Cervical Radicular PainNCT06069362
Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
A study testing Manual physiotherapy and neurodynamic exercises in people with Cervical Radicular Pain and Cervical Radiculopathy, run by University of Deusto at 1 site in Spain.
Trial summary
The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radicular Pain, Cervical Radiculopathy, Cervical Pain
- What is being tested?
- Manual physiotherapy and neurodynamic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2023to 20 Jul 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with unilateral cervicobrachial pain
Who cannot join
- Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin.
- Cervicobrachial pain of traumatic origin or as a result of whiplash.
- Previous surgical intervention of the cervical spine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Deusto
San Sebastián, Gipuzkoa, 20012
Xabat Casado, PhD cand, 943326600 ext. 5247, xabat.casado@deusto.es
Xabat Casado, Phd Cand
About this study
Official title: Prediction of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment.
Participants will be assessed for clinical and neurophysiological characteristics prior to treatment. Afterwards they will receive 6 sessions of manual physiotherapy treatment along with home nerve gliding exercises once a week. Baseline measurements will be taken again after treatment to know if there have been any changes.
Read the detailed description
During the first visit, socio-demographic data will be collected. Then, participants will be assessed using the quantitative sensory testing (QST) to evaluate the excitability of the nervous system. In addition, questionnaires and scales will be used to obtain information on the psychosocial factors involved, neuropathic pain characteristics and on the disability caused by their situation.
Finally, various clinical tests will be carried out to obtain information on neck movement and irritability at closure of the intervertebral foramen, mechanosensitivity of the upper limb with neurodynamic testing and alterations in sensitivity, strength and myotatic reflexes. Also they will be asked for permission to access to their imaging tests.
Once the pre-treatment data has been obtained, the manual physiotherapy and exercise treatment will begin, which aims to reduce the irritability of the nervous system.
Once the treatment is completed, the initial measurements will be repeated along with a global rating of change scale to classify patients as responders vs. non-responders.
- Being tested
- Manual physiotherapy and neurodynamic exercises
- Keywords
- Cervicobrachial pain, Nerve related neck arm pain
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual physiotherapy and neurodynamic exercisesOther
Also called Manual physiotherapy and exercise
- Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve. These techniques aim to open the nerve root foramen. They are gentle traction techniques and contralateral lateral glide mobilisation techniques. Interface techniques for scalenes will also be included.
- Home exercises for cervical mobility and neurodynamic sliders of the upper extremity: Patients will be taught progressive upper extremity neurodynamic sliders, starting with gentle movement and progressing to exercises involving more movement based on the patient's irritability.
| Study group | Role | What they receive |
|---|---|---|
| Manual physiotherapy and neurodynamic exercises | Experimental | The treatment applied forms part of the routine clinical practice and includes the following:
* Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve root.
* Home neurodynamic sliders of the upper limb and cervical mobility exercises. Receives: Other: Manual physiotherapy and neurodynamic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating of change scale
Is a self-administered questionnaire that aims to measure the degree of subjective improvement since the first intervention received. The questionnaire is scored with 7 positive items to assess the patient's subjective improvement progressively. It also presents 7 negative items to assess whether the patient has worsened. The 0 is defined as no improvement or worsening, the patient is the same.
Measured: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14
Secondary outcomes (26)
Numeric Pain Rating Scale (NPRS)
Neck and arm pain over the last 24 hours will be assessed with the NPRS. 0 is considered as no pain and 10 as the worst pain imaginable.
Measured: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Neck Disability Index
It is a unidimensional questionnaire consisting of 10 sections on different activities and measuring functionality.
Measured: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Central Sensitization Inventory (CSI)
CSI is a 25-item questionnaire to assess the presence of signs and symptoms consistent with central sensitisation.
Measured: Pre-intervention and post-intervention at week 6
Pain Detect Questionnaire (PD-Q)
Questionnaire consisting of temporal and spatial pain descriptors and sensory descriptors. The PD-Q classifies patients into 3 groups as follows:
- The result is negative = The neuropathic pain component is unlikely (Score 0 to 12).
- The result is unclear = The result is ambiguous, however, the neuropathic pain component may be present (Score 13 to 18).
- The result is positive = Neuropathic pain is likely to be present (Score 19 to 38).
The intensity of the most intense and average pain during the last 4 weeks is recorded on an NPRS as part of the PD-Q.
Measured: Pre-intervention and post-intervention at week 6
Patient Specific Functional Scale (PSFS)
PSFS is a scale that measures a patient's functional status by asking about activities that are difficult to perform based on their condition and scoring the level of limitation of each activity.
Measured: Pre-intervention and post-intervention at week 6
Tampa Scale of Kinesiophobia (TSK-11)
It is an 11-item questionnaire developed to identify fear of of movement.
Measured: Pre-intervention and post-intervention at week 6
Patient Catastrophizing Scale
It is a 13-item questionnaire developed to identify catastrophising thoughts or feelings in relation to painful experiences.
Measured: Pre-intervention and post-intervention at week 6
Scale for sleep quality
An increasing scale of 0-10 will be used to assess the quality of sleep. 0 is considered to be very poor sleep quality as a result of the pain, and 10 is considered to be no sleep disturbance.
Measured: Pre-intervention and post-intervention at week 6
Hospital anxiety and depression scale
Is one of the most widely used tests to measure anxiety and depression in a general population of patients.
Measured: Pre-intervention and post-intervention at week 6
Clinical examination
The clinical examination will include a detailed anamnesis considering items published by other studies.
Measured: Pre-intervention and post-intervention at week 6
Sensitivity to touch
The sensitivity to touch of the different dermatomes involved in the upper extremity will be evaluated by means of a piece of cotton and with a toothpick by means of the neuropen. The sensitivity of the healthy limb will be compared with that affected in upper extremity dermatomes. The patient should tell us if there are alterations in sensitivity and if he perceives the stimulus in a more noticeable, similar or lesser way. Results will be noted as hyperesthesia, normoestesia, or hypoesthesia.
Measured: Pre-intervention and post-intervention at week 6
Myotatic reflexes of the upper extremity
The reflex hammer will be used to evaluate the response of the roots of C5 and C6 by percussion in the biceps tendon and percussion in the triceps tendon for the evaluation of the roots of C6 and C7. The healthy and affected limb will be examined and compared for asymmetries indicating pathology
Measured: Pre-intervention and post-intervention at week 6
Myotomes examination
The loss of strength will be manually examined that would indicate a loss of function of different nerve roots.
Measured: Pre-intervention and post-intervention at week 6
Spurling test
It consists of performing a homolateral inclination that aims to reduce the intervertebral foramen along with a compression. The test is considered positive with reproduction of symptoms.
Measured: Pre-intervention and post-intervention at week 6
Distraction test
It consists of slightly pulling the cervical spine with the patient in supine position. The reduction of symptoms during the test is considered positive.
Measured: Pre-intervention and post-intervention at week 6
Extension + rotation test
With the patient in supine position, an extension and homolateral rotation is performed. The reproduction of the symptoms suggests facet involvement in the patient's clinical picture.
Measured: Pre-intervention and post-intervention at week 6
Range of motion in rotation
The patient will be asked to perform a bilateral active rotation. Limitation of mobility to the symptomatological ipsilateral side will be considered positive.
Measured: Pre-intervention and post-intervention at week 6
Examination of increased mechanosensitivity of nervous tissue
It will be evaluated using neurodynamic tests of the upper extremity (ULNT1, ULNT 2 and ULNT 3) and palpation of the median, radial and ulnar nerves. ULNTs are passive brachial plexus and nerve provocation tests to be evaluated performed supine, involving a sequence of movements that gradually add tension to the nerve trunk. The test will be considered positive with reproduction of arm symptoms at least partially and with the presence of structural differentiation. Structural differentiation involves modifying some of the movements of the sequence away from the area of onset of symptoms. It is a feature frequently used to involve nerve tissue in the symptoms reproduced.
Measured: Pre-intervention and post-intervention at week 6
Pain mapping
The participant will be asked to draw, on an electronic body map, the location and intensity of their symptoms.
Measured: Pre-intervention and post-intervention at week 6
Detection and thermal pain thresholds
Part of the QST protocol standardised by the German Research Network on Neuropathic Pain will be applied.This includes detection and thermal pain thresholds.
The thermal thresholds will be measured using the MSA Thermotest (Somedic) with 9 cm thermode. The reference temperature will be set at 32°C. The cutting temperatures will be 5ºC and 50ºC. All thresholds will be obtained with ramp stimuli (1ºC/sec) that will stop voluntarily when the subject presses a button. Firstly, the cold and heat detection thresholds will be evaluated, and finally the measurement of the cold and heat pain thresholds. The average threshold temperature of 3 valid consecutive measurements will be calculated for each parameter.
Measured: Pre-intervention and post-intervention at week 6
Vibration detection threshold
It will be measured with a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale). The threshold will be determined as a threshold of disappearance of perception with 3 repetitions of stimuli. Measurements will be taken over bony prominences unless the area of maximum pain does not exhibit a bony surface, in which case, measurements will be taken over adjacent soft tissue.
Measured: Pre-intervention and post-intervention at week 6
Pressure pain threshold
It will be determined with a pressure algometer with a contact surface of 1 cm2 and a ramp speed of 50kPa/s (Somedic). Subjects will be asked to press a button when the sensation changes from pressure to pressure pain. The average value of the measurements in triplicate shall be used for the analysis.
Measured: Pre-intervention and post-intervention at week 6
Temporal summation of pain
It will be measured by a repetitive pinprick stimulus at a controlled intensity using the set of pinprick stimulators (MRC systems). The perceived magnitude of a single puncture stimulus (256mN) will be compared to that of a series of 10 puncture stimuli of the same force repeated at a rate of 1/sec.
Measured: Pre-intervention and post-intervention at week 6
Conditioned pain modulation
The cold pressor test will be used to evaluate the efficacy of endogenous pain inhibitory mechanisms. Patients will immerse the healthy limb's hand in an insulated container filled with cold water. The pressure pain threshold (PPT) test will be applied as a test stimulus to determine the potential effect of conditioned pain modulation during the application of the cold stimulus.
Measured: Pre-intervention and post-intervention at week 6
Offset Analgesia
Using the thermode, we will identify the value for the heat pain threshold to obtain a value of 5/10 in the NPRS and then raise it by 1°C to obtain a new supra-threshold NPRS value. After a few seconds the temperature will be lowered back to the initial value and we will assess for changes in pain perception in the NPRS.
Measured: Pre-intervention and post-intervention at week 6
Magnetic resonance imaging and radiography
The patient will be asked for permission to access the tests performed as part of the medical diagnosis, in order to study whether the morphological changes produced by the aging of the patient (baseline situation) can be predictors of the response to treatment
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Apr 2023
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Jul 2025 (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 Cervical Radicular PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm clinical trial
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Matia Foundation, Osakidetza
- Responsible party
- Principal investigator, Xabat Casado, University of Deusto
- Investigators
- Xabat Casado, PhD cand, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069362
- Sponsor's protocol ID
- FST_DCB
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid AB, Hailey L, Tampin B. Entrapment Neuropathies: Challenging Common Beliefs With Novel Evidence. J Orthop Sports Phys Ther. 2018 Feb;48(2):58-62. doi: 10.2519/jospt.2018.0603.
PubMed 29385943Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.
PubMed 19762151Vardeh D, Mannion RJ, Woolf CJ. Toward a Mechanism-Based Approach to Pain Diagnosis. J Pain. 2016 Sep;17(9 Suppl):T50-69. doi: 10.1016/j.jpain.2016.03.001.
PubMed 27586831
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
- ClinicalTrials.gov ID
- NCT06069362
- Acronym / sponsor ID
- FST_DCB
- Keywords
- Cervicobrachial pain, Nerve related neck arm pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Matia Foundation, Osakidetza
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 5 Oct 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.
The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment.
Participants will be assessed for clinical and neurophysiological characteristics prior to treatment. Afterwards they will receive 6 sessions of manual physiotherapy treatment along with home nerve gliding exercises once a week. Baseline measurements will be taken again after treatment to know if there have been any changes.
Detailed description
During the first visit, socio-demographic data will be collected. Then, participants will be assessed using the quantitative sensory testing (QST) to evaluate the excitability of the nervous system. In addition, questionnaires and scales will be used to obtain information on the psychosocial factors involved, neuropathic pain characteristics and on the disability caused by their situation.
Finally, various clinical tests will be carried out to obtain information on neck movement and irritability at closure of the intervertebral foramen, mechanosensitivity of the upper limb with neurodynamic testing and alterations in sensitivity, strength and myotatic reflexes. Also they will be asked for permission to access to their imaging tests.
Once the pre-treatment data has been obtained, the manual physiotherapy and exercise treatment will begin, which aims to reduce the irritability of the nervous system.
Once the treatment is completed, the initial measurements will be repeated along with a global rating of change scale to classify patients as responders vs. non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Manual physiotherapy and neurodynamic exercises | Experimental | Other: Manual physiotherapy and neurodynamic exercisesThe treatment applied forms part of the routine clinical practice and includes the following: * Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve root. * Home neurodynamic sliders of the upper limb and cervical mobility exercises. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with unilateral cervicobrachial pain
Key exclusion criteria (3 listed)
- Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin.
- Cervicobrachial pain of traumatic origin or as a result of whiplash.
- Previous surgical intervention of the cervical spine.
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 |
|---|---|---|
| Manual physiotherapy and neurodynamic exercisesAlso: Manual physiotherapy and exercise* Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve. These techniques aim to open the nerve root foramen. They are gentle traction techniques and contralateral lateral glide mobilisation techniques. Interface techniques for scalenes will also be included. * Home exercises for cervical mobility and neurodynamic sliders of the upper extremity: Patients will be taught progressive upper extremity neurodynamic sliders, starting with gentle movement and progressing to exercises involving more movement based on the patient's irritability. | Other | Manual physiotherapy and neurodynamic exercises |
Primary outcome
Global rating of change scale
Time frame: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14
Is a self-administered questionnaire that aims to measure the degree of subjective improvement since the first intervention received. The questionnaire is scored with 7 positive items to assess the patient's subjective improvement progressively. It also presents 7 negative items to assess whether the patient has worsened. The 0 is defined as no improvement or worsening, the patient is the same.
26 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Neck Disability Index
Time frame: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Central Sensitization Inventory (CSI)
Time frame: Pre-intervention and post-intervention at week 6
Pain Detect Questionnaire (PD-Q)
Time frame: Pre-intervention and post-intervention at week 6
Patient Specific Functional Scale (PSFS)
Time frame: Pre-intervention and post-intervention at week 6
Tampa Scale of Kinesiophobia (TSK-11)
Time frame: Pre-intervention and post-intervention at week 6
Patient Catastrophizing Scale
Time frame: Pre-intervention and post-intervention at week 6
Scale for sleep quality
Time frame: Pre-intervention and post-intervention at week 6
Hospital anxiety and depression scale
Time frame: Pre-intervention and post-intervention at week 6
Clinical examination
Time frame: Pre-intervention and post-intervention at week 6
Sensitivity to touch
Time frame: Pre-intervention and post-intervention at week 6
Myotatic reflexes of the upper extremity
Time frame: Pre-intervention and post-intervention at week 6
Myotomes examination
Time frame: Pre-intervention and post-intervention at week 6
Spurling test
Time frame: Pre-intervention and post-intervention at week 6
Distraction test
Time frame: Pre-intervention and post-intervention at week 6
Extension + rotation test
Time frame: Pre-intervention and post-intervention at week 6
Range of motion in rotation
Time frame: Pre-intervention and post-intervention at week 6
Examination of increased mechanosensitivity of nervous tissue
Time frame: Pre-intervention and post-intervention at week 6
Pain mapping
Time frame: Pre-intervention and post-intervention at week 6
Detection and thermal pain thresholds
Time frame: Pre-intervention and post-intervention at week 6
Vibration detection threshold
Time frame: Pre-intervention and post-intervention at week 6
Pressure pain threshold
Time frame: Pre-intervention and post-intervention at week 6
Temporal summation of pain
Time frame: Pre-intervention and post-intervention at week 6
Conditioned pain modulation
Time frame: Pre-intervention and post-intervention at week 6
Offset Analgesia
Time frame: Pre-intervention and post-intervention at week 6
Magnetic resonance imaging and radiography
Time frame: Pre-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 26 Mar 2025.
- Background: PubMed 29385943Schmid AB, Hailey L, Tampin B. Entrapment Neuropathies: Challenging Common Beliefs With Novel Evidence. J Orthop Sports Phys Ther. 2018 Feb;48(2):58-62. doi: 10.2519/jospt.2018.0603.
- Background: PubMed 19762151Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.
- Background: PubMed 27586831Vardeh D, Mannion RJ, Woolf CJ. Toward a Mechanism-Based Approach to Pain Diagnosis. J Pain. 2016 Sep;17(9 Suppl):T50-69. doi: 10.1016/j.jpain.2016.03.001.
- 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.
Xabat Casado, PhD cand principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual physiotherapy and neurodynamic exercises in people with Cervical Radicular Pain and Cervical Radiculopathy, run by University of Deusto at 1 site in Spain.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 Spain. 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?
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 Xabat Casado, PhD Cand (943326600 ext. 5247, xabat.casado@deusto.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global rating of change scale (time frame: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14). 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 NCT06069362, 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 26 Mar 2025.