Carpal Tunnel SyndromePhase 4NCT05496764
Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome
A Phase 4 study testing Dexamethasone and Glucose Injection in people with Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Dexamethasone and Glucose Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to Jan 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female or male patient > 18y
- mild to moderate cases of carpal tunnel syndrome according to Bland's Neurophysiological Grading Scale for Patients with CTS
- clear consent to participate in the study
Who cannot join
- age younger than 18y.
- severe cases of CTS.
- systemic diseases cause CTS .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71511
Eman MH Khedr, Professor, 0020100 585 0632, Emankhedr99@yahoo.com
About this study
Official title: The Therapeutic Effect and Quality of Life After Local Injection of Steroid VS. Glucose 5% for Carpal Tunnel Syndrome : Double-blinded Clinical Trial
To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most prevalent type of peripheral nerve entrapment involving compression of the median nerve in the carpal tunnel. 1 This condition is more common in females than in males. CTS may be unilateral or bilateral. It is a significant cause of morbidity and poor quality of life in those patients. There is deterioration in functional outcomes and maybe psychologically as well. The severity of CTS varied from mild to moderate to severe. Its signs and symptoms include numbness along with the median nerve distribution of the hand, pain, atrophy of muscles, handgrip weakness, etc. Mild or moderate cases are usually seeking conservative treatment like electrotherapeutic modalities, manual therapy interventions, oral supplements and medications, and wrist immobilizations such as splints. Severe cases are likely to go toward surgery. But most patients with CTS are reluctant to take the surgical choice, mainly because of financial issues and secondary complications. Therefore, the evaluation of the effectiveness of the non-surgical (conservative) therapies should be a major concern, as they are cost-effective and lacks secondary complications. Much research has been conducted to see the efficacy of various conservative therapies.
-study method: We are going to carry out a double-blinded randomized, case-controlled study on 52 patients who are randomly chosen and categorized them into 2 groups, 26 patients each. we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group 1) and to inject 10 ml glucose 5% into the carpal tunnel for the other group (group 2).. All injections will be under sonographic guidance. Neurophysiology, U/S, pain scales, and quality of life scales studies will be performed for these two groups before treatment and after 12 weeks of injection. The patients will be followed up for 3 months.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Dexamethasone, Glucose Injection
- Keywords
- local injection, pain relief, steroid, glucose 5%
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in group A
Glucose InjectionDrug
Also called glucose 5%
inject10 ml glucose 5% into the carpal tunnel in group B
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 26 patients we planned to inject them local steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group A) Receives: Drug: Dexamethasone; Drug: Glucose Injection |
| Group B | Active comparator | 26 patients we planned to inject them local glucose 5% ( 10 ml glucose) directly into the carpal tunnel in (group A) Receives: Drug: Dexamethasone; Drug: Glucose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes in visual analogue scale (pre - post- and follow up)
the changes in visual analogue scale (pre - post- and follow up) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores . pain intensity described as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 14 days
Secondary outcomes (2)
-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
-U/S In the literature, four criteria are used to diagnose CTS by sonography:
- Increase in cross-sectional area at the level of the pisiform bone;
- Increase in the flattening ratio at the level of the hook of the Hamate
- Palmar bowing of the flexor retinaculum by sonography.
The above readings will be calculated and will be compared to the previous readings of the same patient of each group.
eg. The grade of CTS severity was classified according to the CSA of the median nerve considering 10.0 - 12.9mm2 as mild grade, 13.0 - 15.0mm2 as moderate grade and >15.0 mm2 as severe grade
Measured: 3 months
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
Neurophysiology studies (sensory, motor conduction, and f wave of both median and ulnar nerve)
Grade ............................................ EDX Abnormality
- Very mild CTS ............ .................. detected by only PWDSLD*
- Mild Median.................................... DML <4.5 and sensory NCV <40
- Moderately severe Median............. DML♦ >4.5 and <6.5 with preserved SNAP
- Severe Median ...............................DML >4.5 and <6.5 with absent SNAP
- Very severe Median....................... DML >6.5 with CMAP >0.2 mv
- Extremely severe Median ...............CMAP from APB <0.2 mv we detect improvment in latency, amplitude and NCV after 3 months of local injection and comparing it with previous readings of the same patient of each group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Dec 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Talaat Helmy Mohamed, Assiut University
- Investigators
- Eman MH Khedr, Study director, Assiut UniversityKhaled O Aboshaera, Study director, Assiut UniversityAml MA Tohami, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496764
- Sponsor's protocol ID
- 22151125
- Status last verified
- Aug 2022
- First submitted
- 27 Dec 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
PubMed 28075090Kamel SR, Sadek HA, Hamed A, Sayed OA, Mahmud MH, Mohamed FA, El Sagher GM, Aly LH. Ultrasound-guided insulin injection for carpal tunnel syndrome in type 2 diabetes mellitus patients. Clin Rheumatol. 2019 Oct;38(10):2933-2940. doi: 10.1007/s10067-019-04638-7. Epub 2019 Jun 17.
PubMed 31209710Ashraf A, Moghtaderi AR, Yazdani AH, Mirshams S. Evaluation of effectiveness of local insulin injection in non-insulin-dependent diabetic patient with carpal tunnel syndrome. Electromyogr Clin Neurophysiol. 2009 May-Jun;49(4):161-6.
PubMed 19534294Pourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. Diabet Med. 2016 Jan;33(1):10-6. doi: 10.1111/dme.12855. Epub 2015 Aug 18.
PubMed 26173490Nakandala, Piumi. (2019). International Journal of Advanced Research and Publications Manual Therapy Interventions For Carpal Tunnel Syndrome: A Review. 3. 88-96.
Recio-Pinto E, Rechler MM, Ishii DN. Effects of insulin, insulin-like growth factor-II, and nerve growth factor on neurite formation and survival in cultured sympathetic and sensory neurons. J Neurosci. 1986 May;6(5):1211-9. doi: 10.1523/JNEUROSCI.06-05-01211.1986.
PubMed 3519887Kanikannan MA, Boddu DB, Umamahesh, Sarva S, Durga P, Borgohain R. Comparison of high-resolution sonography and electrophysiology in the diagnosis of carpal tunnel syndrome. Ann Indian Acad Neurol. 2015 Apr-Jun;18(2):219-25. doi: 10.4103/0972-2327.150590.
PubMed 26019423Mody GN, Anderson GA, Thomas BP, Pallapati SC, Santoshi JA, Antonisamy B. Carpal tunnel syndrome in Indian patients: use of modified questionnaires for assessment. J Hand Surg Eur Vol. 2009 Oct;34(5):671-8. doi: 10.1177/1753193409101469. Epub 2009 Aug 17.
PubMed 19687086Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Arian M, Mirmohammadkhani M, Ghorbani R, Soleimani M. Health-related quality of life (HRQoL) in beta-thalassemia major (beta-TM) patients assessed by 36-item short form health survey (SF-36): a meta-analysis. Qual Life Res. 2019 Feb;28(2):321-334. doi: 10.1007/s11136-018-1986-1. Epub 2018 Sep 7.
PubMed 30194626Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
PubMed 11323136Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
PubMed 28850536Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Sharour LA, Omari OA, Salameh AB, Yehia D. Health-related quality of life among patients with colorectal cancer. J Res Nurs. 2020 Mar;25(2):114-125. doi: 10.1177/1744987119846177. Epub 2019 Aug 22.
PubMed 34394615Wong SM, Griffith JF, Hui AC, Lo SK, Fu M, Wong KS. Carpal tunnel syndrome: diagnostic usefulness of sonography. Radiology. 2004 Jul;232(1):93-9. doi: 10.1148/radiol.2321030071. Epub 2004 May 20.
PubMed 15155897
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect and Quality of Life After Local Injection of Steroid VS. Glucose 5% for Carpal Tunnel Syndrome : Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05496764
- Acronym / sponsor ID
- 22151125
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- local injection, pain relief, steroid, glucose 5%
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 11 Aug 2022 (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.
To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection.
Detailed description
Carpal tunnel syndrome (CTS) is the most prevalent type of peripheral nerve entrapment involving compression of the median nerve in the carpal tunnel. 1 This condition is more common in females than in males. CTS may be unilateral or bilateral. It is a significant cause of morbidity and poor quality of life in those patients. There is deterioration in functional outcomes and maybe psychologically as well. The severity of CTS varied from mild to moderate to severe. Its signs and symptoms include numbness along with the median nerve distribution of the hand, pain, atrophy of muscles, handgrip weakness, etc. Mild or moderate cases are usually seeking conservative treatment like electrotherapeutic modalities, manual therapy interventions, oral supplements and medications, and wrist immobilizations such as splints. Severe cases are likely to go toward surgery. But most patients with CTS are reluctant to take the surgical choice, mainly because of financial issues and secondary complications. Therefore, the evaluation of the effectiveness of the non-surgical (conservative) therapies should be a major concern, as they are cost-effective and lacks secondary complications. Much research has been conducted to see the efficacy of various conservative therapies.
-study method: We are going to carry out a double-blinded randomized, case-controlled study on 52 patients who are randomly chosen and categorized them into 2 groups, 26 patients each. we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group 1) and to inject 10 ml glucose 5% into the carpal tunnel for the other group (group 2).. All injections will be under sonographic guidance. Neurophysiology, U/S, pain scales, and quality of life scales studies will be performed for these two groups before treatment and after 12 weeks of injection. The patients will be followed up for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexamethasone, Drug: Glucose Injection26 patients we planned to inject them local steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group A) |
| Group B | Active comparator | Drug: Dexamethasone, Drug: Glucose Injection26 patients we planned to inject them local glucose 5% ( 10 ml glucose) directly into the carpal tunnel in (group A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female or male patient > 18y
- mild to moderate cases of carpal tunnel syndrome according to Bland's Neurophysiological Grading Scale for Patients with CTS
- clear consent to participate in the study
Key exclusion criteria (3 listed)
- age younger than 18y.
- severe cases of CTS.
- systemic diseases cause CTS .
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 |
|---|---|---|
| Dexamethasonewe planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in group A | Drug | Group A, Group B |
| Glucose InjectionAlso: glucose 5%inject10 ml glucose 5% into the carpal tunnel in group B | Drug | Group A, Group B |
Primary outcome
the changes in visual analogue scale (pre - post- and follow up)
Time frame: 14 days
the changes in visual analogue scale (pre - post- and follow up) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores . pain intensity described as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
2 secondary outcomes
-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
Time frame: 3 months
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 28075090Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
- Background: PubMed 31209710Kamel SR, Sadek HA, Hamed A, Sayed OA, Mahmud MH, Mohamed FA, El Sagher GM, Aly LH. Ultrasound-guided insulin injection for carpal tunnel syndrome in type 2 diabetes mellitus patients. Clin Rheumatol. 2019 Oct;38(10):2933-2940. doi: 10.1007/s10067-019-04638-7. Epub 2019 Jun 17.
- Background: PubMed 19534294Ashraf A, Moghtaderi AR, Yazdani AH, Mirshams S. Evaluation of effectiveness of local insulin injection in non-insulin-dependent diabetic patient with carpal tunnel syndrome. Electromyogr Clin Neurophysiol. 2009 May-Jun;49(4):161-6.
- Background: PubMed 26173490Pourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. Diabet Med. 2016 Jan;33(1):10-6. doi: 10.1111/dme.12855. Epub 2015 Aug 18.
- BackgroundNakandala, Piumi. (2019). International Journal of Advanced Research and Publications Manual Therapy Interventions For Carpal Tunnel Syndrome: A Review. 3. 88-96.
- Background: PubMed 3519887Recio-Pinto E, Rechler MM, Ishii DN. Effects of insulin, insulin-like growth factor-II, and nerve growth factor on neurite formation and survival in cultured sympathetic and sensory neurons. J Neurosci. 1986 May;6(5):1211-9. doi: 10.1523/JNEUROSCI.06-05-01211.1986.
- Background: PubMed 26019423Kanikannan MA, Boddu DB, Umamahesh, Sarva S, Durga P, Borgohain R. Comparison of high-resolution sonography and electrophysiology in the diagnosis of carpal tunnel syndrome. Ann Indian Acad Neurol. 2015 Apr-Jun;18(2):219-25. doi: 10.4103/0972-2327.150590.
- Background: PubMed 19687086Mody GN, Anderson GA, Thomas BP, Pallapati SC, Santoshi JA, Antonisamy B. Carpal tunnel syndrome in Indian patients: use of modified questionnaires for assessment. J Hand Surg Eur Vol. 2009 Oct;34(5):671-8. doi: 10.1177/1753193409101469. Epub 2009 Aug 17.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 30194626Arian M, Mirmohammadkhani M, Ghorbani R, Soleimani M. Health-related quality of life (HRQoL) in beta-thalassemia major (beta-TM) patients assessed by 36-item short form health survey (SF-36): a meta-analysis. Qual Life Res. 2019 Feb;28(2):321-334. doi: 10.1007/s11136-018-1986-1. Epub 2018 Sep 7.
- Background: PubMed 11323136Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
- Background: PubMed 28850536Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Eman MH Khedr study director
Assiut University
Khaled O Aboshaera study director
Assiut University
Aml MA Tohami study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Glucose Injection in people with Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed TH Mohamed, Resident (00201090117707, mohamedtalaathelmy7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes in visual analogue scale (pre - post- and follow up) (time frame: 14 days). 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 NCT05496764, which also lists 22 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 11 Aug 2022.