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NCT Number: NCT07522021

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Disorders of Excessive Somnolence Dyssomnias Hernia Intervertebral Disc Displacement Mental Disorders Musculoskeletal Diseases Nervous System Diseases Obstructive Sleep Apnea Risk Management Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Physiotherapy and Exercise Program

Behavioral

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 abdominis and multifidus muscles. Exercises will be progressively advanced from basic activation in supine position to functional stabilization tasks including bridging and quadruped exercises. Each session will last approximately 20 minutes and will be supervised by a physiotherapist.

Electrotherapy will be applied 5 days per week, while the exercise program will be performed 3 days per week for a total of 15 sessions. The only difference between groups is the timing of the intervention.

Other names: Exercise Therapy, Physiotherapy

Primary outcomes

  1. Daytime Sleepiness (Epworth Sleepiness Scale - ESS)

    Time frame: 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.

  2. Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

    Time frame: 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.

Secondary outcomes

  1. Pain Intensity (Visual Analog Scale - VAS)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Pain Intensity (Visual Analog Scale - VAS), ranging from 0 to 10, where higher scores indicate greater pain intensity.

  2. Functional Disability (Oswestry Disability Index - ODI)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Functional disability will be assessed using the Oswestry Disability Index (ODI), ranging from 0 to 100, where higher scores indicate greater disability.

  3. Functional Exercise Capacity (6-Minute Walk Test)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), measured in meters, where greater distance indicates better functional capacity.

  4. Lumbar Flexion Mobility (Modified Schober Test)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Lumbar mobility will be assessed using the Modified Schober Test, measured in centimeters, where greater values indicate better lumbar flexion mobility.

  5. Trunk Flexor Endurance (McGill Curl-Up Test)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Trunk flexor muscle endurance will be assessed using the McGill Curl-Up Test, measured in seconds, where longer duration indicates better muscle endurance.

  6. Lateral Core Endurance (Side Plank Test)

    Time frame: Baseline and 3 weeks (immediately after completion of the intervention)

    Lateral trunk stability will be assessed using the Side Plank Test, measured in seconds, where longer duration indicates better lateral core endurance.

Study contacts

Contact information is provided by the study sponsor or research team.

engin ramazanoğlu, Assistant Professor

CONTACT

[email protected]

+905334889447

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study title

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

Acronym: REHAB-TIME

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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