HeadacheNCT05839496
Cervical Stabilization Training on Individuals With Headache
A study testing Cervical stabilization exercises in people with Headache, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Headache
- What is being tested?
- Cervical stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 2 Feb 2021
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- a clinical diagnosis of migraine, tension-type headache (TTH), and cervicogenic headache (CGH)
- age between 18 and 55 years
- being female
- frequency of headaches at least once a week or more in the last year
Who cannot join
- having a neurological and orthopedic disease such as Parkinson's, stroke, cognitive disorders, and temporomandibular joint dysfunction,
- having any contraindication for exercise,
- having any serious head and/or neck trauma,
- being with menopause,
- being included in a physiotherapy program for head and neck pain in the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cervical Stabilization Training on Individuals With Headache
Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. The effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.
Read the detailed description
Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. Most of the previous studies examined the effects of exercise programs such as Cranio-Cervical Flexion Exercises (CCFE), posture exercises, muscle strengthening, and stretching exercises of the neck and shoulder on headaches. These studies presented the beneficial effects of CCFE which mostly targeted strengthening the superficial neck and shoulder muscles. However, the effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.
- Conditions
- Headache
- Being tested
- Cervical stabilization exercises
- Keywords
- Headache, Neck pain, Exercise
- Medical subject headings
- Headache, Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical stabilization exercisesOther
Patients learned the activation of deep cervical flexor and extensor muscles. Then, during the activity of deep cervical muscles, superficial cervical muscles and upper extremity muscles were also strengthened. Thus, it was aimed to strengthen all neck muscles and upper extremity muscles in different positions synchronously and to increase their endurance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Stabilization Training Group | Experimental | The Cervical Stabilization Training Group applied cervical stabilization training three times a week for 8 weeks. Each session was completed in 45 minutes. Receives: Other: Cervical stabilization exercises |
| Control Group | No intervention | Control Group continued their medical treatment and they did not participate in any treatment for eight weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by the VAS
The average headache severity and neck pain severity in the last month was also assessed by using the Visual Analogue Scale (VAS). A Visual Analogue Scale (VAS) is one of the pain rating scales. A VAS consists of a line, often 10 cm long, with verbal anchors at either end (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Measured: Eight weeks
Forward head posture assessed by the craniovertebral angle
To evaluate the cervical posture, pictures were taken from the side to objectively measure the forward head posture. Patients were asked to stand straight and then relax while the camera was placed at shoulder level. After printing the pictures, the craniovertebral angle was measured to represent the degree of forward head posture. This angle was calculated by measuring the angle between a horizontal line drawn through the 7th cervical vertebra and a line connecting the tragus of the ear and C7 spinous process.
Measured: Eight weeks
Deep cervical flexor muscles strength assessed by the stabilizer pressure biofeedback
Cranio-Cervical Flexion Test : To begin the test, the patient is lying on a table in a supine position with their neck in a neutral position. A biofeedback stabilizer device is then placed under the patient's neck to rest against the occiput and inflated to a baseline pressure of 20 mmHg. During the test, the patient is asked to close their mouth with a slight gap between their jaws and place their tongue on the upper palate. They are then instructed to nod their head as if saying "yes." In the first stage of the test, the patient is asked to increase the pressure by 2 mmHg and maintain this position at 22 mmHg for 10 seconds. The patient is then asked to relax. In subsequent stages of the test, the pressure is reset to the initial pressure of 20 mmHg, and the patient is asked to perform the same head movement for 10 repetitions to create a pressure of 4, 6, 8, and 10 mmHg, respectively, and maintain the pressure for 10 seconds in each movement.
Measured: Eight weeks
Endurance of cervical muscles assessed by the chronometer
During the endurance test of cervical flexors, the patient is lying supıne position with the therapist's hand placed under their head. They are then asked to bring their chin closer to their chest, lifting their head about 2.5 cm and holding that position. The time they are able to maintain the position is recorded in seconds.
During the endurance test of cervical extensors, the patient is lying down with their heads bent downwards and their heads and chest hanging over the bed, with a 2-kg sandbag placed on the back of their necks. They are then asked to lift their heads to a neutral position and hold their position. The time they are able to maintain the position is recorded in seconds.
Measured: Eight weeks
Cervical joint range of motion assessed by the cervical range of motion instrument
The cervical joint range of motion was evaluated with a cervical joint range of motion measuring device. Active range of motion was measured in cervical flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion. Joint range of motion measurements were measured while the patient was sitting normally in an armless chair with a backrest.
Measured: Eight weeks
Secondary outcomes (5)
Disability level (headache) assessed by migraine disability rating scale
Migraine Disability Rating Scale: The Migraine Disability Assessment (MIDAS) questionnaire is a tool used to measure the impact of migraines on a person's daily life. It is a self-reported measure that assesses how much a person's headaches have affected their ability to perform daily activities, such as work, household chores, or social activities, over the past three months. The MIDAS questionnaire consists of five questions, with scores ranging from 0 to 270, and a higher score indicating a greater impact of migraine on daily activities.
The Migraine Disability Rating Scale (MIDAS) can be used to classify the severity of a person's migraines into one of four categories:
Grade I: Little or no disability, with a MIDAS score of 0-5. Grade II: Mild to moderate disability, with a MIDAS score of 6-10. Grade III: Moderate to severe disability, with a MIDAS score of 11-20. Grade IV: Severe disability, with a MIDAS score of more than 20.
Measured: Eight weeks
Disability level (neck pain) assessed by the neck disability index
The Neck Disability Index (NDI): is a questionnaire that assesses the level of disability experienced by a person with neck pain. It was developed to measure the impact of neck pain on a person's ability to perform daily activities and to provide a standardized way of assessing disability due to neck pain. The NDI consists of 10 questions, each addressing a different aspect of daily life. The questions cover areas such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. The patient rates their level of disability for each question on a scale of 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The scores for each question are then totaled. The maximum score is 50. The obtained score can be multiplied by 2 to produce a percentage score. Scoring intervals for interpretation, as follows:
0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete.
Measured: Eight weeks
Health-related quality of life assessed by the short form 36 quality of life scale
The Short Form 36 Quality of Life Scale (SF-36): is a self-reported questionnaire used to assess an individual's overall health-related quality of life. It includes 36 questions and covers eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status and a mean score of 50 has been articulated as a normative value for all scales.
Measured: Eight weeks
Sleep quality assessed by the Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI): is a self-reported questionnaire that assesses an individual's sleep quality and disturbances over a one-month time period. The questionnaire consists of 19 questions that are grouped into seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each category is scored on a scale of 0 to 3, with 3 indicating the greatest sleep disturbance. The seven category scores are then summed to produce a global PSQI score, which ranges from 0 to 21. A score of 5 or greater indicates poor sleep quality, while a score of 8 or greater is considered a severe sleep disturbance. The PSQI has been used in research studies and clinical settings to evaluate sleep quality and to identify individuals who may benefit from interventions to improve their sleep.
Measured: Eight weeks
Mood assessed by the Beck depression inventory
The Beck Depression Inventory (BDI): is a self-report questionnaire that measures the severity of depression in individuals. The BDI consists of 21 questions or items, each of which has four possible responses. The questions cover a range of symptoms commonly associated with depression, such as sadness, loss of interest in activities, feelings of worthlessness or guilt, changes in appetite or sleep, and thoughts of self-harm. The responses are scored on a scale from 0 to 3, with higher scores indicating more severe depression. The total score ranges from 0 to 63, with scores of 0-9 indicating minimal depression, scores of 10-18 indicating mild depression, scores of 19-29 indicating moderate depression, and scores of 30 or higher indicating severe depression.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 Jan 2019
- Primary completion2 Jan 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Ozkul, Gazi University
- Investigators
- Arzu Guclu-Gunduz, Prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839496
- Sponsor's protocol ID
- 730
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-de-Las-Penas C, Florencio LL, Plaza-Manzano G, Arias-Buria JL. Clinical Reasoning Behind Non-Pharmacological Interventions for the Management of Headaches: A Narrative Literature Review. Int J Environ Res Public Health. 2020 Jun 9;17(11):4126. doi: 10.3390/ijerph17114126.
PubMed 32527071Castien R, De Hertogh W. A Neuroscience Perspective of Physical Treatment of Headache and Neck Pain. Front Neurol. 2019 Mar 26;10:276. doi: 10.3389/fneur.2019.00276. eCollection 2019.
PubMed 30972008Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.
PubMed 24853166Edmondston SJ, Wallumrod ME, Macleid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010.
PubMed 18558277Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
PubMed 32051295Altmis Kacar H, Ozkul C, Baran A, Guclu-Gunduz A. Effects of cervical stabilization training in patients with headache: A single-blinded randomized controlled trial. Eur J Pain. 2024 Apr;28(4):633-648. doi: 10.1002/ejp.2208. Epub 2023 Nov 16.
PubMed 37970662
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Stabilization Training on Individuals With Headache
- ClinicalTrials.gov ID
- NCT05839496
- Acronym / sponsor ID
- 730
- Conditions
- Headache
- Keywords
- Headache, Neck pain, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 3 May 2023 (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.
Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. The effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.
Detailed description
Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. Most of the previous studies examined the effects of exercise programs such as Cranio-Cervical Flexion Exercises (CCFE), posture exercises, muscle strengthening, and stretching exercises of the neck and shoulder on headaches. These studies presented the beneficial effects of CCFE which mostly targeted strengthening the superficial neck and shoulder muscles. However, the effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Stabilization Training Group | Experimental | Other: Cervical stabilization exercisesThe Cervical Stabilization Training Group applied cervical stabilization training three times a week for 8 weeks. Each session was completed in 45 minutes. |
| Control Group | No intervention | –Control Group continued their medical treatment and they did not participate in any treatment for eight weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- a clinical diagnosis of migraine, tension-type headache (TTH), and cervicogenic headache (CGH)
- age between 18 and 55 years
- being female
- frequency of headaches at least once a week or more in the last year
Key exclusion criteria (5 listed)
- having a neurological and orthopedic disease such as Parkinson's, stroke, cognitive disorders, and temporomandibular joint dysfunction,
- having any contraindication for exercise,
- having any serious head and/or neck trauma,
- being with menopause,
- being included in a physiotherapy program for head and neck pain in the last 12 months.
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 |
|---|---|---|
| Cervical stabilization exercisesPatients learned the activation of deep cervical flexor and extensor muscles. Then, during the activity of deep cervical muscles, superficial cervical muscles and upper extremity muscles were also strengthened. Thus, it was aimed to strengthen all neck muscles and upper extremity muscles in different positions synchronously and to increase their endurance. | Other | Cervical Stabilization Training Group |
Primary outcome
Pain intensity assessed by the VAS
Time frame: Eight weeks
The average headache severity and neck pain severity in the last month was also assessed by using the Visual Analogue Scale (VAS). A Visual Analogue Scale (VAS) is one of the pain rating scales. A VAS consists of a line, often 10 cm long, with verbal anchors at either end (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Forward head posture assessed by the craniovertebral angle
Time frame: Eight weeks
To evaluate the cervical posture, pictures were taken from the side to objectively measure the forward head posture. Patients were asked to stand straight and then relax while the camera was placed at shoulder level. After printing the pictures, the craniovertebral angle was measured to represent the degree of forward head posture. This angle was calculated by measuring the angle between a horizontal line drawn through the 7th cervical vertebra and a line connecting the tragus of the ear and C7 spinous process.
Deep cervical flexor muscles strength assessed by the stabilizer pressure biofeedback
Time frame: Eight weeks
Cranio-Cervical Flexion Test : To begin the test, the patient is lying on a table in a supine position with their neck in a neutral position. A biofeedback stabilizer device is then placed under the patient's neck to rest against the occiput and inflated to a baseline pressure of 20 mmHg. During the test, the patient is asked to close their mouth with a slight gap between their jaws and place their tongue on the upper palate. They are then instructed to nod their head as if saying "yes." In the first stage of the test, the patient is asked to increase the pressure by 2 mmHg and maintain this position at 22 mmHg for 10 seconds. The patient is then asked to relax. In subsequent stages of the test, the pressure is reset to the initial pressure of 20 mmHg, and the patient is asked to perform the same head movement for 10 repetitions to create a pressure of 4, 6, 8, and 10 mmHg, respectively, and maintain the pressure for 10 seconds in each movement.
Endurance of cervical muscles assessed by the chronometer
Time frame: Eight weeks
During the endurance test of cervical flexors, the patient is lying supıne position with the therapist's hand placed under their head. They are then asked to bring their chin closer to their chest, lifting their head about 2.5 cm and holding that position. The time they are able to maintain the position is recorded in seconds. During the endurance test of cervical extensors, the patient is lying down with their heads bent downwards and their heads and chest hanging over the bed, with a 2-kg sandbag placed on the back of their necks. They are then asked to lift their heads to a neutral position and hold their position. The time they are able to maintain the position is recorded in seconds.
Cervical joint range of motion assessed by the cervical range of motion instrument
Time frame: Eight weeks
The cervical joint range of motion was evaluated with a cervical joint range of motion measuring device. Active range of motion was measured in cervical flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion. Joint range of motion measurements were measured while the patient was sitting normally in an armless chair with a backrest.
5 secondary outcomes
Disability level (headache) assessed by migraine disability rating scale
Time frame: Eight weeks
Disability level (neck pain) assessed by the neck disability index
Time frame: Eight weeks
Health-related quality of life assessed by the short form 36 quality of life scale
Time frame: Eight weeks
Sleep quality assessed by the Pittsburgh sleep quality index
Time frame: Eight weeks
Mood assessed by the Beck depression inventory
Time frame: Eight weeks
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 6 May 2023.
- Background: PubMed 32527071Fernandez-de-Las-Penas C, Florencio LL, Plaza-Manzano G, Arias-Buria JL. Clinical Reasoning Behind Non-Pharmacological Interventions for the Management of Headaches: A Narrative Literature Review. Int J Environ Res Public Health. 2020 Jun 9;17(11):4126. doi: 10.3390/ijerph17114126.
- Background: PubMed 30972008Castien R, De Hertogh W. A Neuroscience Perspective of Physical Treatment of Headache and Neck Pain. Front Neurol. 2019 Mar 26;10:276. doi: 10.3389/fneur.2019.00276. eCollection 2019.
- Background: PubMed 24853166Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.
- Background: PubMed 18558277Edmondston SJ, Wallumrod ME, Macleid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010.
- Background: PubMed 32051295Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
- Derived from this study: PubMed 37970662Altmis Kacar H, Ozkul C, Baran A, Guclu-Gunduz A. Effects of cervical stabilization training in patients with headache: A single-blinded randomized controlled trial. Eur J Pain. 2024 Apr;28(4):633-648. doi: 10.1002/ejp.2208. Epub 2023 Nov 16.
- 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.
Arzu Guclu-Gunduz, Prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical stabilization exercises in people with Headache, run by Gazi 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 4 inclusion and 5 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 6 May 2023. 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?
Pain intensity assessed by the VAS (time frame: Eight weeks). The study lists 5 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 NCT05839496, which also lists 6 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 6 May 2023.