Lumbar Disc HerniationREHAB-TIMENCT07522021
Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea
A study testing Physiotherapy and Exercise Program in people with Lumbar Disc Herniation and Obstructive Sleep Apnea Risk Management, run by Mardin Artuklu University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management
- What is being tested?
- Physiotherapy and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 12 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Being tested
- Physiotherapy and Exercise Program
- Keywords
- Lumbar Disc Herniation, Obstructive Sleep Apnea risk management, Sleep Quality, Daytime Sleepiness, Rehabilitation, Physiotherapy, Exercise Therapy, Randomized Controlled Trial
- Medical subject headings
- Intervertebral Disc Displacement, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and Exercise ProgramBehavioural
Also called Exercise Therapy, Physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physiotherapy and Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after 3 weeks (post-intervention)
Secondary outcomes (6)
Pain Intensity (Visual Analog Scale - VAS)
Pain Intensity (Visual Analog Scale - VAS), ranging from 0 to 10, where higher scores indicate greater pain intensity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 weeks (immediately after completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion26 Aug 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522021
- Sponsor's protocol ID
- 2026/2-10
- Acronym
- REHAB-TIME
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations and institutional data protection policies.
Publications
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.
PubMed 31909797Correa 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.
PubMed 40538383Ge 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.
PubMed 36414674
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07522021
- Acronym / sponsor ID
- REHAB-TIME / 2026/2-10
- Keywords
- Lumbar Disc Herniation, Obstructive Sleep Apnea risk management, Sleep Quality, Daytime Sleepiness, Rehabilitation, Physiotherapy, Exercise Therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evening Rehabilitation Group | Active comparator | Behavioral: Physiotherapy and Exercise ProgramParticipants 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 | Behavioral: Physiotherapy and Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy and Exercise ProgramAlso: Exercise Therapy, PhysiotherapyParticipants 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. | Behavioural | Daytime Rehabilitation Group, Evening Rehabilitation Group |
Primary outcome
Daytime Sleepiness (Epworth Sleepiness Scale - ESS)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Pain Intensity (Visual Analog Scale - VAS)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Functional Disability (Oswestry Disability Index - ODI)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Functional Exercise Capacity (6-Minute Walk Test)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Lumbar Flexion Mobility (Modified Schober Test)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Trunk Flexor Endurance (McGill Curl-Up Test)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Lateral Core Endurance (Side Plank Test)
Time frame: Baseline and 3 weeks (immediately after completion of the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 31909797Husak 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.
- Results publication: PubMed 40538383Correa 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.
- Results publication: PubMed 36414674Ge 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Exercise Program in people with Lumbar Disc Herniation and Obstructive Sleep Apnea Risk Management, run by Mardin Artuklu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact engin ramazanoğlu, Assistant Professor (+905334889447, enginramazanoglu@artuklu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Sleepiness (Epworth Sleepiness Scale - ESS) (time frame: Baseline and after 3 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522021, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.