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

NCT07522021 | Not Yet Recruiting

• 1 other identifier: 2026/2-10
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (6)

• Pain Intensity (Visual Analog Scale - VAS)

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

• Functional Disability (Oswestry Disability Index - ODI)

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

• Functional Exercise Capacity (6-Minute Walk Test)

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

• Lumbar Flexion Mobility (Modified Schober Test)

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

• Trunk Flexor Endurance (McGill Curl-Up Test)

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

Study Arms (2)

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.

Behavioral: Physiotherapy and Exercise Program

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.

Behavioral: Physiotherapy and Exercise Program

Interventions

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.

Also known as: Exercise Therapy, Physiotherapy

Daytime Rehabilitation Group; Evening Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mardin Artuklu University: lead

Related Publications (3)

• 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.

  PMID: 31909797 RESULT

• Correa LA,Moreira LF,Bittencourt JV,Nogueira LAC

  RESULT

• Ge L,Pereira MJ,Yap CW,Heng BH

  RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Interventions

Physical Therapy Modalities; Exercise Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

engin ramazanoğlu, Assistant Professor

CONTACT

+905334889447; enginramazanoglu@artuklu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label. Due to the nature of the intervention (rehabilitation timing), blinding of participants and care providers is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share