Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evening Rehabilitation Group | Active Comparator | 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. |
|
| Daytime Rehabilitation Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 3 weeks (post-intervention) |
| 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. | Baseline and after 3 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (Visual Analog Scale - VAS) | Pain Intensity (Visual Analog Scale - VAS), ranging from 0 to 10, where higher scores indicate greater pain intensity. | Baseline and 3 weeks (immediately after completion of the intervention) |
| Functional Disability (Oswestry Disability Index - ODI) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| engin ramazanoÄŸlu, Assistant Professor | Contact | +905334889447 | enginramazanoglu@artuklu.edu.tr |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31909797 | Result | 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. | |
| 40538383 | Result | 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. |
Not provided
Not provided
Individual participant data will not be shared due to ethical and privacy considerations and institutional data protection policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
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.
Not provided
Not provided
This study is open-label. Due to the nature of the intervention (rehabilitation timing), blinding of participants and care providers is not feasible.
Not provided
|
|
Functional disability will be assessed using the Oswestry Disability Index (ODI), ranging from 0 to 100, where higher scores indicate greater disability. |
| Baseline and 3 weeks (immediately after completion of the intervention) |
| 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. | Baseline and 3 weeks (immediately after completion of the intervention) |
| 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. | Baseline and 3 weeks (immediately after completion of the intervention) |
| Trunk Flexor Endurance (McGill Curl-Up Test) | Trunk flexor muscle endurance will be assessed using the McGill Curl-Up Test, measured in seconds, where longer duration indicates better muscle endurance. | Baseline and 3 weeks (immediately after completion of the intervention) |
| Lateral Core Endurance (Side Plank Test) | Lateral trunk stability will be assessed using the Side Plank Test, measured in seconds, where longer duration indicates better lateral core endurance. | Baseline and 3 weeks (immediately after completion of the intervention) |
| 36414674 | Result | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |