Muscle WeaknessNCT06534931
Effects of a Thoracic Manipulation on Hip Adductor, Extensor, and Latissimus Dorsi Force in Those With Adductor Weakness
A study testing High velocity low amplitude thoracic spine manipulation in people with Muscle Weakness, run by University of New England at 1 site in United States.
Trial summary
The goal of this trial was to determine if a mid-thoracic high velocity low amplitude spinal manipulation improves force output in those with unilateral hip adductor weakness. The main aims were to determine if the intervention: Improved hip adductor force and muscle activation immediately and 48 h post manipulation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- High velocity low amplitude thoracic spine manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 13 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral hip adductor weakness, as assessed by manual muscle testing
- Pain free hip motion
- No contraindications to high velocity thoracic spine manipulation including:
- Any known active cancer/ Metastatic Bone Cancer Osteoporosis or other metabolic bone disorders Signs of spinal cord compression Nerve root compression with increasing neurologic deficit Signs of Vertebrobasilar insufficiency/ cervical artery abnormalities Bleeding Diatheses Angina pectoris
Who cannot join
- Current pain in the adductor muscle group
- Past history of hip surgery
- Past history of hip fracture
- History of spine or rib fractures
- Psoas muscle group (hip flexor) weakness as determined by manual muscle testing
- Received a chiropractic manipulation in past week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a High Velocity Low Amplitude Mid-Thoracic Spinal Segment Manipulation on the Force Output of the Hip Adductors and Extensors and the Latissimus Dorsi in Healthy Individuals With Unilateral Hip Adductor Weakness
The goal of this trial was to determine if a mid-thoracic high velocity low amplitude spinal manipulation improves force output in those with unilateral hip adductor weakness. The main aims were to determine if the intervention:
Improved hip adductor force and muscle activation immediately and 48 h post manipulation compared to a control group.
Read more
Improved gluteus maximus and latissimus dorsi force and muscle activation immediately and 48 h post manipulation compared to a control group.
Strength and muscle activation of the hip adductors, hip extensors (gluteus maximus), and shoulder extensors (latissimus dorsi) were measured prior to, immediate after, and 48 hours after receiving a high velocity low amplitude manipulation to the thoracic spine. The manipulation was performed by a licensed chiropractor.
A control group received a validated sham manipulation to the thoracic spine. Participants were blinded to group assignment.
- Conditions
- Muscle Weakness
- Being tested
- High velocity low amplitude thoracic spine manipulation, Sham
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity low amplitude thoracic spine manipulationProcedure or surgery
Participants were supine on a treatment table. The chiropractor determined levels of apparent spinal dysfunction by means of static palpation. Participants were then asked to curl forward and bring their knees to their chest as the chiropractor placed a fist just inferior to the targeted level, anywhere between the T4 - T10 vertebrae. The participant was instructed to inhale and then exhale, at which point the chiropractor lowered the participant's torso back to the table and delivered a thrust using his body into his fist.
ShamProcedure or surgery
A previously validated physiologically inert manual procedure to the thoracic spine
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | Those in the intervention group received a high velocity low amplitude manipulation to the mid-thoracic spine provided by a licensed chiropractor. Receives: Procedure: High velocity low amplitude thoracic spine manipulation |
| Sham | Sham comparator | Those in the control group received a validated sham manipulation to the mid-thoracic spine. The sham manipulation was done so that there was minimal downward force applied to the spine. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip adductor force (weak limb)
Isometric force produced by the hip adductors in the weaker limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Hip adductor muscle activity (weak limb)
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
Measured: Pre intervention, immediatly post intervention
Secondary outcomes (10)
Hip extension force (strong limb)
Isometric force produced by the hip extensors in the strong limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Gluteus maximus muscle activity (strong limb)
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
Measured: Pre intervention, immediatly post intervention
Hip extension force (weak limb)
Isometric force produced by the hip extensors in the weak limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Gluteus maximus muscle activity (weak limb)
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
Measured: Pre intervention, immediatly post intervention
Shoulder extension force (weak limb)
Isometric force produced by the shoulder extensors in the weak limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Latissimus dorsi muscle activity (weak limb)
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
Measured: Pre intervention, immediatly post intervention
Shoulder extension force (strong limb)
Isometric force produced by the shoulder extensors in the strong limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Latissimus dorsi muscle activity (strong limb)
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
Measured: Pre intervention, immediatly post intervention
Hip adductor muscle activity (strong limb)
Mean muscle activity during isometric contraction. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention
Hip adductor force (strong limb)
Isometric force produced by the hip adductors in the strong limb. Measured with a force transducer and reported in Newtons.
Measured: Pre intervention, immediatly post intervention, 48 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start8 Nov 2021
- Primary completion13 Dec 2023
- Study completion13 Dec 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 Muscle WeaknessStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Raymond Chiropractic
- Responsible party
- Principal investigator, Michael Lawrence, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534931
- Sponsor's protocol ID
- ThoracicManip
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haavik H, Kumari N, Holt K, Niazi IK, Amjad I, Pujari AN, Turker KS, Murphy B. The contemporary model of vertebral column joint dysfunction and impact of high-velocity, low-amplitude controlled vertebral thrusts on neuromuscular function. Eur J Appl Physiol. 2021 Oct;121(10):2675-2720. doi: 10.1007/s00421-021-04727-z. Epub 2021 Jun 23.
PubMed 34164712Christiansen TL, Niazi IK, Holt K, Nedergaard RW, Duehr J, Allen K, Marshall P, Turker KS, Hartvigsen J, Haavik H. The effects of a single session of spinal manipulation on strength and cortical drive in athletes. Eur J Appl Physiol. 2018 Apr;118(4):737-749. doi: 10.1007/s00421-018-3799-x. Epub 2018 Jan 11.
PubMed 29327170Holt K, Niazi IK, Nedergaard RW, Duehr J, Amjad I, Shafique M, Anwar MN, Ndetan H, Turker KS, Haavik H. The effects of a single session of chiropractic care on strength, cortical drive, and spinal excitability in stroke patients. Sci Rep. 2019 Feb 25;9(1):2673. doi: 10.1038/s41598-019-39577-5.
PubMed 30804399Niazi IK, Kamavuako EN, Holt K, Janjua TAM, Kumari N, Amjad I, Haavik H. The Effect of Spinal Manipulation on the Electrophysiological and Metabolic Properties of the Tibialis Anterior Muscle. Healthcare (Basel). 2020 Dec 10;8(4):548. doi: 10.3390/healthcare8040548.
PubMed 33321904Niazi IK, Turker KS, Flavel S, Kinget M, Duehr J, Haavik H. Changes in H-reflex and V-waves following spinal manipulation. Exp Brain Res. 2015 Apr;233(4):1165-73. doi: 10.1007/s00221-014-4193-5. Epub 2015 Jan 13.
PubMed 25579661Chilibeck PD, Cornish SM, Schulte A, Jantz N, Magnus CR, Schwanbeck S, Juurlink BH. The effect of spinal manipulation on imbalances in leg strength. J Can Chiropr Assoc. 2011 Sep;55(3):183-92.
PubMed 21886280Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.
PubMed 18805726Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.
PubMed 16461174Botelho MB, Andrade BB. Effect of cervical spine manipulative therapy on judo athletes' grip strength. J Manipulative Physiol Ther. 2012 Jan;35(1):38-44. doi: 10.1016/j.jmpt.2011.09.005. Epub 2011 Nov 10.
PubMed 22079053Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
PubMed 19028251Dishman JD, Ball KA, Burke J. First Prize: Central motor excitability changes after spinal manipulation: a transcranial magnetic stimulation study. J Manipulative Physiol Ther. 2002 Jan;25(1):1-9.
PubMed 11898013Hegedus EJ, Goode A, Butler RJ, Slaven E. The neurophysiological effects of a single session of spinal joint mobilization: does the effect last? J Man Manip Ther. 2011 Aug;19(3):143-51. doi: 10.1179/2042618611Y.0000000003.
PubMed 22851877Lawrence MA, Raymond JT, Look AE, Woodard NM, Schicker CM, Swanson BT. Effects of Tibiofibular and Ankle Joint Manipulation on Hip Strength and Muscle Activation. J Manipulative Physiol Ther. 2020 Jun;43(5):406-417. doi: 10.1016/j.jmpt.2019.10.005. Epub 2020 Jul 20.
PubMed 32703611Michener LA, Kardouni JR, Lopes Albers AD, Ely JM. Development of a sham comparator for thoracic spinal manipulative therapy for use with shoulder disorders. Man Ther. 2013 Feb;18(1):60-4. doi: 10.1016/j.math.2012.07.003. Epub 2012 Aug 9.
PubMed 22883130Parkinson AO, Apps CL, Morris JG, Barnett CT, Lewis MGC. The Calculation, Thresholds and Reporting of Inter-Limb Strength Asymmetry: A Systematic Review. J Sports Sci Med. 2021 Oct 1;20(4):594-617. doi: 10.52082/jssm.2021.594. eCollection 2021 Dec.
PubMed 35321131
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High Velocity Low Amplitude Mid-Thoracic Spinal Segment Manipulation on the Force Output of the Hip Adductors and Extensors and the Latissimus Dorsi in Healthy Individuals With Unilateral Hip Adductor Weakness
- ClinicalTrials.gov ID
- NCT06534931
- Acronym / sponsor ID
- ThoracicManip
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Collaborators
- Raymond Chiropractic
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 2 Aug 2024 (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 goal of this trial was to determine if a mid-thoracic high velocity low amplitude spinal manipulation improves force output in those with unilateral hip adductor weakness. The main aims were to determine if the intervention:
Improved hip adductor force and muscle activation immediately and 48 h post manipulation compared to a control group.
Improved gluteus maximus and latissimus dorsi force and muscle activation immediately and 48 h post manipulation compared to a control group.
Strength and muscle activation of the hip adductors, hip extensors (gluteus maximus), and shoulder extensors (latissimus dorsi) were measured prior to, immediate after, and 48 hours after receiving a high velocity low amplitude manipulation to the thoracic spine. The manipulation was performed by a licensed chiropractor.
A control group received a validated sham manipulation to the thoracic spine. Participants were blinded to group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Procedure: High velocity low amplitude thoracic spine manipulationThose in the intervention group received a high velocity low amplitude manipulation to the mid-thoracic spine provided by a licensed chiropractor. |
| Sham | Sham comparator | Procedure: ShamThose in the control group received a validated sham manipulation to the mid-thoracic spine. The sham manipulation was done so that there was minimal downward force applied to the spine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral hip adductor weakness, as assessed by manual muscle testing
- Pain free hip motion
- No contraindications to high velocity thoracic spine manipulation including:
- Any known active cancer/ Metastatic Bone Cancer Osteoporosis or other metabolic bone disorders Signs of spinal cord compression Nerve root compression with increasing neurologic deficit Signs of Vertebrobasilar insufficiency/ cervical artery abnormalities Bleeding Diatheses Angina pectoris
Key exclusion criteria (6 listed)
- Current pain in the adductor muscle group
- Past history of hip surgery
- Past history of hip fracture
- History of spine or rib fractures
- Psoas muscle group (hip flexor) weakness as determined by manual muscle testing
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 |
|---|---|---|
| High velocity low amplitude thoracic spine manipulationParticipants were supine on a treatment table. The chiropractor determined levels of apparent spinal dysfunction by means of static palpation. Participants were then asked to curl forward and bring their knees to their chest as the chiropractor placed a fist just inferior to the targeted level, anywhere between the T4 - T10 vertebrae. The participant was instructed to inhale and then exhale, at which point the chiropractor lowered the participant's torso back to the table and delivered a thrust using his body into his fist. | Procedure or surgery | Manipulation |
| ShamA previously validated physiologically inert manual procedure to the thoracic spine | Procedure or surgery | Sham |
Primary outcome
Hip adductor force (weak limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
Isometric force produced by the hip adductors in the weaker limb. Measured with a force transducer and reported in Newtons.
Hip adductor muscle activity (weak limb)
Time frame: Pre intervention, immediatly post intervention
Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.
10 secondary outcomes
Hip extension force (strong limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
Gluteus maximus muscle activity (strong limb)
Time frame: Pre intervention, immediatly post intervention
Hip extension force (weak limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
Gluteus maximus muscle activity (weak limb)
Time frame: Pre intervention, immediatly post intervention
Shoulder extension force (weak limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
Latissimus dorsi muscle activity (weak limb)
Time frame: Pre intervention, immediatly post intervention
Shoulder extension force (strong limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
Latissimus dorsi muscle activity (strong limb)
Time frame: Pre intervention, immediatly post intervention
Hip adductor muscle activity (strong limb)
Time frame: Pre intervention, immediatly post intervention
Hip adductor force (strong limb)
Time frame: Pre intervention, immediatly post intervention, 48 hours post intervention
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 2 Aug 2024.
- Background: PubMed 34164712Haavik H, Kumari N, Holt K, Niazi IK, Amjad I, Pujari AN, Turker KS, Murphy B. The contemporary model of vertebral column joint dysfunction and impact of high-velocity, low-amplitude controlled vertebral thrusts on neuromuscular function. Eur J Appl Physiol. 2021 Oct;121(10):2675-2720. doi: 10.1007/s00421-021-04727-z. Epub 2021 Jun 23.
- Background: PubMed 29327170Christiansen TL, Niazi IK, Holt K, Nedergaard RW, Duehr J, Allen K, Marshall P, Turker KS, Hartvigsen J, Haavik H. The effects of a single session of spinal manipulation on strength and cortical drive in athletes. Eur J Appl Physiol. 2018 Apr;118(4):737-749. doi: 10.1007/s00421-018-3799-x. Epub 2018 Jan 11.
- Background: PubMed 30804399Holt K, Niazi IK, Nedergaard RW, Duehr J, Amjad I, Shafique M, Anwar MN, Ndetan H, Turker KS, Haavik H. The effects of a single session of chiropractic care on strength, cortical drive, and spinal excitability in stroke patients. Sci Rep. 2019 Feb 25;9(1):2673. doi: 10.1038/s41598-019-39577-5.
- Background: PubMed 33321904Niazi IK, Kamavuako EN, Holt K, Janjua TAM, Kumari N, Amjad I, Haavik H. The Effect of Spinal Manipulation on the Electrophysiological and Metabolic Properties of the Tibialis Anterior Muscle. Healthcare (Basel). 2020 Dec 10;8(4):548. doi: 10.3390/healthcare8040548.
- Background: PubMed 25579661Niazi IK, Turker KS, Flavel S, Kinget M, Duehr J, Haavik H. Changes in H-reflex and V-waves following spinal manipulation. Exp Brain Res. 2015 Apr;233(4):1165-73. doi: 10.1007/s00221-014-4193-5. Epub 2015 Jan 13.
- Background: PubMed 21886280Chilibeck PD, Cornish SM, Schulte A, Jantz N, Magnus CR, Schwanbeck S, Juurlink BH. The effect of spinal manipulation on imbalances in leg strength. J Can Chiropr Assoc. 2011 Sep;55(3):183-92.
- Background: PubMed 18805726Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.
- Background: PubMed 16461174Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.
- Background: PubMed 22079053Botelho MB, Andrade BB. Effect of cervical spine manipulative therapy on judo athletes' grip strength. J Manipulative Physiol Ther. 2012 Jan;35(1):38-44. doi: 10.1016/j.jmpt.2011.09.005. Epub 2011 Nov 10.
- Background: PubMed 19028251Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
- Background: PubMed 11898013Dishman JD, Ball KA, Burke J. First Prize: Central motor excitability changes after spinal manipulation: a transcranial magnetic stimulation study. J Manipulative Physiol Ther. 2002 Jan;25(1):1-9.
- Background: PubMed 22851877Hegedus EJ, Goode A, Butler RJ, Slaven E. The neurophysiological effects of a single session of spinal joint mobilization: does the effect last? J Man Manip Ther. 2011 Aug;19(3):143-51. doi: 10.1179/2042618611Y.0000000003.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High velocity low amplitude thoracic spine manipulation in people with Muscle Weakness, run by University of New England at 1 site in United States.
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 6 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 2 Aug 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Hip adductor force (weak limb) (time frame: Pre intervention, immediatly post intervention, 48 hours post intervention). The study lists 2 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 NCT06534931, 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 2 Aug 2024.