Low Back Pain, ChronicNCT06895057
Telerehabilitation and Clinic-Applied Core Stabilization Exercises in Patients With Chronic Low Back Pain
A study testing Exercise in people with Low Back Pain, Chronic, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with chronic back pain between the ages of 25-55
- People with back pain for more than 3 months
- Ability to read and understand Turkish
- Volunteer to participate in the study
- Those with pain intensity above 3 on the Visual Analog Scale (VAS)
Who cannot join
- Not accepting to participate in the study,
- Having any pathology that causes back pain (e.g. infections, tumors or rheumatoid arthritis)
- Having liver, heart, lung, kidney failure or tumor
- Having a history of cerebrovascular disease
- Having a neurological disease or skeletal muscle degenerative disease
- Using assistive devices
Show all 10Show fewer
- Having cognitive disorders
- Being pregnant
- Having undergone orthopedic surgery in the last two years
- Those with scoliosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Islam Science and Technology University
Gaziantep, Şahinbey, 27000
About this study
Official title: Comparison of the Effects of Telerehabilitation and Clinic-Applied Core Stabilization Exercises on Pain, Quality of Life and Endurance in Patients With Chronic Low Back Pain
The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.
Read the detailed description
Low back pain is a common health problem worldwide, characterized by the persistence of its symptoms. It usually occurs as a musculoskeletal injury that can occur at work, during exercise, after a traumatic event, or from a condition of unknown cause. According to the National Institutes of Health, 80% of adults experience low back pain in their lifetime. Data from the 2015 National Health Interview Survey showed that the population with low back pain is over 140 million annually. Nonspecific low back pain is a type of pain where the cause cannot be specifically determined, such as tumors, spinal fractures, or infections. According to its duration, low back pain is classified as: acute pain (lasting less than 6 weeks); subacute pain (lasting between 6 weeks and 3 months); or chronic pain (lasting longer than 3 months).
There are various methods for the treatment of chronic low back pain. The aim of the treatment methods is to reduce pain, increase functionality and prevent deterioration in daily life activities. There is strong evidence in treatment-oriented studies that exercise training reduces pain and improves quality of life. The core region is responsible for the transfer of power between the upper and lower extremities of the body. All movements start from the core region and are transferred to the extremities. It is also the most important muscle group that provides body stabilization. The stability of the spine is negatively affected in people with low back pain. Generally, individuals with pain problems have poorly coordinated muscles around the spine and weakness in the core region. Core stabilization exercises aim to improve the strength and control of the muscles that are central to maintaining spinal stability. Telerehabilitation is an online or offline tool that allows personalized treatment of patients. It also allows patients to access information about their treatment and condition at any time. This reduces costs and geographical barriers. The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.
- Conditions
- Low Back Pain, Chronic
- Being tested
- Exercise
- Keywords
- Chronic low back pain, exercise, telerehabilitation, core stabilization
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Individuals who voluntarily accept to participate in the study will be divided into two groups as telerehabilitation and clinical practice groups by randomization. Exercises will be applied face to face to the clinical practice group and online to the telerehabilitation group via tablet. Individuals who will participate in the study will be applied twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face for both groups before and after the application. Treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be evaluated twice before and after the training by the same therapist in the clinic, face to face.
| Study group | Role | What they receive |
|---|---|---|
| telerehabilitation group | Experimental | The exercise program will be applied online via tablet.Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training.
The core stabilization exercise program to be applied is planned as follows.
* Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening)
* Finding neutral spine position (Pelvic Tilt)
* Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold)
* Table (abdominal exercise)
* Crawling position stretching exercises
* Plank exercises (Advanced plank exercises such as fixed hold, side plank, single leg pull-up Receives: Other: Exercise |
| clinical practice group | Experimental | The exercises will be applied face to face to the clinical practice group. Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training.
The core stabilization exercise program to be applied is planned as follows.
* Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening)
* Finding neutral spine position (Pelvic Tilt
* Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold)
* Table (abdominal exercise)
* Crawling position stretching exercises
* Plank exercises (Advanced plank exercises such as fixed hold, side plank Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used to digitize some data that cannot be measured numerically. VAS, developed by Max Freyd, is the most commonly used measurement method in the assessment of pain. The two extreme definitions of the parameter to be evaluated are written on the scale at both ends of a 100-millimeter line, and the patient is asked to indicate by marking the appropriate place on this line for his/her own situation. The starting point of the scale represents no pain, and the ending point represents the most severe pain.
Measured: At Baseline and 8 weeks after the baseline
Quality of Life Scale Short Form (SF-36)
This scale is one of the most common measures used to measure quality of life. It is a questionnaire that examines 8 parameters of health such as physical function, social function, mental health, vitality (energy), pain, role limitations (due to physical and emotional problems), and general perception of health with 36 items. The scale is a self-assessment scale. It can be completed in a short time. Instead of obtaining a single score at the end of the scale, each parameter has its own scoring. A score of 0 indicates poor health status, while 100 indicates good health status. Questions 3-12 are used for physical function, 13-16 for physical role difficulty, 17-19 for emotional role difficulty, 23,27,29,31 for energy, 24,25,26,28,30 for mental health, 20 and 32 for social functioning, 21-22 for pain, and 1 and 33-36 for general perception of health. Each item is scored mathematically according to the answer given within itself. For example, for emotional role difficulty, the transform
Measured: At Baseline and 8 weeks after the baseline
Mcgill Body Endurance Tests
Trunk flexion test: Individuals will be positioned with the soles of their feet on the floor, with knees and hips at 90° flexion, trunk at 60° flexion, and hands crossed on both shoulders. All individuals will be asked to maintain this position and a chronometer will be used to measure at the same time. When the position is disrupted, the test will be terminated and the elapsed time will be recorded in seconds. Trunk extension test: Individuals will be assessed in the prone position. Individuals will be asked to hang from the bed starting from the spina iliaca anterior superior and arms will be crossed on both shoulders. The lower extremity will be fixed by the researcher and individuals will be asked to move their trunks backwards. Trunk lateral bridge test: Individuals will be evaluated on both the right and left sides. For the right side, individuals will be positioned on the forearm with the arm perpendicular to the body, with the elbow flexed at 90°, with the body facing forward.
Measured: At Baseline and 8 weeks after the baseline
Oswestry Scale
The purpose of this index is to measure the functionality levels of individuals with low back pain. It evaluates the changes in parameters such as patients' lifting, pain intensity, personal care, sitting, walking, standing, traveling, social life, and sleeping when they are in pain. There are 6 propositions under each parameter. Patients choose the most appropriate proposition for them. In this way, a total score is obtained by obtaining a score between 0-5 from each question. A maximum of 50 points can be obtained as a result of the test. The score received by the patient is divided by the maximum score that can be obtained, which is 50, and the result obtained is multiplied by 100 to obtain the patient's score from the index.
Measured: At Baseline and 8 weeks after the baseline
Modified Schober Test
It will be used to evaluate the flexibility of the individuals to be included in the study. Both posterior spina iliaca will be marked. 10 cm above and 5 cm below the marked area is determined, the individual is asked to bend forward, the difference between the initial value will be recorded in cm. This measurement will be made to the patient twice, at the beginning of the treatment and at the end of the treatment. A difference of 0-5 cm in the test indicates that flexion flexibility has decreased, while a difference of over 10 cm indicates that flexibility has increased. Values between 5-10 cm are considered normal.
Measured: At Baseline and 8 weeks after the baseline
Patient Global Indicator of Change (PGIC)
It will be used as a scale of recovery and satisfaction in the 4th and 8th weeks of treatment. It is a 7-point scale that reflects the patient's evaluation of the effectiveness of the treatment. 1=No change, 2=Almost the same, 3=Slightly better, 4=Slightly better, 5=Moderately better, 6=Better, 7=Much better
Measured: 4 and 8 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start20 Mar 2025
- Primary completion15 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, ChronicStudies 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye Beyza Kolukısa, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895057
- Sponsor's protocol ID
- GIBTU-FTR--ZBK-1
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Telerehabilitation and Clinic-Applied Core Stabilization Exercises on Pain, Quality of Life and Endurance in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06895057
- Acronym / sponsor ID
- GIBTU-FTR--ZBK-1
- Conditions
- Low Back Pain, Chronic
- Keywords
- Chronic low back pain, exercise, telerehabilitation, core stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 26 Mar 2025 (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.
The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.
Detailed description
Low back pain is a common health problem worldwide, characterized by the persistence of its symptoms. It usually occurs as a musculoskeletal injury that can occur at work, during exercise, after a traumatic event, or from a condition of unknown cause. According to the National Institutes of Health, 80% of adults experience low back pain in their lifetime. Data from the 2015 National Health Interview Survey showed that the population with low back pain is over 140 million annually. Nonspecific low back pain is a type of pain where the cause cannot be specifically determined, such as tumors, spinal fractures, or infections. According to its duration, low back pain is classified as: acute pain (lasting less than 6 weeks); subacute pain (lasting between 6 weeks and 3 months); or chronic pain (lasting longer than 3 months).
There are various methods for the treatment of chronic low back pain. The aim of the treatment methods is to reduce pain, increase functionality and prevent deterioration in daily life activities. There is strong evidence in treatment-oriented studies that exercise training reduces pain and improves quality of life. The core region is responsible for the transfer of power between the upper and lower extremities of the body. All movements start from the core region and are transferred to the extremities. It is also the most important muscle group that provides body stabilization. The stability of the spine is negatively affected in people with low back pain. Generally, individuals with pain problems have poorly coordinated muscles around the spine and weakness in the core region. Core stabilization exercises aim to improve the strength and control of the muscles that are central to maintaining spinal stability. Telerehabilitation is an online or offline tool that allows personalized treatment of patients. It also allows patients to access information about their treatment and condition at any time. This reduces costs and geographical barriers. The aim of the study is to compare the effects of core stabilization exercises on pain, quality of life and endurance in individuals with chronic low back pain with telerehabilitation and in-clinic application. In this way, the effect of low-cost, easy-to-access and longer-term telerehabilitation in the treatment of chronic low back pain will be examined comparatively with face-to-face application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telerehabilitation group | Experimental | Other: ExerciseThe exercise program will be applied online via tablet.Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training. The core stabilization exercise program to be applied is planned as follows. * Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening) * Finding neutral spine position (Pelvic Tilt) * Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold) * Table (abdominal exercise) * Crawling position stretching exercises * Plank exercises (Advanced plank exercises such as fixed hold, side plank, single leg pull-up |
| clinical practice group | Experimental | Other: ExerciseThe exercises will be applied face to face to the clinical practice group. Individuals who will participate in the study will be put into practice twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face before and after the application for both groups. The treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be made face to face by the same therapist in the clinic, twice before and after the training. The core stabilization exercise program to be applied is planned as follows. * Warm-up exercises (10 minutes) (Straight leg raise, circle drawing, side opening) * Finding neutral spine position (Pelvic Tilt * Bridge exercise, (one leg pull-up in bridge, bridge rise, fixed hold) * Table (abdominal exercise) * Crawling position stretching exercises * Plank exercises (Advanced plank exercises such as fixed hold, side plank |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- People with chronic back pain between the ages of 25-55
- People with back pain for more than 3 months
- Ability to read and understand Turkish
- Volunteer to participate in the study
- Those with pain intensity above 3 on the Visual Analog Scale (VAS)
Key exclusion criteria (10 listed)
- Not accepting to participate in the study,
- Having any pathology that causes back pain (e.g. infections, tumors or rheumatoid arthritis)
- Having liver, heart, lung, kidney failure or tumor
- Having a history of cerebrovascular disease
- Having a neurological disease or skeletal muscle degenerative disease
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 |
|---|---|---|
| ExerciseIndividuals who voluntarily accept to participate in the study will be divided into two groups as telerehabilitation and clinical practice groups by randomization. Exercises will be applied face to face to the clinical practice group and online to the telerehabilitation group via tablet. Individuals who will participate in the study will be applied twice a week for 8 weeks, each session lasting 50 minutes. Pain, quality of life, endurance, functionality, and flexibility assessments will be taken face to face for both groups before and after the application. Treatment satisfaction scale (PGIC) will be taken from both groups in the 4th and 8th weeks. All assessments will be evaluated twice before and after the training by the same therapist in the clinic, face to face. | Other | clinical practice group, telerehabilitation group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: At Baseline and 8 weeks after the baseline
The Visual Analog Scale (VAS) will be used to digitize some data that cannot be measured numerically. VAS, developed by Max Freyd, is the most commonly used measurement method in the assessment of pain. The two extreme definitions of the parameter to be evaluated are written on the scale at both ends of a 100-millimeter line, and the patient is asked to indicate by marking the appropriate place on this line for his/her own situation. The starting point of the scale represents no pain, and the ending point represents the most severe pain.
Quality of Life Scale Short Form (SF-36)
Time frame: At Baseline and 8 weeks after the baseline
This scale is one of the most common measures used to measure quality of life. It is a questionnaire that examines 8 parameters of health such as physical function, social function, mental health, vitality (energy), pain, role limitations (due to physical and emotional problems), and general perception of health with 36 items. The scale is a self-assessment scale. It can be completed in a short time. Instead of obtaining a single score at the end of the scale, each parameter has its own scoring. A score of 0 indicates poor health status, while 100 indicates good health status. Questions 3-12 are used for physical function, 13-16 for physical role difficulty, 17-19 for emotional role difficulty, 23,27,29,31 for energy, 24,25,26,28,30 for mental health, 20 and 32 for social functioning, 21-22 for pain, and 1 and 33-36 for general perception of health. Each item is scored mathematically according to the answer given within itself. For example, for emotional role difficulty, the transform
Mcgill Body Endurance Tests
Time frame: At Baseline and 8 weeks after the baseline
Trunk flexion test: Individuals will be positioned with the soles of their feet on the floor, with knees and hips at 90° flexion, trunk at 60° flexion, and hands crossed on both shoulders. All individuals will be asked to maintain this position and a chronometer will be used to measure at the same time. When the position is disrupted, the test will be terminated and the elapsed time will be recorded in seconds. Trunk extension test: Individuals will be assessed in the prone position. Individuals will be asked to hang from the bed starting from the spina iliaca anterior superior and arms will be crossed on both shoulders. The lower extremity will be fixed by the researcher and individuals will be asked to move their trunks backwards. Trunk lateral bridge test: Individuals will be evaluated on both the right and left sides. For the right side, individuals will be positioned on the forearm with the arm perpendicular to the body, with the elbow flexed at 90°, with the body facing forward.
Oswestry Scale
Time frame: At Baseline and 8 weeks after the baseline
The purpose of this index is to measure the functionality levels of individuals with low back pain. It evaluates the changes in parameters such as patients' lifting, pain intensity, personal care, sitting, walking, standing, traveling, social life, and sleeping when they are in pain. There are 6 propositions under each parameter. Patients choose the most appropriate proposition for them. In this way, a total score is obtained by obtaining a score between 0-5 from each question. A maximum of 50 points can be obtained as a result of the test. The score received by the patient is divided by the maximum score that can be obtained, which is 50, and the result obtained is multiplied by 100 to obtain the patient's score from the index.
Modified Schober Test
Time frame: At Baseline and 8 weeks after the baseline
It will be used to evaluate the flexibility of the individuals to be included in the study. Both posterior spina iliaca will be marked. 10 cm above and 5 cm below the marked area is determined, the individual is asked to bend forward, the difference between the initial value will be recorded in cm. This measurement will be made to the patient twice, at the beginning of the treatment and at the end of the treatment. A difference of 0-5 cm in the test indicates that flexion flexibility has decreased, while a difference of over 10 cm indicates that flexibility has increased. Values between 5-10 cm are considered normal.
Patient Global Indicator of Change (PGIC)
Time frame: 4 and 8 weeks after the baseline
It will be used as a scale of recovery and satisfaction in the 4th and 8th weeks of treatment. It is a 7-point scale that reflects the patient's evaluation of the effectiveness of the treatment. 1=No change, 2=Almost the same, 3=Slightly better, 4=Slightly better, 5=Moderately better, 6=Better, 7=Much better
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Low Back Pain, Chronic, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: At Baseline and 8 weeks after the baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.