An interventional study of Physiotherapy and Exercise Program in Lumbar Disc Herniation and Obstructive Sleep Apnea Risk Management, sponsored by Mardin Artuklu University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Mardin Artuklu University · Not applicable, Interventional, and Treatment
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.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Mardin Artuklu University is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Physiotherapy and Exercise Program
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.
Behavioral: 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 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.
Also known as: Exercise Therapy, Physiotherapy
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)
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)
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)
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)
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)
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)
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.
Time frame: 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.
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to ethical and privacy considerations and institutional data protection policies.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement →
Mardin Artuklu University