Central SensitisationNCT05146960
Relation Between Temporal Summation and Fatigue
A study testing Temporal summation in people with Central Sensitisation and Elbow Pain, run by University Ghent at 1 site in Belgium.
Trial summary
Central sensitization (CS) is a common feature in chronic musculoskeletal pain conditions including rheumatoid arthritis, chronic whiplash syndrome, fibromyalgia, temporomandibular joint disorders, low back pain and lateral elbow pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Sensitisation, Elbow Pain, Fatigue
- What is being tested?
- Temporal summation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Nov 2021to 1 Jan 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be healthy
Who cannot join
- have suffered pain at an intensity of more than 2/10 for more than 8 days in the preceding year;
- having had a pain condition in the last 6 months for which treatment was sought;
- have undergone surgery in the neck or elbow region in the preceding year;
- suffer major depression or psychiatric illness (diagnosed by a psychiatrist and being in medical or psychiatric treatment);
- be diagnosed with life threatening, metabolic, cardiovascular, neurologic, systemic diseases;
- be pregnant or have given birth in the preceding year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Evoked Temporal Summation in the Lateral Elbow Region on Cervical Muscle Endurance and Fatigue Characteristics
Central sensitization (CS) is a common feature in chronic musculoskeletal pain conditions including rheumatoid arthritis, chronic whiplash syndrome, fibromyalgia, temporomandibular joint disorders, low back pain and lateral elbow pain. CS is defined as "an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity". Clinical signs are allodynia, hyperalgesia and widespread pain, originating from the enhanced activity of central nervous system to peripheral afferent input from unimodal and polymodal receptors.
CS not only induces abnormal pain processing, it may also lead to motor performance dysfunction in chronic pain population. CS induce cortical reorganization including changes in gray matter, cortical representation and cortical excitability both in motor and somatosensory cortex. This process ultimately generates sensorimotor conflict that described as a mismatch between motor intention and sensory feedback, and may directly effect on motor performance. The structural changes in basal ganglia and reduced GABAergic activity in the motor cortex contribute to the alteration of the motor performance. It has been known that CS and fatigue, another indicator of the motor performance, has a bidirectional effect and fatigue is predicted by CS, independently of the presence of pain. CS affect fatigue via causing disrupted reward process, increased effort and pain expactation.
The increased cervical spine hypersensitivity in patients with LEP even if there is no accompanied neck or upper limb pain may also indicate of the fatigue as pain does not always suggest an injury and biomechanical damage to a tissue does not always suggest that an individual will experience pain. If neck muscle fatigue is effected by central sensitization in patients with LEP, it can be important to develop therapeutic strategies to prevent neck muscle fatigue as there is a relationship between fatigue and increased risk of injury. Despite the fact that central sensitization effect on neck pain has been well documented in patients with LEP, its role on fatigue had not gain enough clinical and research attention. To know about central sensitization effect on motor performance can also be useful for determine subgroup of population who have central sensitization. However, it is unknown whether remote body endurance alteration occur in lateral elbow pain or not.
Read the detailed description
EMG assessment Electrode Placement Before electrode placement, the skin will be cleaned with alcohol to reduce skin impedance.
Sternocleidomastoid Muscle (SCM) Electrode Placement Electrodes will be placed to the the sternal head of the SCM while participants were sitting in a erect position. A line will be drawn from the sternal notch to the mastoid process and marked at 1/3 of the distance from the sternal notch. Electrodes initially will placed adjacent to the this point with 20 mm apart and over the muscle belly based on the muscle palpation during manually resisted neck flexion contractions. This location is anticipated to place between the innervation zone and the tendon. In supine, the head will be placed in a neutral anatomic position that craniocervical and cervical spine is in a mid position. It will be ensured visually by examiner that cervical spine is in the neutral position which means from the middle of the subject's forehead to the middle of the chin is horizontal and a line bisecting the neck longitudinally is parallel to the treatment plinth. Participants will asked to completely relax in this position. For normalization, isometric neck flexor contraction will be carried out in supine position via applying manual resistance on frontal region by gradually increasing force that reached maximum force level in 2 second and then contracted maximally for 5 second. This procedure will be repeated 3 times with a 30 second time interval.
Upper Trapezius (UT) Muscle Electrode Placement Electrodes will be attached 20% laterally to the midpoint between the dorsal processes of C4 and the posterior lateral third of the clavicle. For normalization, manual resistance will be given neck extensor while participant lying in prone position. Contraction will be lasted 5 second for 3 times with 30 interval.
After electrode placement, a 5 seconds rest recording will be performed for eliminating basal noise from recording. During the endurance test, participants will asked not to cough, laugh or talk and head position will be controlled by inclinometer adapted to EMG system. Participants will be given 3 minutes resting time between neck flexor/extensor endurance tests for the experimental group.
Neck Flexor Endurance Test An examiner will place her hand under the occiput of the participant, while the participant is lying in supine position with the knees bend and the arms resting on the abdomen. Cranicervical flexion will be taught to the participants. For this, participants will asked to place tongue on roof of the mouth, with lips together and teeth slightly apart while cervical spine is in neutral position. Participants will not be allowed to open mouth during the test. Participants will be requested to perform gentle head nodding as if saying "yes" via sliding head in caudal and cephalic directions on the bed and concentrate feeling of back of the head. After learning of the craniocervical flexion, the participant will be requested to head off from the examiners hand (approximately 2.5 cm from the plint) vhile maintaining the craniocervical flexion and then sustain this position as long as possible. The holding time will be recorded with a stopwatch. The test will be ended once the participant is unable to hold their head in a correct position that chances occur more than 5 degree for more than one second, can no longer maintain craniocervical flexion or head position due to fatigue.
Neck Extensor Endurance Test Participants will be asked to lie in a prone position maintaining thoracal extension with a strap at the level of T6, arms in their side and head is end of the plinth. The subject's head and neck will be positioned in a comfortable neutral position with the chin retracted. 2 kg weight will be placed around the participants head. Participants will be asked to sustain this position as long as possible after removing support from the head. The test will be ended when the participant can no longer sustain a correct position or when the head position changes more than 5 degrees. The holding time will be recorded with a stopwatch.
Experimental group:
Experimental pain induction: Temporal Summation Then participants will be asked to seat in a comfortable position placing their volar faces of the tested dominant arm in elbow flexion on a table during the experiment. The tested area will be marked with a pen to apply every stimulus in the same place.
Temporal summation will be evoked in a predetermined area:
- ECRL muscle origin: Distal humerus supracondylar ridge;
- ECRB muscle belly: identified with resisted radial wrist flexion
- Brachioradialis: 2 cm distal from in the middle of the line extend from lateral epicondyle to middle of the fossa cubiti via identifying resisted elbow flexion in 90° elbow flexion and wrist in neutral position Pressure pain thresholds (PPTs) will be identified two times with a 30 s interval for each predetermined area via applying circular probe in a perpendicular direction with an increasing pressure at a rate of approximately 1 kg/s. PPTs will be recorded when the sensation of the mechanical pressure stimulus changes into the first painful sensation. The average of two measurements will be used as a PPTs value. Temporal summation was induced two minutes after last PPTs was recorded. To evoke temporal summation at the lateral elbow, the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kg/s where it will be maintained for 1 s before being released with a 1 s interstimulus interval (ISI). This procedure will be repeated 10 times in each predetermined area. Pain intensity will be asked to participants at first, fifth and tenth pulse using a Visual Analog Scale range from "0 indicate no pain" to "10 most painful".
Placebo Group: After flexor and extensor endurance test, participants will be provided 20 minutes resting time. PPTs value will be evaluted once in each predetermined region with a 30 s interval.
Before PPTs assessment in predetermined area on lateral elbow, a familirisation session for the perceived PTTs by participants will be performed on palm of the non dominant arm for each group.
- Conditions
- Central Sensitisation, Elbow Pain, Fatigue
- Being tested
- Temporal summation, Placebo
- Keywords
- motor performance, pain, temporal summation
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal summationOther
Temporal summation will be evoked in each predetermined area
PlaceboOther
PPTs will be assessed once in each predetermined area
| Study group | Role | What they receive |
|---|---|---|
| Temporal summation | Experimental | Temporal summation will be evoked in ECRL muscle origin, ECRB muscle belly, Brachioradialis. Pressure pain thresholds (PPTs) will be identified two times with a 30 s interval for each predetermined area. The average of two measurements will be used as a PPTs value. Temporal summation was induced two minutes after last PPTs was recorded. To evoke temporal summation at the lateral elbow, the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kg/s where it will be maintained for 1 s before being released with a 1 s interstimulus interval (ISI). This procedure will be repeated 10 times in each predetermined area. Pain intensity will be asked to participants at first, fifth and tenth pulse using a Visual Analog Scale range from "0 indicate no pain" to "10 most painful Receives: Other: Temporal summation |
| Placebo | Placebo comparator | pressure pain threshold will be evaluated once in each predetermined region with a 30 second interval. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Sternocleidomastoid muscle normalized median frequency of the slope at 20 minutes
It shows fatigue characteristic of the muscle
Measured: Baseline and minutes 20
Secondary outcomes (3)
Change from baseline upper trapezius muscle normalized median frequency of the slope at 20 minutes
It shows fatigue characteristic of the muscle
Measured: Baseline and minutes 20
Changes from baseline mean amplitude of the sternocleidomastoid muscle at 20 minutes
It shows fatigue characteristic of the muscle
Measured: Baseline and minutes 20
Changes from baseline mean amplitude of the upper trapezius muscle at 20 minutes
It shows fatigue characteristic of the muscle
Measured: Baseline and minutes 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start9 Nov 2021
- Primary completion20 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146960
- Sponsor's protocol ID
- BC-10785
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canli K, Palmans T, Meeus M, De Meulemeester K. Excitation of the bottom-up pathways has no effect on remote muscle fatigue in healthy participants. Exp Brain Res. 2024 Nov 27;243(1):2. doi: 10.1007/s00221-024-06958-w.
PubMed 39601827
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Evoked Temporal Summation in the Lateral Elbow Region on Cervical Muscle Endurance and Fatigue Characteristics
- ClinicalTrials.gov ID
- NCT05146960
- Acronym / sponsor ID
- BC-10785
- Conditions
- Central Sensitisation, Elbow Pain, Fatigue
- Keywords
- motor performance, pain, temporal summation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 Dec 2021 (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.
Central sensitization (CS) is a common feature in chronic musculoskeletal pain conditions including rheumatoid arthritis, chronic whiplash syndrome, fibromyalgia, temporomandibular joint disorders, low back pain and lateral elbow pain. CS is defined as "an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity". Clinical signs are allodynia, hyperalgesia and widespread pain, originating from the enhanced activity of central nervous system to peripheral afferent input from unimodal and polymodal receptors.
CS not only induces abnormal pain processing, it may also lead to motor performance dysfunction in chronic pain population. CS induce cortical reorganization including changes in gray matter, cortical representation and cortical excitability both in motor and somatosensory cortex. This process ultimately generates sensorimotor conflict that described as a mismatch between motor intention and sensory feedback, and may directly effect on motor performance. The structural changes in basal ganglia and reduced GABAergic activity in the motor cortex contribute to the alteration of the motor performance. It has been known that CS and fatigue, another indicator of the motor performance, has a bidirectional effect and fatigue is predicted by CS, independently of the presence of pain. CS affect fatigue via causing disrupted reward process, increased effort and pain expactation.
The increased cervical spine hypersensitivity in patients with LEP even if there is no accompanied neck or upper limb pain may also indicate of the fatigue as pain does not always suggest an injury and biomechanical damage to a tissue does not always suggest that an individual will experience pain. If neck muscle fatigue is effected by central sensitization in patients with LEP, it can be important to develop therapeutic strategies to prevent neck muscle fatigue as there is a relationship between fatigue and increased risk of injury. Despite the fact that central sensitization effect on neck pain has been well documented in patients with LEP, its role on fatigue had not gain enough clinical and research attention. To know about central sensitization effect on motor performance can also be useful for determine subgroup of population who have central sensitization. However, it is unknown whether remote body endurance alteration occur in lateral elbow pain or not.
Detailed description
EMG assessment Electrode Placement Before electrode placement, the skin will be cleaned with alcohol to reduce skin impedance.
Sternocleidomastoid Muscle (SCM) Electrode Placement Electrodes will be placed to the the sternal head of the SCM while participants were sitting in a erect position. A line will be drawn from the sternal notch to the mastoid process and marked at 1/3 of the distance from the sternal notch. Electrodes initially will placed adjacent to the this point with 20 mm apart and over the muscle belly based on the muscle palpation during manually resisted neck flexion contractions. This location is anticipated to place between the innervation zone and the tendon. In supine, the head will be placed in a neutral anatomic position that craniocervical and cervical spine is in a mid position. It will be ensured visually by examiner that cervical spine is in the neutral position which means from the middle of the subject's forehead to the middle of the chin is horizontal and a line bisecting the neck longitudinally is parallel to the treatment plinth. Participants will asked to completely relax in this position. For normalization, isometric neck flexor contraction will be carried out in supine position via applying manual resistance on frontal region by gradually increasing force that reached maximum force level in 2 second and then contracted maximally for 5 second. This procedure will be repeated 3 times with a 30 second time interval.
Upper Trapezius (UT) Muscle Electrode Placement Electrodes will be attached 20% laterally to the midpoint between the dorsal processes of C4 and the posterior lateral third of the clavicle. For normalization, manual resistance will be given neck extensor while participant lying in prone position. Contraction will be lasted 5 second for 3 times with 30 interval.
After electrode placement, a 5 seconds rest recording will be performed for eliminating basal noise from recording. During the endurance test, participants will asked not to cough, laugh or talk and head position will be controlled by inclinometer adapted to EMG system. Participants will be given 3 minutes resting time between neck flexor/extensor endurance tests for the experimental group.
Neck Flexor Endurance Test An examiner will place her hand under the occiput of the participant, while the participant is lying in supine position with the knees bend and the arms resting on the abdomen. Cranicervical flexion will be taught to the participants. For this, participants will asked to place tongue on roof of the mouth, with lips together and teeth slightly apart while cervical spine is in neutral position. Participants will not be allowed to open mouth during the test. Participants will be requested to perform gentle head nodding as if saying "yes" via sliding head in caudal and cephalic directions on the bed and concentrate feeling of back of the head. After learning of the craniocervical flexion, the participant will be requested to head off from the examiners hand (approximately 2.5 cm from the plint) vhile maintaining the craniocervical flexion and then sustain this position as long as possible. The holding time will be recorded with a stopwatch. The test will be ended once the participant is unable to hold their head in a correct position that chances occur more than 5 degree for more than one second, can no longer maintain craniocervical flexion or head position due to fatigue.
Neck Extensor Endurance Test Participants will be asked to lie in a prone position maintaining thoracal extension with a strap at the level of T6, arms in their side and head is end of the plinth. The subject's head and neck will be positioned in a comfortable neutral position with the chin retracted. 2 kg weight will be placed around the participants head. Participants will be asked to sustain this position as long as possible after removing support from the head. The test will be ended when the participant can no longer sustain a correct position or when the head position changes more than 5 degrees. The holding time will be recorded with a stopwatch.
Experimental group:
Experimental pain induction: Temporal Summation Then participants will be asked to seat in a comfortable position placing their volar faces of the tested dominant arm in elbow flexion on a table during the experiment. The tested area will be marked with a pen to apply every stimulus in the same place.
Temporal summation will be evoked in a predetermined area:
- ECRL muscle origin: Distal humerus supracondylar ridge;
- ECRB muscle belly: identified with resisted radial wrist flexion
- Brachioradialis: 2 cm distal from in the middle of the line extend from lateral epicondyle to middle of the fossa cubiti via identifying resisted elbow flexion in 90° elbow flexion and wrist in neutral position Pressure pain thresholds (PPTs) will be identified two times with a 30 s interval for each predetermined area via applying circular probe in a perpendicular direction with an increasing pressure at a rate of approximately 1 kg/s. PPTs will be recorded when the sensation of the mechanical pressure stimulus changes into the first painful sensation. The average of two measurements will be used as a PPTs value. Temporal summation was induced two minutes after last PPTs was recorded. To evoke temporal summation at the lateral elbow, the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kg/s where it will be maintained for 1 s before being released with a 1 s interstimulus interval (ISI). This procedure will be repeated 10 times in each predetermined area. Pain intensity will be asked to participants at first, fifth and tenth pulse using a Visual Analog Scale range from "0 indicate no pain" to "10 most painful".
Placebo Group: After flexor and extensor endurance test, participants will be provided 20 minutes resting time. PPTs value will be evaluted once in each predetermined region with a 30 s interval.
Before PPTs assessment in predetermined area on lateral elbow, a familirisation session for the perceived PTTs by participants will be performed on palm of the non dominant arm for each group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal summation | Experimental | Other: Temporal summationTemporal summation will be evoked in ECRL muscle origin, ECRB muscle belly, Brachioradialis. Pressure pain thresholds (PPTs) will be identified two times with a 30 s interval for each predetermined area. The average of two measurements will be used as a PPTs value. Temporal summation was induced two minutes after last PPTs was recorded. To evoke temporal summation at the lateral elbow, the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kg/s where it will be maintained for 1 s before being released with a 1 s interstimulus interval (ISI). This procedure will be repeated 10 times in each predetermined area. Pain intensity will be asked to participants at first, fifth and tenth pulse using a Visual Analog Scale range from "0 indicate no pain" to "10 most painful |
| Placebo | Placebo comparator | Other: Placebopressure pain threshold will be evaluated once in each predetermined region with a 30 second interval. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be healthy
Key exclusion criteria (6 listed)
- have suffered pain at an intensity of more than 2/10 for more than 8 days in the preceding year;
- having had a pain condition in the last 6 months for which treatment was sought;
- have undergone surgery in the neck or elbow region in the preceding year;
- suffer major depression or psychiatric illness (diagnosed by a psychiatrist and being in medical or psychiatric treatment);
- be diagnosed with life threatening, metabolic, cardiovascular, neurologic, systemic diseases;
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 |
|---|---|---|
| Temporal summationTemporal summation will be evoked in each predetermined area | Other | Temporal summation |
| PlaceboPPTs will be assessed once in each predetermined area | Other | Placebo |
Primary outcome
Change from baseline Sternocleidomastoid muscle normalized median frequency of the slope at 20 minutes
Time frame: Baseline and minutes 20
It shows fatigue characteristic of the muscle
3 secondary outcomes
Change from baseline upper trapezius muscle normalized median frequency of the slope at 20 minutes
Time frame: Baseline and minutes 20
Changes from baseline mean amplitude of the sternocleidomastoid muscle at 20 minutes
Time frame: Baseline and minutes 20
Changes from baseline mean amplitude of the upper trapezius muscle at 20 minutes
Time frame: Baseline and minutes 20
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 11 Dec 2023.
- Derived from this study: PubMed 39601827Canli K, Palmans T, Meeus M, De Meulemeester K. Excitation of the bottom-up pathways has no effect on remote muscle fatigue in healthy participants. Exp Brain Res. 2024 Nov 27;243(1):2. doi: 10.1007/s00221-024-06958-w.
- 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 Temporal summation in people with Central Sensitisation and Elbow Pain, run by University Ghent at 1 site in Belgium.
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 6 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 11 Dec 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Change from baseline Sternocleidomastoid muscle normalized median frequency of the slope at 20 minutes (time frame: Baseline and minutes 20). 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 NCT05146960, which also lists 1 linked publication.
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 11 Dec 2023.