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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMardin Artuklu University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Evening Rehabilitation GroupActive comparator 1 intervention
Group B: Daytime Rehabilitation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Daytime Sleepiness (Epworth Sleepiness Scale - ESS)

Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), ranging from 0 to 24, where higher scores indicate greater daytime sleepiness.

Time frame
Baseline and after 3 weeks (post-intervention)
2

Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with higher scores indicating poorer sleep quality.

Time frame
Baseline and after 3 weeks (post-intervention)

Secondary outcomes

1

Pain Intensity (Visual Analog Scale - VAS)

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

Time frame
Baseline and 3 weeks (immediately after completion of the intervention)
2

Functional Disability (Oswestry Disability Index - ODI)

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

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

Functional Exercise Capacity (6-Minute Walk Test)

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

Time frame
Baseline and 3 weeks (immediately after completion of the intervention)
4

Lumbar Flexion Mobility (Modified Schober Test)

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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