Parkinson DiseaseNCT04946760
Effects of OMT on Gait Kinematics and Postural Control in Parkinson Disease
A study of Parkinson Disease, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
Parkinson Disease is a degenerative process that affects millions each year, and has devastating effects on patients and their families. The mobility symptoms that manifest as the disease progresses can result in social isolation as patients may be embarrassed or fear falling in public. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 16 Sep 2019
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For PD participants: Neurologist-diagnosed idiopathic PD, H\&Y stages 1.0-3.0
- Ability to stand independently for 1 minute and ambulate 100 yards independently
- Healthy (not under ongoing medical care for health problems that could impact performance on study tasks)
- for controls: age-matched healthy adults
Who cannot join
- Idiopathic PD in Hoehn \& Yahr stages >3.0
- Previous surgical management of PD (pallidotomy, deep brain stimulation
- Central or peripheral nervous system disorders other than PD including, but not limited to multiple sclerosis, cerebral palsy, Alzheimer's diseases, or chronic fatigue syndrome
- Cognitive impairment as defined by the Mini-Mental Status Examination (<26 for subjects with PD and <24 for control subjects)
- Unable to stand independently for 1 minute and to walk independently for 100 yards
- Body weight >400lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Parkinson Disease is a degenerative process that affects millions each year, and has devastating effects on patients and their families. The mobility symptoms that manifest as the disease progresses can result in social isolation as patients may be embarrassed or fear falling in public. One of the common risks resulting from the PD is falls. Falling in PD is primarily related to musculoskeletal issues such as muscular rigidity, postural instability \& stooped posture. These kinds of manifestations should be amenable to treatment with OMT. There are studies showing the positive impact that OMT has on gait in PD, and a study showing improvement in balance in non-PD subjects. This investigation is designed to address these components via the following specific aims:
- Identify the effects of a Neck-down OMT (OMT-ND) protocol on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved joint flexibility, improved proprioception and decreased muscle co-activation.
- Determine the efficacy of Whole-body OMT (OMT-WB) protocol including cranial manipulation on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the addition of a cranial manipulation protocol will further improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved arterial blood flow to the brain, which results from improving the cranial bone motion, maximizing venous drainage, and reducing any restrictions around the vestibular system.
Read the detailed description
Disordered health does not simply progress in one direction from disease process, to disability, to handicap; rather, the process is a complex interaction between health conditions, body structure and function, environmental and personal factors, and limitations in activity and participation. Biologic,behavioral, environmental, and socioeconomic risk factors can all contribute to this progression. In the case of Parkinson disease (PD), this progression includes the degradation of balance and stability resulting in falls. Parkinson disease (PD) is the second most common neurodegenerative disease worldwide. It results from a lack of dopamine production within the substantia nigra, and is characterized by slowness of movement (bradykinesia), muscle rigidity (akinesia), postural instability, and resting tremor. As a result, PD patients have a characteristic short shuffling gait, with a loss of associated arm motion. Gait initiation is difficult and sudden freezing may impair components of movement such as turning. Postural instability and gait difficulty increase over the course of the disease, and expose PD patients to a nine times greater risk of falls. Falls can cause physical injuries such as fractures and/or head injuries leading to functional incapacity, increased risk of nursing home admission and higher mortality rate. Musculoskeletal manifestations of PD may be as impactful as the nervous system manifestations. For example, muscle rigidity associated with dopaminergic loss can lead to somatic dysfunction, which can impact posture and gait. Osteopathic medicine, with its philosophical understanding of the central role of the musculoskeletal system, is in an ideal model for this direction of research. Recent evidence has demonstrated OMT's efficacy in improving postural control in healthy older subjects. Wells et al., were the first to examine the effects of an OMT protocol in a cohort of persons with PD. While this study demonstrated a positive effect on gait kinematics, it investigation failed to examine static components of postural control, which are the most common cause of falls in PD.
The investigators have carefully designed this study to identify the effects that an OMT protocol has on gait kinematics and postural control in subjects with PD. This design compares the effectiveness of two OMT protocols: the Neck-Down (OMT-ND) protocol focuses on addressing biomechanical dysfunctions from the neck down; and the Whole-Body (OMT-WB) protocol, includes the ND techniques and adds specific Osteopathic Cranial Manipulative Medicine (OCMM) techniques to address dysfunctions in the head.
The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge due to improved joint flexibility, improved proprioception and decreased muscle coactivation. The investigators hypothesize that the addition of a cranial manipulation protocol will further improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved arterial blood flow to the brain, which results from improving the cranial bone motion, maximizing venous drainage, and reducing any restrictions around the vestibular system.
The investigators also include a sham group to strengthen the internal validity of the OMT- ND and OMT-WB protocols. Research on OMT's specific effects is sometimes difficult to differentiate from placebo effects. Distinct placebo components include assessment and observation, therapeutic ritual, and a supportive patient-practitioner relationship. The sham treatment will control for these components with minimal impact on the biomechanical dysfunctions in our subjects.
The investigators plan to investigate the effect of these OMT protocols via the following specific aims:
- Identify the effects of a Neck-down OMT protocol (OMT-ND) on gait kinematics and postural control in Parkinson disease;
- Determine the efficacy of a Whole-body OMT protocol (OMT-WB) including cranial manipulation on gait kinematics and postural control in Parkinson disease.
The investigators' long-term goal is create a reproducible protocol that improves gait and postural control, and helps to reduce falls and improve quality of life in persons with PD. If the results validate the previous studies and prove the hypotheses, this study will advance osteopathic medicine by demonstrating OMT as a useful adjunct treatment in patients with PD. The investigators' expectation is that by improving gait and postural control, OMT can help PD patients reduce falls, which may allow them to be more active and lead a better quality of life.
- Conditions
- Parkinson Disease
- Being tested
- Sham Manipulation
- Keywords
- Osteopathic Manipulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham ManipulationOther
The sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Sham Protocol | Sham comparator | The sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention. To provide a sham for the OMT-WB protocol, subjects will lie supine with the physician's hands under the occiput, palms toward the table, so that the subject's head rests on the dorsal aspect of the physician's hands. The time used in the sham procedures will be approximately 20-25 minutes. Receives: Other: Sham Manipulation |
| Whole-Body Protocol | Experimental | The whole-body protocol will include all the techniques in the OMT-ND protocol, but will also include techniques focused on the expected cranial dysfunctions [Rivera-Martinez 2002]. The OMT-WB protocol will last approximately 25-30 minutes.
The techniques will include:
* Evaluation for strain pattern(s)
* Occipitolatlantal decompression
* Sphenobasilar synchondrosis decompression
* Occipitomastoid suture V-spread
* Temporal bone balancing
* Venous sinus drainage technique Receives: Other: Sham Manipulation |
| Neck-down protocol | Experimental | The neck-down protocol takes into consideration previous relevant studies [Lopez 2011, Wells 1999]. OMT will be used bilaterally on the following areas with one or more techniques, including myofascial release, articulatory, muscle energy, and balanced ligamentous tension. The OMT-ND protocol will last approximately 15-20 minutes.
* Cervical spine
* Thoracic spine
* Lumbar spine
* Shoulder girdle
* Sacroiliac joint
* Innominates
* Leg muscles (including psoas, piriformis, hamstring, adductors)
* Ankles Receives: Other: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and Go test
The "Timed Up and Go" Test (TUG), which measures the ability of participants to perform sequential mobility tasks that incorporate walking and turning. Specifically, in this timed test, participants begin in a seated position in an armchair. They are asked to rise, go forward 3m, turn around and sit back down. In older adults at risk for falls and persons with PD, the TUG has been found to possess excellent intra-tester reliability (0.94-0.96) and predictive validity, with increased times on the TUG relating to higher fall-risk.
Measured: Pre and immediately post intervention, change will be reported
Functional Reach Test
The functional reach test (FR) is a simple balance task that tests the ability of a person to move their center of mass to the anterior limits of their base of support by measuring the distance a participant can reach forward from a quiet stance position. [Duncan, 1990; Duncan, 1992] The FR distance has previously been demonstrated to be predictive of fall risk in elderly persons, possess excellent test-retest reliability,[Brusse, 2005; Steffen, 2005] and can distinguish between those persons with PD with a history of falls from those with no falling history.
Measured: Pre and immediately post intervention, change will be reported
Secondary outcomes (2)
Gait kinematics
Kinetic, kinematic, and spatiotemporal measures will be gathered during gait using the predetermined comfortable walking speed. This will include joint angles, center of mass, center of pressure, stride length and stride width.
Measured: Pre and immediately post intervention, change will be reported
Postural control
The postural control task in this investigation will also be assessed using the CAREN system by inducing perturbations on a dual-belt treadmill. Unexpected perturbations will be delivered in the forward and backward direction during static stance and straight-line ambulation by manipulating the speed and acceleration of the treadmill. Five perturbations will be delivered per direction (forward/backward), for a total of 10 perturbations per participant. Measure of body sway and time to stability will be collected.
Outcome measures will be assessed using a 12-camera Motion Analysis system (Cortex Motion Analysis, Santa Rosa, CA).
Measured: Pre and immediately post intervention, change will be reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Sep 2016
- Primary completion15 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, Kendi Hensel, DO, PhD, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946760
- Sponsor's protocol ID
- #2016-097
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of OMT on Gait Kinematics and Postural Control in Parkinson Disease
- ClinicalTrials.gov ID
- NCT04946760
- Acronym / sponsor ID
- #2016-097
- Conditions
- Parkinson Disease
- Keywords
- Osteopathic Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 1 Jul 2021 (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.
Parkinson Disease is a degenerative process that affects millions each year, and has devastating effects on patients and their families. The mobility symptoms that manifest as the disease progresses can result in social isolation as patients may be embarrassed or fear falling in public. One of the common risks resulting from the PD is falls. Falling in PD is primarily related to musculoskeletal issues such as muscular rigidity, postural instability \& stooped posture. These kinds of manifestations should be amenable to treatment with OMT. There are studies showing the positive impact that OMT has on gait in PD, and a study showing improvement in balance in non-PD subjects. This investigation is designed to address these components via the following specific aims:
- Identify the effects of a Neck-down OMT (OMT-ND) protocol on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved joint flexibility, improved proprioception and decreased muscle co-activation.
- Determine the efficacy of Whole-body OMT (OMT-WB) protocol including cranial manipulation on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the addition of a cranial manipulation protocol will further improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved arterial blood flow to the brain, which results from improving the cranial bone motion, maximizing venous drainage, and reducing any restrictions around the vestibular system.
Detailed description
Disordered health does not simply progress in one direction from disease process, to disability, to handicap; rather, the process is a complex interaction between health conditions, body structure and function, environmental and personal factors, and limitations in activity and participation. Biologic,behavioral, environmental, and socioeconomic risk factors can all contribute to this progression. In the case of Parkinson disease (PD), this progression includes the degradation of balance and stability resulting in falls. Parkinson disease (PD) is the second most common neurodegenerative disease worldwide. It results from a lack of dopamine production within the substantia nigra, and is characterized by slowness of movement (bradykinesia), muscle rigidity (akinesia), postural instability, and resting tremor. As a result, PD patients have a characteristic short shuffling gait, with a loss of associated arm motion. Gait initiation is difficult and sudden freezing may impair components of movement such as turning. Postural instability and gait difficulty increase over the course of the disease, and expose PD patients to a nine times greater risk of falls. Falls can cause physical injuries such as fractures and/or head injuries leading to functional incapacity, increased risk of nursing home admission and higher mortality rate. Musculoskeletal manifestations of PD may be as impactful as the nervous system manifestations. For example, muscle rigidity associated with dopaminergic loss can lead to somatic dysfunction, which can impact posture and gait. Osteopathic medicine, with its philosophical understanding of the central role of the musculoskeletal system, is in an ideal model for this direction of research. Recent evidence has demonstrated OMT's efficacy in improving postural control in healthy older subjects. Wells et al., were the first to examine the effects of an OMT protocol in a cohort of persons with PD. While this study demonstrated a positive effect on gait kinematics, it investigation failed to examine static components of postural control, which are the most common cause of falls in PD.
The investigators have carefully designed this study to identify the effects that an OMT protocol has on gait kinematics and postural control in subjects with PD. This design compares the effectiveness of two OMT protocols: the Neck-Down (OMT-ND) protocol focuses on addressing biomechanical dysfunctions from the neck down; and the Whole-Body (OMT-WB) protocol, includes the ND techniques and adds specific Osteopathic Cranial Manipulative Medicine (OCMM) techniques to address dysfunctions in the head.
The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge due to improved joint flexibility, improved proprioception and decreased muscle coactivation. The investigators hypothesize that the addition of a cranial manipulation protocol will further improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved arterial blood flow to the brain, which results from improving the cranial bone motion, maximizing venous drainage, and reducing any restrictions around the vestibular system.
The investigators also include a sham group to strengthen the internal validity of the OMT- ND and OMT-WB protocols. Research on OMT's specific effects is sometimes difficult to differentiate from placebo effects. Distinct placebo components include assessment and observation, therapeutic ritual, and a supportive patient-practitioner relationship. The sham treatment will control for these components with minimal impact on the biomechanical dysfunctions in our subjects.
The investigators plan to investigate the effect of these OMT protocols via the following specific aims:
- Identify the effects of a Neck-down OMT protocol (OMT-ND) on gait kinematics and postural control in Parkinson disease;
- Determine the efficacy of a Whole-body OMT protocol (OMT-WB) including cranial manipulation on gait kinematics and postural control in Parkinson disease.
The investigators' long-term goal is create a reproducible protocol that improves gait and postural control, and helps to reduce falls and improve quality of life in persons with PD. If the results validate the previous studies and prove the hypotheses, this study will advance osteopathic medicine by demonstrating OMT as a useful adjunct treatment in patients with PD. The investigators' expectation is that by improving gait and postural control, OMT can help PD patients reduce falls, which may allow them to be more active and lead a better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Protocol | Sham comparator | Other: Sham ManipulationThe sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention. To provide a sham for the OMT-WB protocol, subjects will lie supine with the physician's hands under the occiput, palms toward the table, so that the subject's head rests on the dorsal aspect of the physician's hands. The time used in the sham procedures will be approximately 20-25 minutes. |
| Whole-Body Protocol | Experimental | Other: Sham ManipulationThe whole-body protocol will include all the techniques in the OMT-ND protocol, but will also include techniques focused on the expected cranial dysfunctions [Rivera-Martinez 2002]. The OMT-WB protocol will last approximately 25-30 minutes. The techniques will include: * Evaluation for strain pattern(s) * Occipitolatlantal decompression * Sphenobasilar synchondrosis decompression * Occipitomastoid suture V-spread * Temporal bone balancing * Venous sinus drainage technique |
| Neck-down protocol | Experimental | Other: Sham ManipulationThe neck-down protocol takes into consideration previous relevant studies [Lopez 2011, Wells 1999]. OMT will be used bilaterally on the following areas with one or more techniques, including myofascial release, articulatory, muscle energy, and balanced ligamentous tension. The OMT-ND protocol will last approximately 15-20 minutes. * Cervical spine * Thoracic spine * Lumbar spine * Shoulder girdle * Sacroiliac joint * Innominates * Leg muscles (including psoas, piriformis, hamstring, adductors) * Ankles |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For PD participants: Neurologist-diagnosed idiopathic PD, H\&Y stages 1.0-3.0
- Ability to stand independently for 1 minute and ambulate 100 yards independently
- Healthy (not under ongoing medical care for health problems that could impact performance on study tasks)
- for controls: age-matched healthy adults
Key exclusion criteria (6 listed)
- Idiopathic PD in Hoehn \& Yahr stages >3.0
- Previous surgical management of PD (pallidotomy, deep brain stimulation
- Central or peripheral nervous system disorders other than PD including, but not limited to multiple sclerosis, cerebral palsy, Alzheimer's diseases, or chronic fatigue syndrome
- Cognitive impairment as defined by the Mini-Mental Status Examination (<26 for subjects with PD and <24 for control subjects)
- Unable to stand independently for 1 minute and to walk independently for 100 yards
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 |
|---|---|---|
| Sham ManipulationThe sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention. | Other | Neck-down protocol, Sham Protocol, Whole-Body Protocol |
Primary outcome
Timed up and Go test
Time frame: Pre and immediately post intervention, change will be reported
The "Timed Up and Go" Test (TUG), which measures the ability of participants to perform sequential mobility tasks that incorporate walking and turning. Specifically, in this timed test, participants begin in a seated position in an armchair. They are asked to rise, go forward 3m, turn around and sit back down. In older adults at risk for falls and persons with PD, the TUG has been found to possess excellent intra-tester reliability (0.94-0.96) and predictive validity, with increased times on the TUG relating to higher fall-risk.
Functional Reach Test
Time frame: Pre and immediately post intervention, change will be reported
The functional reach test (FR) is a simple balance task that tests the ability of a person to move their center of mass to the anterior limits of their base of support by measuring the distance a participant can reach forward from a quiet stance position. [Duncan, 1990; Duncan, 1992] The FR distance has previously been demonstrated to be predictive of fall risk in elderly persons, possess excellent test-retest reliability,[Brusse, 2005; Steffen, 2005] and can distinguish between those persons with PD with a history of falls from those with no falling history.
2 secondary outcomes
Gait kinematics
Time frame: Pre and immediately post intervention, change will be reported
Postural control
Time frame: Pre and immediately post intervention, change will be reported
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 1 Jul 2021.
- 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.
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 of Parkinson Disease, run by University of North Texas Health Science Center 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 1 Jul 2021. 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?
Timed up and Go test (time frame: Pre and immediately post intervention, change will be reported). 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?
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 1 Jul 2021.