Facet Joint PainNCT03871192
Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome
A study testing FACET JOINT UNDER CT GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE and FACET JOINT UNDER FLUOROSCOPY GUIDANCE in people with Facet Joint Pain and Facet Syndrome of Lumbar Spine, run by Complejo Hospitalario Universitario de Granada at 2 sites in Spain.
Trial summary
In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Facet Joint Pain, Facet Syndrome of Lumbar Spine, Facet Joints; Degeneration
- What is being tested?
- FACET JOINT UNDER CT GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE and FACET JOINT UNDER FLUOROSCOPY GUIDANCE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Aug 2018to 15 Aug 2020
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.
- 3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months
Who cannot join
- Previous back surgery and other ablative treatments.
- Contraindication for the use of corticosteroid or local anesthetic.
- Uncontrolled acute or chronic medical illness.
- Pregnancy or lactation.
- Presence of inflammatory arthropathy or neuropathy.
- Wounds or skin lesions in the area.
Show all 10Show fewer
- Diabetes mellitus.
- Psychiatric disorders
- Refusal to participate in the study.
- Demonstration by imaging techniques of other causes that could justify the symptomatology.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Complejo Hospitalario Universitario Granada
Granada, SPA, 18014
JUANA MARIA DE HARO CASTELLANO, +34958 020124, juanam.haro.exts@juntadeandalucia.es
JUAN MORALES ARCAS, +34 958 023136, juan.morales.sspa@juntadeandalucia.es
- Recruiting
Hospital Neuro-Traumatologia
Granada, 1800314
JUANA MARIA DE HARO CASTELLANO, +34958 020124, juanam.haro.exts@juntadeandalucia.es
JUAN MORALES ARCA, +34 958 023136, juan.morales.sspa@juntadeandalucia.es
About this study
Official title: Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome
In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.
Read the detailed description
Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.
Facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.
The confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.
The investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.
Along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.
- Being tested
- FACET JOINT UNDER CT GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, FACET JOINT UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE
- Keywords
- FACET JOINTS, FACET INJECTIONS, NERVE BLOCK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACET JOINT UNDER CT GUIDANCEDiagnostic test
Also called facet joint, ct guidance
injection of triamcinolone in the facet joint under CT guidance
NERVE BLOCK UNDER CT GUIDANCEDiagnostic test
Also called posterior ramus, ct guidance
injection of triamcinolone around the dorsal ramus under CT guidance
FACET JOINT UNDER FLUOROSCOPY GUIDANCEDiagnostic test
Also called facet joint, fluoroscopy guidance
injection of triamcinolone in the facet joint under fluoroscopy guidance
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCEDiagnostic test
Also called posterior ramus, fluoroscopy guidance
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
FACET JOINT UNDER ULTRASOUND GUIDANCEDiagnostic test
Also called facet joint, ultrasound guidance
injection of triamcinolone in the facet joint under ultrasound guidance
NERVE BLOCK UNDER ULTRASOUND GUIDANCEDiagnostic test
Also called dorsal ramus, ultrasound guidance
injection of triamcinolone around the dorsal ramus under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| FACET JOINT UNDER CT GUIDANCE | Experimental | Injection of the facet joint under computed tomography guidance Receives: Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE; Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER CT GUIDANCE | Active comparator | Injection of the nerve under computed tomography guidance Receives: Diagnostic Test: FACET JOINT UNDER CT GUIDANCE; Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| FACET JOINT UNDER FLUOROSCOPY GUIDANCE | Experimental | Injection of the facet joint under fluoroscopy guidance Receives: Diagnostic Test: FACET JOINT UNDER CT GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE | Active comparator | Injection of the nerve under ultrasound guidance Receives: Diagnostic Test: FACET JOINT UNDER CT GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE; Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| FACET JOINT UNDER ULTRASOUND GUIDANCE | Experimental | Injection of the facet joint under ultrasound guidance Receives: Diagnostic Test: FACET JOINT UNDER CT GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE; Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER ULTRASOUND GUIDANCE | Active comparator | Injection of the nerve under computed ultrasound guidance Receives: Diagnostic Test: FACET JOINT UNDER CT GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE; Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE; Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS score)
score from no pain (0) to maximum pain (10)
Measured: 1 year
Secondary outcomes (1)
Oswestry scale
score from no disability(0) to maximum disability (10)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Aug 2018
- Primary completion15 Aug 2019 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the patients are randomly assigned to intraarticular injection or nerve block
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERNANDO RUIZ SANTIAGO, Complejo Hospitalario Universitario de Granada
- Investigators
- FERNANDO RUIZSANTIAGO, PhD, Principal investigator, HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871192
- Sponsor's protocol ID
- 0607-N-18
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome
- ClinicalTrials.gov ID
- NCT03871192
- Acronym / sponsor ID
- 0607-N-18
- Keywords
- FACET JOINTS, FACET INJECTIONS, NERVE BLOCK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Complejo Hospitalario Universitario de GranadaUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 12 Mar 2019 (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.
In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.
Detailed description
Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.
Facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.
The confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.
The investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.
Along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- the patients are randomly assigned to intraarticular injection or nerve block
| Arm | Type | Receives |
|---|---|---|
| FACET JOINT UNDER CT GUIDANCE | Experimental | Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE, Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCEInjection of the facet joint under computed tomography guidance |
| NERVE BLOCK UNDER CT GUIDANCE | Active comparator | Diagnostic Test: FACET JOINT UNDER CT GUIDANCE, Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCEInjection of the nerve under computed tomography guidance |
| FACET JOINT UNDER FLUOROSCOPY GUIDANCE | Experimental | Diagnostic Test: FACET JOINT UNDER CT GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCEInjection of the facet joint under fluoroscopy guidance |
| NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE | Active comparator | Diagnostic Test: FACET JOINT UNDER CT GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE, Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCEInjection of the nerve under ultrasound guidance |
| FACET JOINT UNDER ULTRASOUND GUIDANCE | Experimental | Diagnostic Test: FACET JOINT UNDER CT GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE, Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCEInjection of the facet joint under ultrasound guidance |
| NERVE BLOCK UNDER ULTRASOUND GUIDANCE | Active comparator | Diagnostic Test: FACET JOINT UNDER CT GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE, Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCEInjection of the nerve under computed ultrasound guidance |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.
- 3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months
Key exclusion criteria (10 listed)
- Previous back surgery and other ablative treatments.
- Contraindication for the use of corticosteroid or local anesthetic.
- Uncontrolled acute or chronic medical illness.
- Pregnancy or lactation.
- Presence of inflammatory arthropathy or neuropathy.
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 |
|---|---|---|
| FACET JOINT UNDER CT GUIDANCEAlso: facet joint, ct guidanceinjection of triamcinolone in the facet joint under CT guidance | Diagnostic test | FACET JOINT UNDER FLUOROSCOPY GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER CT GUIDANCEAlso: posterior ramus, ct guidanceinjection of triamcinolone around the dorsal ramus under CT guidance | Diagnostic test | FACET JOINT UNDER CT GUIDANCE, FACET JOINT UNDER FLUOROSCOPY GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| FACET JOINT UNDER FLUOROSCOPY GUIDANCEAlso: facet joint, fluoroscopy guidanceinjection of triamcinolone in the facet joint under fluoroscopy guidance | Diagnostic test | FACET JOINT UNDER CT GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER FLUOROSCOPY GUIDANCEAlso: posterior ramus, fluoroscopy guidanceinjection of triamcinolone around the dorsal ramus under fluoroscopy guidance | Diagnostic test | FACET JOINT UNDER CT GUIDANCE, FACET JOINT UNDER FLUOROSCOPY GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| FACET JOINT UNDER ULTRASOUND GUIDANCEAlso: facet joint, ultrasound guidanceinjection of triamcinolone in the facet joint under ultrasound guidance | Diagnostic test | FACET JOINT UNDER CT GUIDANCE, FACET JOINT UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE, NERVE BLOCK UNDER ULTRASOUND GUIDANCE |
| NERVE BLOCK UNDER ULTRASOUND GUIDANCEAlso: dorsal ramus, ultrasound guidanceinjection of triamcinolone around the dorsal ramus under ultrasound guidance | Diagnostic test | FACET JOINT UNDER CT GUIDANCE, FACET JOINT UNDER FLUOROSCOPY GUIDANCE, FACET JOINT UNDER ULTRASOUND GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE, NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE |
Primary outcome
Pain (VAS score)
Time frame: 1 year
score from no pain (0) to maximum pain (10)
1 secondary outcome
Oswestry scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: Yes. our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.
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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.
FERNANDO RUIZSANTIAGO, PhD principal investigator
HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACET JOINT UNDER CT GUIDANCE, NERVE BLOCK UNDER CT GUIDANCE and FACET JOINT UNDER FLUOROSCOPY GUIDANCE in people with Facet Joint Pain and Facet Syndrome of Lumbar Spine, run by Complejo Hospitalario Universitario de Granada at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALBERTO MARTINEZ MARTINEZ, MD (+34645558225, rralbert.martinez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS score) (time frame: 1 year). 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 15 Mar 2019.