Mechanical Low Back PainNCT05877469
Effects of MAT Pilates Versus Functional Training on Mechanical Low Back Pain
A study testing Mat pilates Training and Functional Training in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized clinical trial. Total 44 Subjects with mechanical low back pain will be assigned randomly by using non probability convenient random sampling in to two groups with 22 subjects in each group. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Mat pilates Training and Functional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 1 Aug 2023
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female
- Age group 25-40
- Patient having mechanical low back pain for more than 12 weeks
Who cannot join
- Pregnancy
- Previous spinal surgery
- Orthopedic and neurological diseases
- Patients with serious spinal pathologies( tumor, fracture and autoimmune conditions)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Headquarter Hospital Sahiwal
Sahiwal, Punjab Province, 57000
About this study
Official title: Effects of Mat Pilates Versus Functional Training on Pain, Range of Motion and Disability in Mechanical Low Back Pain
This study will be a randomized clinical trial. Total 44 Subjects with mechanical low back pain will be assigned randomly by using non probability convenient random sampling in to two groups with 22 subjects in each group. Subjects in one group will be treated with mat Pilates training and the other group with the functional training. NPRS, Inclinometer and urdu version of Modified Oswestry Disablility questionair would be used to measure the outcome of pain, Range of Motion and Disability respectively. After data collection from defined study setting, data will be entered and analyzed at Riphah International University lahore.
Read the detailed description
Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. This includes lumbosacral muscle strain, disk herniation, lumbar spondylosis, spondylolisthesis, spondylolysis, vertebral compression fractures, and acute or chronic traumatic injury. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Pilates focus is improving the core strength, it trains the body as an integrated whole. Functional training involves the daily life activities that also targets on core stability and strength.
The aim of the study is to present the current state of knowledge concerning the application of pilates and functional training in terms of duration, frequency and specific exercises in the management of mechanical low back pain in terms of pain, ROM and disability improvement.
Effects of Mat Pilates and functional training on mechanical low back pain are checked individually before but their effects are not compared previously.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Mat pilates Training, Functional Training
- Keywords
- Disability, pilates Training, Range of motion, Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat pilates TrainingOther
In this group 22 patients will perform mat pilates training. Patients will be asked to stay comfortable while performing mat pilates exercies that involve different types of movements of whole body like leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, roll down and crisscross to improve the core strength. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.
Functional TrainingOther
In this group 22 patients will perform functional training. Patients will be instructed to perform their daily living movements like squatting, reaching, or even carrying a heavy object. These exercises typically use the whole body and emphasize core strength and stability. Functional training typically uses weight-bearing activities that work the core muscles in the torso. the functional movements include involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet and squats. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| mat pilates training group | Active comparator | Mat pilates training involve leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, swan dive, hovers, roll down, crisscross and planks. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. Receives: Other: Mat pilates Training |
| Functional training group | Experimental | Functional training involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet squats and woodchop. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. Receives: Other: Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry LBP disability index
MODI consists of 10 items questioning daily life activities. These are; pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and pain. There are 6 options between 0-5 points for each item. Zero indicates mild case, 5 indicates worst case, 0-14 weak, 15-29 moderate, 30 above the functional limit
Measured: 3 weeks
Numeric Pain Rating Scale
NPRS consists of a scale with 0-10 readings. The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain.
Measured: 3 weeks
Inclinometer
Inclinometer is used to measure range of motion of lumber flexion, extension and left/Right side bending
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877469
- Sponsor's protocol ID
- REC//23/0107/Wasifa Haider
- Status last verified
- Sep 2023
- First submitted
- 18 May 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
PubMed 30252425Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.
PubMed 33591367Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
PubMed 30854609Yalfani A, Raeisi Z, Koumasian Z. Effects of eight-week water versus mat pilates on female patients with chronic nonspecific low back pain: Double-blind randomized clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):70-75. doi: 10.1016/j.jbmt.2020.06.002. Epub 2020 Jun 27.
PubMed 33218568Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.
PubMed 30588084Cortell-Tormo JM, Sanchez PT, Chulvi-Medrano I, Tortosa-Martinez J, Manchado-Lopez C, Llana-Belloch S, Perez-Soriano P. Effects of functional resistance training on fitness and quality of life in females with chronic nonspecific low-back pain. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):95-105. doi: 10.3233/BMR-169684.
PubMed 28826168Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.
PubMed 33386201O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
PubMed 31630089Eliks M, Zgorzalewicz-Stachowiak M, Zenczak-Praga K. Application of Pilates-based exercises in the treatment of chronic non-specific low back pain: state of the art. Postgrad Med J. 2019 Jan;95(1119):41-45. doi: 10.1136/postgradmedj-2018-135920. Epub 2019 Jan 12.
PubMed 30636192Tsauo JY, Chen WH, Liang HW, Jang Y. The effectiveness of a functional training programme for patients with chronic low back pain--a pilot study. Disabil Rehabil. 2009;31(13):1100-6. doi: 10.1080/09638280802511047.
PubMed 19802926Amaral DDV, Miyamoto GC, Franco KFM, Dos Santos Franco YR, Bastos De Oliveira NT, Hancock MJ, Van Tulder MW, Nunes Cabral CM. Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet. J Orthop Sports Phys Ther. 2020 Apr;50(4):189-197. doi: 10.2519/jospt.2019.8839. Epub 2019 Aug 23.
PubMed 31443627Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
PubMed 33781267Neeley DK, George SZ, Minick K, Snow G, Brennan G. Four Variables Were Sufficient for Low Back Pain: Determining Which Patient-Reported Tools Pain and Disability Improvements. J Orthop Sports Phys Ther. 2022 Oct;52(10):685-693. doi: 10.2519/jospt.2022.11018. Epub 2022 Aug 12.
PubMed 35960508Sedrez JA, Furlanetto TS, Gelain GM, Candotti CT. Validity and Reliability of Smartphones in Assessing Spinal Kinematics: A Systematic Review and Meta-analysis. J Manipulative Physiol Ther. 2020 Jul-Aug;43(6):635-645. doi: 10.1016/j.jmpt.2019.10.012. Epub 2020 Sep 6.
PubMed 32900546
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mat Pilates Versus Functional Training on Pain, Range of Motion and Disability in Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05877469
- Acronym / sponsor ID
- REC//23/0107/Wasifa Haider
- Conditions
- Mechanical Low Back Pain
- Keywords
- Disability, pilates Training, Range of motion, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 May 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.
This study will be a randomized clinical trial. Total 44 Subjects with mechanical low back pain will be assigned randomly by using non probability convenient random sampling in to two groups with 22 subjects in each group. Subjects in one group will be treated with mat Pilates training and the other group with the functional training. NPRS, Inclinometer and urdu version of Modified Oswestry Disablility questionair would be used to measure the outcome of pain, Range of Motion and Disability respectively. After data collection from defined study setting, data will be entered and analyzed at Riphah International University lahore.
Detailed description
Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. This includes lumbosacral muscle strain, disk herniation, lumbar spondylosis, spondylolisthesis, spondylolysis, vertebral compression fractures, and acute or chronic traumatic injury. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Pilates focus is improving the core strength, it trains the body as an integrated whole. Functional training involves the daily life activities that also targets on core stability and strength.
The aim of the study is to present the current state of knowledge concerning the application of pilates and functional training in terms of duration, frequency and specific exercises in the management of mechanical low back pain in terms of pain, ROM and disability improvement.
Effects of Mat Pilates and functional training on mechanical low back pain are checked individually before but their effects are not compared previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mat pilates training group | Active comparator | Other: Mat pilates TrainingMat pilates training involve leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, swan dive, hovers, roll down, crisscross and planks. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. |
| Functional training group | Experimental | Other: Functional TrainingFunctional training involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet squats and woodchop. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both male and female
- Age group 25-40
- Patient having mechanical low back pain for more than 12 weeks
Key exclusion criteria (4 listed)
- Pregnancy
- Previous spinal surgery
- Orthopedic and neurological diseases
- Patients with serious spinal pathologies( tumor, fracture and autoimmune conditions)
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 |
|---|---|---|
| Mat pilates TrainingIn this group 22 patients will perform mat pilates training. Patients will be asked to stay comfortable while performing mat pilates exercies that involve different types of movements of whole body like leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, roll down and crisscross to improve the core strength. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. | Other | mat pilates training group |
| Functional TrainingIn this group 22 patients will perform functional training. Patients will be instructed to perform their daily living movements like squatting, reaching, or even carrying a heavy object. These exercises typically use the whole body and emphasize core strength and stability. Functional training typically uses weight-bearing activities that work the core muscles in the torso. the functional movements include involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet and squats. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks. | Other | Functional training group |
Primary outcome
Modified Oswestry LBP disability index
Time frame: 3 weeks
MODI consists of 10 items questioning daily life activities. These are; pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and pain. There are 6 options between 0-5 points for each item. Zero indicates mild case, 5 indicates worst case, 0-14 weak, 15-29 moderate, 30 above the functional limit
Numeric Pain Rating Scale
Time frame: 3 weeks
NPRS consists of a scale with 0-10 readings. The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain.
Inclinometer
Time frame: 3 weeks
Inclinometer is used to measure range of motion of lumber flexion, extension and left/Right side bending
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 25 Sep 2023.
- Background: PubMed 30252425Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- Background: PubMed 33591367Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.
- Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- Background: PubMed 30854609Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
- Background: PubMed 33218568Yalfani A, Raeisi Z, Koumasian Z. Effects of eight-week water versus mat pilates on female patients with chronic nonspecific low back pain: Double-blind randomized clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):70-75. doi: 10.1016/j.jbmt.2020.06.002. Epub 2020 Jun 27.
- Background: PubMed 30588084Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.
- Background: PubMed 28826168Cortell-Tormo JM, Sanchez PT, Chulvi-Medrano I, Tortosa-Martinez J, Manchado-Lopez C, Llana-Belloch S, Perez-Soriano P. Effects of functional resistance training on fitness and quality of life in females with chronic nonspecific low-back pain. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):95-105. doi: 10.3233/BMR-169684.
- Background: PubMed 33386201Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.
- Background: PubMed 31630089O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
- Background: PubMed 30636192Eliks M, Zgorzalewicz-Stachowiak M, Zenczak-Praga K. Application of Pilates-based exercises in the treatment of chronic non-specific low back pain: state of the art. Postgrad Med J. 2019 Jan;95(1119):41-45. doi: 10.1136/postgradmedj-2018-135920. Epub 2019 Jan 12.
- Background: PubMed 19802926Tsauo JY, Chen WH, Liang HW, Jang Y. The effectiveness of a functional training programme for patients with chronic low back pain--a pilot study. Disabil Rehabil. 2009;31(13):1100-6. doi: 10.1080/09638280802511047.
- Background: PubMed 31443627Amaral DDV, Miyamoto GC, Franco KFM, Dos Santos Franco YR, Bastos De Oliveira NT, Hancock MJ, Van Tulder MW, Nunes Cabral CM. Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet. J Orthop Sports Phys Ther. 2020 Apr;50(4):189-197. doi: 10.2519/jospt.2019.8839. Epub 2019 Aug 23.
- 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.
Muhammad sanaullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mat pilates Training and Functional Training in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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 4 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 25 Sep 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 Pakistan. 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?
Modified Oswestry LBP disability index (time frame: 3 weeks). The study lists 3 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 NCT05877469, which also lists 15 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 25 Sep 2023.