Low Back PainNCT06018402
The Effect of Physical Therapy Program and Erector Spina Plane Block in Patients With Degenerative Lumbar Scoliosis
A study testing physical therapy and physical therapy + espb in people with Low Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Degenerative (de novo) scoliosis is the result of a long and multifactorial process that occurs through degenerative change in the aging population without a pre-existing spinal deformity. Pain is the most important symptom and the major difference from adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- physical therapy and physical therapy + espb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 3 Jun 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 60 years or older
- Having a scoliosis of 10 degrees or more in the lumbar region according to the measurement made with the cobb method
- Having pain in the axial waist or radiating from the waist to the leg
- Pain that persists for at least 3 months
- NRS > 4
Who cannot join
- Systemic or local infection at the injection site
- Past or current history of malignant disease
- Presence of neurological or orthopedic disease
- Presence of uncontrolled hypertension, diabetes mellitus
- Presence of severe heart failure
- Presence of bleeding diathesis
Show all 14Show fewer
- Anticoagulant use
- Lidocaine allergy
- Psychiatric disorder or mental problem
- inflammatory spine pain
- Severe osteoporosis / previous vertebral fracture
- Body mass index >35
- Having had previous surgery on the lumbar region
- Injection was applied to the waist region within 6 months or physical have been treated
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Farih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
Fatih Sultan Mehmet Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Erector Spinae Plane Block in Combination With Physical Therapy on Pain, Disability, and Quality of Life in Patients With Degenerative Scoliosis: Prospective, Randomized, Clinical Study
Degenerative (de novo) scoliosis is the result of a long and multifactorial process that occurs through degenerative change in the aging population without a pre-existing spinal deformity. Pain is the most important symptom and the major difference from adolescent idiopathic scoliosis. Treatment is often complex and patient-specific. The first aim of our study is to evaluate the effectiveness of physical therapy on pain, disability and quality of life in patients with degenerative lumbar scoliosis and the second aim is to investigate whether erector spina plan block (ESPB) combined with physical therapy has an effect on the results.
Read the detailed description
Patients over 60 years of age, with low back or low back-leg pain for at least 3 months, who had received pharmacologic treatment but did not respond, and diagnosed with degenerative lumbar scoliosis are included in the study. Patients are randomized into to groups according to the interventions as: physical therapy group (G-1) and physical therapy and ESPB injection group (G-2). The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity). Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone are administered for unilateral injection. The procedure is performed bilaterallyThe primary endpoint of the study is pain intensity assasment by using a numerical rating scale (NRS), and secondary endpoints are functional status, quality of life and disability status assasment by using SRS-22 and Oswestry disability index. Patients are evaluated before and 1 week, 1 month and 3 months after treatment. In the 2nd group, pain intensity at 1 hour after injection is additionally evaluated with a NRS. As a result of the power analysis, the minimum sample size was planned as a total of 16 patients with 8 patients in each group with a 15% dropout rate. Shapiro Wilk test is applied to examine the normality of the data distribution. The difference between groups is evaluated by Mann Whitney U according to normal distribution and by ANOVA for time-dependent within-group change.
- Conditions
- Low Back Pain
- Being tested
- physical therapy, physical therapy + espb
- Keywords
- Degenerative lumbar scoliosis, Physical treatment, Erector spinae plane block, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity).
physical therapy + espbOther
the same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy | Active comparator | The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity) Receives: Other: physical therapy |
| physical therapy + espb | Active comparator | same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally. Receives: Other: physical therapy + espb |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numeric Rating Scale)
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: Day 0
NRS (Numeric Rating Scale)
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 1 hour after injection
NRS (Numeric Rating Scale)
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 1 week after physical treatment
NRS (Numeric Rating Scale)
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 1 month after physical treatment
NRS (Numeric Rating Scale)
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 3 month after physical treatment
Secondary outcomes (8)
SRS-22
22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
Measured: Day 0
SRS-22
22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
Measured: 1 week after physical treatment
SRS-22
22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
Measured: 1 month after physical treatment
SRS-22
22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
Measured: 3 month after physical treatment
Oswestry Disability Index
Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
Measured: Day 0
Oswestry Disability Index
Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
Measured: 1 week after physical treatment
Oswestry Disability Index
Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
Measured: 1 month after physical treatment
Oswestry Disability Index
Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
Measured: 3 month after physical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start15 Sep 2023
- Primary completion15 May 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Prospective, Randomised, Clinical Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Illeez, MD, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Ozge Gulsum Illeez, Study director, Fatih Sultan Mehmet Taining and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018402
- Sponsor's protocol ID
- ozgeilleez1
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.
PubMed 26945131Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
PubMed 17630141Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Ahiskalioglu A, Alici HA, Ciftci B, Celik M, Karaca O. Continuous ultrasound guided erector spinae plane block for the management of chronic pain. Anaesth Crit Care Pain Med. 2019 Aug;38(4):395-396. doi: 10.1016/j.accpm.2017.11.014. Epub 2017 Dec 15. No abstract available.
PubMed 29253539Akyuz ME, Firidin MN. Bilateral ultrasound-guided erector spinae plane block for postoperative persistent low back pain in lumbar disc surgery. Eur Spine J. 2022 Jul;31(7):1873-1878. doi: 10.1007/s00586-022-07212-z. Epub 2022 Apr 14.
PubMed 35420380Durmus IE, Surucu S, Muz A, Takmaz SA. The effectiveness of erector spinae plane block in patients with chronic low back pain. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):138-143. doi: 10.26355/eurrev_202301_30864.
PubMed 36647861
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Plane Block in Combination With Physical Therapy on Pain, Disability, and Quality of Life in Patients With Degenerative Scoliosis: Prospective, Randomized, Clinical Study
- ClinicalTrials.gov ID
- NCT06018402
- Acronym / sponsor ID
- ozgeilleez1
- Conditions
- Low Back Pain
- Keywords
- Degenerative lumbar scoliosis, Physical treatment, Erector spinae plane block, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 30 Aug 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.
Degenerative (de novo) scoliosis is the result of a long and multifactorial process that occurs through degenerative change in the aging population without a pre-existing spinal deformity. Pain is the most important symptom and the major difference from adolescent idiopathic scoliosis. Treatment is often complex and patient-specific. The first aim of our study is to evaluate the effectiveness of physical therapy on pain, disability and quality of life in patients with degenerative lumbar scoliosis and the second aim is to investigate whether erector spina plan block (ESPB) combined with physical therapy has an effect on the results.
Detailed description
Patients over 60 years of age, with low back or low back-leg pain for at least 3 months, who had received pharmacologic treatment but did not respond, and diagnosed with degenerative lumbar scoliosis are included in the study. Patients are randomized into to groups according to the interventions as: physical therapy group (G-1) and physical therapy and ESPB injection group (G-2). The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity). Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone are administered for unilateral injection. The procedure is performed bilaterallyThe primary endpoint of the study is pain intensity assasment by using a numerical rating scale (NRS), and secondary endpoints are functional status, quality of life and disability status assasment by using SRS-22 and Oswestry disability index. Patients are evaluated before and 1 week, 1 month and 3 months after treatment. In the 2nd group, pain intensity at 1 hour after injection is additionally evaluated with a NRS. As a result of the power analysis, the minimum sample size was planned as a total of 16 patients with 8 patients in each group with a 15% dropout rate. Shapiro Wilk test is applied to examine the normality of the data distribution. The difference between groups is evaluated by Mann Whitney U according to normal distribution and by ANOVA for time-dependent within-group change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomised, Clinical Study
| Arm | Type | Receives |
|---|---|---|
| physical therapy | Active comparator | Other: physical therapyThe physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity) |
| physical therapy + espb | Active comparator | Other: physical therapy + espbsame physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 60 years or older
- Having a scoliosis of 10 degrees or more in the lumbar region according to the measurement made with the cobb method
- Having pain in the axial waist or radiating from the waist to the leg
- Pain that persists for at least 3 months
- NRS > 4
Key exclusion criteria (14 listed)
- Systemic or local infection at the injection site
- Past or current history of malignant disease
- Presence of neurological or orthopedic disease
- Presence of uncontrolled hypertension, diabetes mellitus
- Presence of severe heart failure
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 |
|---|---|---|
| physical therapyThe physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity). | Other | physical therapy |
| physical therapy + espbthe same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally. | Other | physical therapy + espb |
Primary outcome
NRS (Numeric Rating Scale)
Time frame: Day 0
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
NRS (Numeric Rating Scale)
Time frame: 1 hour after injection
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
NRS (Numeric Rating Scale)
Time frame: 1 week after physical treatment
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
NRS (Numeric Rating Scale)
Time frame: 1 month after physical treatment
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
NRS (Numeric Rating Scale)
Time frame: 3 month after physical treatment
Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
8 secondary outcomes
SRS-22
Time frame: Day 0
SRS-22
Time frame: 1 week after physical treatment
SRS-22
Time frame: 1 month after physical treatment
SRS-22
Time frame: 3 month after physical treatment
Oswestry Disability Index
Time frame: Day 0
Oswestry Disability Index
Time frame: 1 week after physical treatment
Oswestry Disability Index
Time frame: 1 month after physical treatment
Oswestry Disability Index
Time frame: 3 month after physical treatment
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 Jun 2025.
- Background: PubMed 26945131Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.
- Background: PubMed 17630141Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 29253539Ahiskalioglu A, Alici HA, Ciftci B, Celik M, Karaca O. Continuous ultrasound guided erector spinae plane block for the management of chronic pain. Anaesth Crit Care Pain Med. 2019 Aug;38(4):395-396. doi: 10.1016/j.accpm.2017.11.014. Epub 2017 Dec 15. No abstract available.
- Background: PubMed 35420380Akyuz ME, Firidin MN. Bilateral ultrasound-guided erector spinae plane block for postoperative persistent low back pain in lumbar disc surgery. Eur Spine J. 2022 Jul;31(7):1873-1878. doi: 10.1007/s00586-022-07212-z. Epub 2022 Apr 14.
- Background: PubMed 36647861Durmus IE, Surucu S, Muz A, Takmaz SA. The effectiveness of erector spinae plane block in patients with chronic low back pain. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):138-143. doi: 10.26355/eurrev_202301_30864.
- 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.
Ozge Gulsum Illeez study director
Fatih Sultan Mehmet Taining and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy and physical therapy + espb in people with Low Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 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 Jun 2025. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (Numeric Rating Scale) (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018402, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.