences sleep-related outcomes and may contribute to optimizing treatment strategies in clinical practice.
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
- None
盲法说明
This study is open-label. Due to the nature of the intervention (rehabilitation timing), blinding of participants and care providers is not feasible.
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
- •Individuals aged 18-65 years
- •High risk for obstructive sleep apnea, defined as a score >4 on the STOP-Bang questionnaire (Snoring, Tiredness, Observed apnea, high blood pressure, Body mass index, Age, Neck circumference, and Gender)
- •Presence of lumbar disc herniation (bulging, protrusion, or extrusion) at L1-S1 levels confirmed by magnetic resonance imaging (MRI)
- •Chronic low back pain lasting at least 3 months with clinical symptoms consistent with imaging findings
- •Mild to moderate radicular symptoms For participants over 55 years of age: single-level or dominant-level protrusion or extrusion-type disc herniation to minimize confounding effects of multilevel degeneration
- •Pain intensity ≥4 on the Visual Analog Scale (VAS) within the last week
- •Ability to participate regularly in the physiotherapy and rehabilitation program
- •Willingness to provide written informed consent
排除标准
- •Presence of sequestrated disc herniation or cauda equina compression confirmed by magnetic resonance imaging (MRI)
- •Progressive motor deficit or significant muscle weakness
- •Indication for urgent surgical intervention
- •History of previous lumbar spine surgery
- •Low back pain due to specific causes (e.g., spinal tumor, infection such as spondylodiscitis, inflammatory rheumatic diseases, or traumatic fracture)
- •Previous use of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) therapy
- •Shift work or irregular sleep patterns
- •Major changes in sleep medication within the last 4 weeks
- •Contraindications to electrotherapy (e.g., pacemaker or implanted electronic devices, suspected malignancy, sensory loss in the treatment area, open wounds, or infection)
- •Cardiopulmonary conditions that contraindicate exercise
- •Uncontrolled hypertension or advanced heart failure
- •Pregnancy
- •Severe psychiatric disorders or cognitive impairment
- •Neurological disorders (e.g., multiple sclerosis, stroke sequelae)
- •Epidural or facet joint injection within the last 3 months
- •Diagnosed severe obesity hypoventilation syndrome or severe chronic obstructive pulmonary disease (COPD)
- •Refusal to provide informed consent
研究组 & 干预措施
Evening Rehabilitation Group
Participants will receive a standardized rehabilitation program including electrotherapy modalities (hot pack, TENS, and therapeutic ultrasound) and a structured exercise program focusing on motor control and core stabilization during daytime hours.
干预措施: Physiotherapy and Exercise Program (Behavioral)
Daytime Rehabilitation Group
Participants will receive a standardized rehabilitation program including electrotherapy modalities (hot pack, TENS, and therapeutic ultrasound) and a structured exercise program focusing on motor control and core stabilization during daytime hours.
干预措施: Physiotherapy and Exercise Program (Behavioral)
结局指标
主要结局
Daytime Sleepiness (Epworth Sleepiness Scale - ESS)
时间窗: Baseline and after 3 weeks (post-intervention)
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), ranging from 0 to 24, where higher scores indicate greater daytime sleepiness.
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
时间窗: Baseline and after 3 weeks (post-intervention)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with higher scores indicating poorer sleep quality.
次要结局
- Pain Intensity (Visual Analog Scale - VAS)(Baseline and 3 weeks (immediately after completion of the intervention))
- Functional Disability (Oswestry Disability Index - ODI)(Baseline and 3 weeks (immediately after completion of the intervention))
- Functional Exercise Capacity (6-Minute Walk Test)(Baseline and 3 weeks (immediately after completion of the intervention))
- Lumbar Flexion Mobility (Modified Schober Test)(Baseline and 3 weeks (immediately after completion of the intervention))
- Trunk Flexor Endurance (McGill Curl-Up Test)(Baseline and 3 weeks (immediately after completion of the intervention))
- Lateral Core Endurance (Side Plank Test)(Baseline and 3 weeks (immediately after completion of the intervention))
研究者
Engin Ramazanoglu
Assistant Professor
Mardin Artuklu University