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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07522021
Acronym
REHAB-TIME
Enrollment
60
Registered
2026-04-13
Start date
2026-04-10
Completion date
2026-11-12
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management

Keywords

Lumbar Disc Herniation, Obstructive Sleep Apnea risk management, Sleep Quality, Daytime Sleepiness, Rehabilitation, Physiotherapy, Exercise Therapy, Randomized Controlled Trial

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPhysiotherapy 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 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.

Sponsors

Mardin Artuklu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This study is open-label. Due to the nature of the intervention (rehabilitation timing), blinding of participants and care providers is not feasible.

Intervention model description

Participants will be randomly assigned to one of two parallel groups: a daytime rehabilitation group or an evening rehabilitation group. Both groups will receive the same rehabilitation program, differing only in the timing of the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Daytime Sleepiness (Epworth Sleepiness Scale - ESS)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)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

MeasureTime frameDescription
Pain Intensity (Visual Analog Scale - VAS)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.
Functional Disability (Oswestry Disability Index - ODI)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.
Functional Exercise Capacity (6-Minute Walk Test)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.
Lumbar Flexion Mobility (Modified Schober Test)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.
Trunk Flexor Endurance (McGill Curl-Up Test)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.
Lateral Core Endurance (Side Plank Test)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.

Contacts

CONTACTengin ramazanoğlu, Assistant Professor
enginramazanoglu@artuklu.edu.tr+905334889447

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026