ThoracicNCT05395078
Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain
A study testing Conventional physical therapy treatment along with thoracic extension exercises and Conventional physical therapy treatment along with thoracic stabilization exercises in people with Thoracic, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effects of thoracic extension versus thoracic stabilization exercises on pain, stiffness, range of motion, disability and posture in patients with Maigne's thoracic pain.This study will be a randomized clinical trial and 32 patients fulfilling the inclusion criteria will be… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Thoracic
- What is being tested?
- Conventional physical therapy treatment along with thoracic extension exercises and Conventional physical therapy treatment along with thoracic stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of age between 20-45 years
- NPRS value more than or equal to 4
- Cobb's Angle > 40°
- Chronic Maigne's Thoracic pain
Who cannot join
- Structural abnormalities
- Neoplasm
- Neurogenic problem
- H/o cervical or thoracic surgery
- H/o whiplash injury
- Muscular strain
- Lactating mothers
- Pregnant or 6 months post-partum females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Thoracic Extension Versus Thoracic Stabilization Exercises on Pain, Stiffness, Range of Motion, Disability and Posture in Patients With Maigne's Thoracic Pain.
The aim of this study is to compare the effects of thoracic extension versus thoracic stabilization exercises on pain, stiffness, range of motion, disability and posture in patients with Maigne's thoracic pain.This study will be a randomized clinical trial and 32 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Group A will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Extension exercise program, while Group B will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Stabilization exercise program. Outcome measure: Numeric Pain Rating Scale, Goniometer, Thoracic Stiffness Index, Revised Oswestry Thoracic Pain Disability Questionnaire, standing thoracic X-ray and Flexi curve ruler, will measure pain, thoracic flexion and extension, Cobb's angle, kyphosis index, thoracic stiffness index and disability. Both groups will receive a total of 45 minutes session, thrice a week for 3 weeks. Measurements will be taken at the baseline, at the end of 3rd week and for long-term effects at the end of 6th week. Data will be analyzed by SPSS version 21.
Read the detailed description
Maigne's thoracic pain is a condition in which pain originates from the thoracic spine, but according to Maigne, in most cases, its origin lies in the lower three cervical segments. It is common among both men and women, but it is most common among women. Common symptoms of Maigne's thoracic pain are tenderness and stiffness of thoracic muscles, especially interscapular muscles. The most important and chief complaint reported by patients of this condition is unilateral and severe pain which increases with static sitting and with carrying or lifting heavyweight. Physical examination of tenderness on the interscapular region at the level of T5-T6, 1-2 cm lateral to the midline. Pressure reproduces the patient's pain. Several clinical trials have established therapeutic guidelines and protocols for the rehabilitation of hyperkyphosis. These trials have typically focused on the use of spinal bracing, therapeutic taping, manual therapy, and therapeutic exercise for postural training. Studies have been conducted on the effectiveness of combination therapy of thoracic extension exercises with other therapeutic exercises. Similarly, many studies have been conducted on thoracic stabilization exercises for posture correction. It is quite difficult to judge which exercise is more effective than the other. Moreover, typically for the management of Maigne's Thoracic pain, the efficacy of therapeutic treatment is quite underexplored. The rationale of this study is that it will provide evidence that may improve treatment strategies for the management of Maigne's Thoracic pain, majorly focusing on the muscular component of the thoracic region.
- Conditions
- Thoracic
- Being tested
- Conventional physical therapy treatment along with thoracic extension exercises, Conventional physical therapy treatment along with thoracic stabilization exercises
- Keywords
- Magnie's thoracic pain, Hyperkyphosis, Thoracic stabilization, Extension exercises
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy treatment along with thoracic extension exercisesOther
Thoracic Extension Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic spine extension and trunk muscle flexibility. A specialized program of thoracic extension in sitting, in prone lying, in quadruped position, on foam roller, wall angle stretch, corner stretch + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). A total of 45 minutes session three times a week on alternate days for 3 weeks.
Assessment will be done at baseline, on the end of 3rd week and for long term effects at the end of 6th week.
Conventional physical therapy treatment along with thoracic stabilization exercisesOther
Thoracic Stabilization Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic musculature, static and dynamic thoracic posture. A specialized program of Draw- in and chin tucks in crook lying, prone, sitting and standing, prone chin- tuck elevation exercises with arm at sides, arms behind head or overhead (4) + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long term effects at the end of 6th week.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Thoracic extension exercises Receives: Other: Conventional physical therapy treatment along with thoracic extension exercises |
| Group B | Experimental | Thoracic Stabilization exercises Receives: Other: Conventional physical therapy treatment along with thoracic stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Measured: 3rd Week
Goniometer
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Thoracic flexion and extension will be assessed through it.
Measured: 3rd Week
Standing Thoracic X-ray
One lateral view X-ray of each subject will be taken of the thoracic spine at the hospital radiography department. Subjects will stand in a relaxed position with arms elevated in front of them for the X-ray. Cobb's angle will be measured from X-ray.
Measured: 3rd Week
Kyphosis Index (KI)
Kyphosis Index will be measured using Flexi curve ruler, which is a flexible plastic 60-cm ruler to evaluate surface contour of thoracic curvature. The KI will be calculated by multiplying 100 by the value of thoracic width divided by thoracic length or KI = (thoracic width/length) ×100.
Measured: 3rd Week
Thoracic Stiffness Index (TSI):
The TSI will be calculated as the value of the:
KI in relaxed posture divided by the KI in best posture.
Measured: 3rd Week
Revised Oswestry Thoracic Pain Disability Questionnaire (ROTPDQ)
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
Measured: 3rd Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395078
- Sponsor's protocol ID
- REC/RCR &AHS/22/0134 Rubab
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jain A, Srivastava D, Mishra A. Effects of targeted back muscle exercises in reducing thoracic kyphosis in patients of hyperkyphosis. International Journal of Orthopaedics. 2020;6(4):885-90.
Almujel KN, Almhmd AE, Alharfy AAN, Albalawi IAS, Alanazi TBF, Alshehri AJ, et al. Causes and Management of Hyperkyphosis. Journal of Pharmaceutical Research International, July. 2021:1-8.
Jang HJ, Hughes LC, Oh DW, Kim SY. Effects of Corrective Exercise for Thoracic Hyperkyphosis on Posture, Balance, and Well-Being in Older Women: A Double-Blind, Group-Matched Design. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):E17-E27. doi: 10.1519/JPT.0000000000000146.
PubMed 28914720Dutton M, Magee D, Hengeveld E, Banks K, Atkinson K, Coutts F, et al. Orthopaedic examination, evaluation, and intervention: McGraw-Hill Medical; 2004.
Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004 Mar;83(3):177-86. doi: 10.1097/01.phm.0000113403.16617.93.
PubMed 15043351Bautmans I, Van Arken J, Van Mackelenberg M, Mets T. Rehabilitation using manual mobilization for thoracic kyphosis in elderly postmenopausal patients with osteoporosis. J Rehabil Med. 2010 Feb;42(2):129-35. doi: 10.2340/16501977-0486.
PubMed 20140408Greig AM, Bennell KL, Briggs AM, Hodges PW. Postural taping decreases thoracic kyphosis but does not influence trunk muscle electromyographic activity or balance in women with osteoporosis. Man Ther. 2008 Jun;13(3):249-57. doi: 10.1016/j.math.2007.01.011. Epub 2007 Apr 12.
PubMed 17433756Kang NY, Im SC, Kim K. Effects of a combination of scapular stabilization and thoracic extension exercises for office workers with forward head posture on the craniovertebral angle, respiration, pain, and disability: A randomized-controlled trial. Turk J Phys Med Rehabil. 2021 Sep 1;67(3):291-299. doi: 10.5606/tftrd.2021.6397. eCollection 2021 Sep.
PubMed 34870115Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.
PubMed 28425239Piri H, Hajian M, Mirkarimpour SH, Sheikhhoseini R, Rahimi M. The Effect of 12-Week Corrective Exercises on the Postural Angles of Beautician Females with Upper Crossed Syndrome: a Clinical Trial Study. Women's Health Bulletin. 2021:63-70.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Extension Versus Thoracic Stabilization Exercises on Pain, Stiffness, Range of Motion, Disability and Posture in Patients With Maigne's Thoracic Pain.
- ClinicalTrials.gov ID
- NCT05395078
- Acronym / sponsor ID
- REC/RCR &AHS/22/0134 Rubab
- Conditions
- Thoracic
- Keywords
- Magnie's thoracic pain, Hyperkyphosis, Thoracic stabilization, Extension exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 May 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.
The aim of this study is to compare the effects of thoracic extension versus thoracic stabilization exercises on pain, stiffness, range of motion, disability and posture in patients with Maigne's thoracic pain.This study will be a randomized clinical trial and 32 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Group A will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Extension exercise program, while Group B will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Stabilization exercise program. Outcome measure: Numeric Pain Rating Scale, Goniometer, Thoracic Stiffness Index, Revised Oswestry Thoracic Pain Disability Questionnaire, standing thoracic X-ray and Flexi curve ruler, will measure pain, thoracic flexion and extension, Cobb's angle, kyphosis index, thoracic stiffness index and disability. Both groups will receive a total of 45 minutes session, thrice a week for 3 weeks. Measurements will be taken at the baseline, at the end of 3rd week and for long-term effects at the end of 6th week. Data will be analyzed by SPSS version 21.
Detailed description
Maigne's thoracic pain is a condition in which pain originates from the thoracic spine, but according to Maigne, in most cases, its origin lies in the lower three cervical segments. It is common among both men and women, but it is most common among women. Common symptoms of Maigne's thoracic pain are tenderness and stiffness of thoracic muscles, especially interscapular muscles. The most important and chief complaint reported by patients of this condition is unilateral and severe pain which increases with static sitting and with carrying or lifting heavyweight. Physical examination of tenderness on the interscapular region at the level of T5-T6, 1-2 cm lateral to the midline. Pressure reproduces the patient's pain. Several clinical trials have established therapeutic guidelines and protocols for the rehabilitation of hyperkyphosis. These trials have typically focused on the use of spinal bracing, therapeutic taping, manual therapy, and therapeutic exercise for postural training. Studies have been conducted on the effectiveness of combination therapy of thoracic extension exercises with other therapeutic exercises. Similarly, many studies have been conducted on thoracic stabilization exercises for posture correction. It is quite difficult to judge which exercise is more effective than the other. Moreover, typically for the management of Maigne's Thoracic pain, the efficacy of therapeutic treatment is quite underexplored. The rationale of this study is that it will provide evidence that may improve treatment strategies for the management of Maigne's Thoracic pain, majorly focusing on the muscular component of the thoracic region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Conventional physical therapy treatment along with thoracic extension exercisesThoracic extension exercises |
| Group B | Experimental | Other: Conventional physical therapy treatment along with thoracic stabilization exercisesThoracic Stabilization exercises |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of age between 20-45 years
- NPRS value more than or equal to 4
- Cobb's Angle > 40°
- Chronic Maigne's Thoracic pain
Key exclusion criteria (8 listed)
- Structural abnormalities
- Neoplasm
- Neurogenic problem
- H/o cervical or thoracic surgery
- H/o whiplash injury
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 |
|---|---|---|
| Conventional physical therapy treatment along with thoracic extension exercisesThoracic Extension Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic spine extension and trunk muscle flexibility. A specialized program of thoracic extension in sitting, in prone lying, in quadruped position, on foam roller, wall angle stretch, corner stretch + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long term effects at the end of 6th week. | Other | Group A |
| Conventional physical therapy treatment along with thoracic stabilization exercisesThoracic Stabilization Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic musculature, static and dynamic thoracic posture. A specialized program of Draw- in and chin tucks in crook lying, prone, sitting and standing, prone chin- tuck elevation exercises with arm at sides, arms behind head or overhead (4) + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long term effects at the end of 6th week. | Other | Group B |
Primary outcome
NPRS
Time frame: 3rd Week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Goniometer
Time frame: 3rd Week
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Thoracic flexion and extension will be assessed through it.
Standing Thoracic X-ray
Time frame: 3rd Week
One lateral view X-ray of each subject will be taken of the thoracic spine at the hospital radiography department. Subjects will stand in a relaxed position with arms elevated in front of them for the X-ray. Cobb's angle will be measured from X-ray.
Kyphosis Index (KI)
Time frame: 3rd Week
Kyphosis Index will be measured using Flexi curve ruler, which is a flexible plastic 60-cm ruler to evaluate surface contour of thoracic curvature. The KI will be calculated by multiplying 100 by the value of thoracic width divided by thoracic length or KI = (thoracic width/length) ×100.
Thoracic Stiffness Index (TSI):
Time frame: 3rd Week
The TSI will be calculated as the value of the: KI in relaxed posture divided by the KI in best posture.
Revised Oswestry Thoracic Pain Disability Questionnaire (ROTPDQ)
Time frame: 3rd Week
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
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 3 Apr 2023.
- BackgroundJain A, Srivastava D, Mishra A. Effects of targeted back muscle exercises in reducing thoracic kyphosis in patients of hyperkyphosis. International Journal of Orthopaedics. 2020;6(4):885-90.
- BackgroundAlmujel KN, Almhmd AE, Alharfy AAN, Albalawi IAS, Alanazi TBF, Alshehri AJ, et al. Causes and Management of Hyperkyphosis. Journal of Pharmaceutical Research International, July. 2021:1-8.
- Background: PubMed 28914720Jang HJ, Hughes LC, Oh DW, Kim SY. Effects of Corrective Exercise for Thoracic Hyperkyphosis on Posture, Balance, and Well-Being in Older Women: A Double-Blind, Group-Matched Design. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):E17-E27. doi: 10.1519/JPT.0000000000000146.
- BackgroundDutton M, Magee D, Hengeveld E, Banks K, Atkinson K, Coutts F, et al. Orthopaedic examination, evaluation, and intervention: McGraw-Hill Medical; 2004.
- Background: PubMed 15043351Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004 Mar;83(3):177-86. doi: 10.1097/01.phm.0000113403.16617.93.
- Background: PubMed 20140408Bautmans I, Van Arken J, Van Mackelenberg M, Mets T. Rehabilitation using manual mobilization for thoracic kyphosis in elderly postmenopausal patients with osteoporosis. J Rehabil Med. 2010 Feb;42(2):129-35. doi: 10.2340/16501977-0486.
- Background: PubMed 17433756Greig AM, Bennell KL, Briggs AM, Hodges PW. Postural taping decreases thoracic kyphosis but does not influence trunk muscle electromyographic activity or balance in women with osteoporosis. Man Ther. 2008 Jun;13(3):249-57. doi: 10.1016/j.math.2007.01.011. Epub 2007 Apr 12.
- Background: PubMed 34870115Kang NY, Im SC, Kim K. Effects of a combination of scapular stabilization and thoracic extension exercises for office workers with forward head posture on the craniovertebral angle, respiration, pain, and disability: A randomized-controlled trial. Turk J Phys Med Rehabil. 2021 Sep 1;67(3):291-299. doi: 10.5606/tftrd.2021.6397. eCollection 2021 Sep.
- Background: PubMed 28425239Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.
- BackgroundPiri H, Hajian M, Mirkarimpour SH, Sheikhhoseini R, Rahimi M. The Effect of 12-Week Corrective Exercises on the Postural Angles of Beautician Females with Upper Crossed Syndrome: a Clinical Trial Study. Women's Health Bulletin. 2021:63-70.
- 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.
Syed Shakil-ur Rehman 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 Conventional physical therapy treatment along with thoracic extension exercises and Conventional physical therapy treatment along with thoracic stabilization exercises in people with Thoracic, 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 4 inclusion and 8 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 3 Apr 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?
NPRS (time frame: 3rd Week). The study lists 6 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 NCT05395078, which also lists 10 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 3 Apr 2023.