Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Physiotherapy and Exercise Program
  Participants will receive a standardized rehabilitation program consisting of electrotherapy modalities and therapeutic exercises. Electrotherapy includes hot pack application for 20 minutes, conventional TENS (60-100 Hz, 60 µs) applied at a comfortable sensory level for 20 minutes, and therapeutic ultrasound (1 MHz, 1.5 W/cm², continuous mode) for 5 minutes applied to the lumbar paravertebral region. The exercise program focuses on motor control and core stabilization targeting the transversus

Первичные конечные точки

• Daytime Sleepiness (Epworth Sleepiness Scale - ESS) [Срок оценки: Baseline and after 3 weeks (post-intervention)]
• Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) [Срок оценки: Baseline and after 3 weeks (post-intervention)]

Вторичные конечные точки (6)

• Pain Intensity (Visual Analog Scale - VAS) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]
• Functional Disability (Oswestry Disability Index - ODI) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]
• Functional Exercise Capacity (6-Minute Walk Test) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]
• Lumbar Flexion Mobility (Modified Schober Test) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]
• Trunk Flexor Endurance (McGill Curl-Up Test) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]
• Lateral Core Endurance (Side Plank Test) [Срок оценки: Baseline and 3 weeks (immediately after completion of the intervention)]

Критерии участия

Критерии включения

• 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 Exclusion Criteria:
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Husak AJ, Bair MJ. Chronic Pain and Sleep Disturbances: A Pragmatic Review of Their Relationships, Comorbidities, and Treatments. Pain Med. 2020 Jun 1;21(6):1142-1152. doi: 10.1093/pm/pnz343. PMID 31909797
• Correa LA, Moreira LF, Bittencourt JV, Nogueira LAC. Chronic back pain patients with poor sleep quality had higher pain intensity, functional limitation, and psychosocial factors than their counterparts. Sleep Biol Rhythms. 2025 Feb 6;23(3):275-282. doi: 10.1007/s41105-025-00574-z. eCollection 2025 Jul. PMID 40538383
• Ge L, Pereira MJ, Yap CW, Heng BH. Chronic low back pain and its impact on physical function, mental health, and health-related quality of life: a cross-sectional study in Singapore. Sci Rep. 2022 Nov 21;12(1):20040. doi: 10.1038/s41598-022-24703-7. PMID 36414674

Идентификаторы

NCT: NCT07522021 · 2026/2-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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