Degenerative Lumbar Spinal StenosisNCT05190289
Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Scoliosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Degenerative Scoliosis
- What is being tested?
- Pre-existing degenerative factors of paraspinal muscles and bone mass
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2021to 30 Sep 2022
- Phase
- Observational
- 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 45 years and older
- All sexes
- Adult, Older adult
Study population: In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative diseases, and were performed by posterior surgery will be enrolled.
Who may be able to join
- Underwent posterior surgery for degenerative scoliosis;
- Above the age of 45;
- Satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis > 5cm, pelvic tilt > 25°, or thoracic kyphosis > 60°.
Who cannot join
- Underwent posterior surgery for lumbar spinal stenosis;
- Above the age of 45;
- Diagnosis of lumbar spinal stenosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Gengyu Han, M.D., +86 15701206146, 475210693@qq.com
About this study
Official title: The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases
This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.
Read the detailed description
This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in our hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.
The investigators intended to review the patients who underwent posterior surgery for degenerative lumbar diseases from January 2010 to December 2019.
- To review the patients who underwent posterior surgery in orthopedic department for degenerative scoliosis. The inclusion criteria were: (1) above the age of 45; (2) satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis (SVA) > 5cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
- To review the patients who underwent posterior surgery in orthopedic department for lumbar spinal stenosis. The inclusion criteria were: (1) above the age of 45; (2) diagnosis of lumbar spinal stenosis. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
- Being tested
- Pre-existing degenerative factors of paraspinal muscles and bone mass
- Keywords
- Degenerative Lumbar Disease, Clinical Outcome, Complication, Paraspinal Muscle, Bone Mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-existing degenerative factors of paraspinal muscles and bone massOther
Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass
| Study group | Role | What they receive |
|---|---|---|
| Compared Group | Patients without inferior clinical outcomes Receives: Other: Pre-existing degenerative factors of paraspinal muscles and bone mass | |
| Case Group | Patients with inferior clinical outcomes Receives: Other: Pre-existing degenerative factors of paraspinal muscles and bone mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
The Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.
Measured: 12 months; through study completion, an average of 3 years
Low Back pain
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Measured: 12 months; through study completion, an average of 3 years
Leg pain
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Measured: 12 months; through study completion, an average of 3 years
Sagittal balance
Sagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.
Measured: 12 months; through study completion, an average of 3 years
Bone nonunion
Bone nonunion was evaluated by dynamic X-ray. Bone nonunion was defined as 1) there was no continued bone fusion mass at any fusion segment; 2) any motion (greater than 3 mm or 3°) on flexion/ extension plain radiographs.
Measured: 12 months; through study completion, an average of 3 years
Screw loosening
Screw loosening was evaluated on spine radiograph or CT. Screw loosening was defined when a 1mm or wider circumferential radiolucent line around the pedicle screw was confirmed.
Measured: 12 months; through study completion, an average of 3 years
Proximal junctional kyphosis
Proximal junctional angle (PJA) was determined by the sagittal angle subtended by the inferior endplate of the uppermost instrumented vertebra (UIV) and the superior end plate of the vertebrae two levels above the UIV (UIV + 2). The definition of proximal junctional kyphosis (PJK) was PJA 10 or greater and at least 10 greater than the corresponding preoperative measurement.
Measured: 12 months; through study completion, an average of 3 years
Proximal scoliosis progression
The proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.
Measured: 12 months; through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start3 Apr 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Shi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190289
- Sponsor's protocol ID
- M2021134
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the clinical study report available for half a year after the publication of the results of the study.
Publications
Ropponen A, Videman T, Battie MC. The reliability of paraspinal muscles composition measurements using routine spine MRI and their association with back function. Man Ther. 2008 Aug;13(4):349-56. doi: 10.1016/j.math.2007.03.004. Epub 2007 Jun 6.
PubMed 17556006Anderson DE, Bean JF, Holt NE, Keel JC, Bouxsein ML. Computed tomography-based muscle attenuation and electrical impedance myography as indicators of trunk muscle strength independent of muscle size in older adults. Am J Phys Med Rehabil. 2014 Jul;93(7):553-61. doi: 10.1097/PHM.0000000000000059.
PubMed 24508931Cooley JR, Walker BF, M Ardakani E, Kjaer P, Jensen TS, Hebert JJ. Relationships between paraspinal muscle morphology and neurocompressive conditions of the lumbar spine: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2018 Sep 27;19(1):351. doi: 10.1186/s12891-018-2266-5.
PubMed 30261870Crawford RJ, Cornwall J, Abbott R, Elliott JM. Manually defining regions of interest when quantifying paravertebral muscles fatty infiltration from axial magnetic resonance imaging: a proposed method for the lumbar spine with anatomical cross-reference. BMC Musculoskelet Disord. 2017 Jan 19;18(1):25. doi: 10.1186/s12891-016-1378-z.
PubMed 28103921Hong X, Shi R, Wang YT, Liu L, Bao JP, Wu XT. Lumbar disc herniation treated by microendoscopic discectomy : Prognostic predictors of long-term postoperative outcome. Orthopade. 2018 Dec;47(12):993-1002. doi: 10.1007/s00132-018-3624-6.
PubMed 30171289Zotti MGT, Boas FV, Clifton T, Piche M, Yoon WW, Freeman BJC. Does pre-operative magnetic resonance imaging of the lumbar multifidus muscle predict clinical outcomes following lumbar spinal decompression for symptomatic spinal stenosis? Eur Spine J. 2017 Oct;26(10):2589-2597. doi: 10.1007/s00586-017-4986-x. Epub 2017 Feb 8.
PubMed 28180981Storheim K, Berg L, Hellum C, Gjertsen O, Neckelmann G, Espeland A, Keller A; Norwegian Spine Study Group. Fat in the lumbar multifidus muscles - predictive value and change following disc prosthesis surgery and multidisciplinary rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up of a randomized trial. BMC Musculoskelet Disord. 2017 Apr 4;18(1):145. doi: 10.1186/s12891-017-1505-5.
PubMed 28376754Pennington Z, Cottrill E, Ahmed AK, Passias P, Protopsaltis T, Neuman B, Kebaish KM, Ehresman J, Westbroek EM, Goodwin ML, Sciubba DM. Paraspinal muscle size as an independent risk factor for proximal junctional kyphosis in patients undergoing thoracolumbar fusion. J Neurosurg Spine. 2019 May 31;31(3):380-388. doi: 10.3171/2019.3.SPINE19108. Print 2019 Sep 1.
PubMed 31151107Betz M, Burgstaller JM, Held U, Andreisek G, Steurer J, Porchet F, Farshad M; LSOS Study Group. Influence of Paravertebral Muscle Quality on Treatment Efficacy of Epidural Steroid Infiltration or Surgical Decompression in Lumbar Spinal Stenosis-Analysis of the Lumbar Spinal Outcome Study (LSOS) Data: A Swiss Prospective Multicenter Cohort Study. Spine (Phila Pa 1976). 2017 Dec 1;42(23):1792-1798. doi: 10.1097/BRS.0000000000002233.
PubMed 28542102
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases
- ClinicalTrials.gov ID
- NCT05190289
- Acronym / sponsor ID
- M2021134
- Keywords
- Degenerative Lumbar Disease, Clinical Outcome, Complication, Paraspinal Muscle, Bone Mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Jan 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.
This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.
Detailed description
This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in our hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.
The investigators intended to review the patients who underwent posterior surgery for degenerative lumbar diseases from January 2010 to December 2019.
- To review the patients who underwent posterior surgery in orthopedic department for degenerative scoliosis. The inclusion criteria were: (1) above the age of 45; (2) satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis (SVA) > 5cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
- To review the patients who underwent posterior surgery in orthopedic department for lumbar spinal stenosis. The inclusion criteria were: (1) above the age of 45; (2) diagnosis of lumbar spinal stenosis. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compared Group | – | Other: Pre-existing degenerative factors of paraspinal muscles and bone massPatients without inferior clinical outcomes |
| Case Group | – | Other: Pre-existing degenerative factors of paraspinal muscles and bone massPatients with inferior clinical outcomes |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative diseases, and were performed by posterior surgery will be enrolled.
Key inclusion criteria (3 listed)
- Underwent posterior surgery for degenerative scoliosis;
- Above the age of 45;
- Satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis > 5cm, pelvic tilt > 25°, or thoracic kyphosis > 60°.
Key exclusion criteria (3 listed)
- Underwent posterior surgery for lumbar spinal stenosis;
- Above the age of 45;
- Diagnosis of lumbar spinal stenosis.
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 |
|---|---|---|
| Pre-existing degenerative factors of paraspinal muscles and bone massPre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass | Other | Case Group, Compared Group |
Primary outcome
Disability
Time frame: 12 months; through study completion, an average of 3 years
The Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.
Low Back pain
Time frame: 12 months; through study completion, an average of 3 years
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Leg pain
Time frame: 12 months; through study completion, an average of 3 years
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Sagittal balance
Time frame: 12 months; through study completion, an average of 3 years
Sagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.
Bone nonunion
Time frame: 12 months; through study completion, an average of 3 years
Bone nonunion was evaluated by dynamic X-ray. Bone nonunion was defined as 1) there was no continued bone fusion mass at any fusion segment; 2) any motion (greater than 3 mm or 3°) on flexion/ extension plain radiographs.
Screw loosening
Time frame: 12 months; through study completion, an average of 3 years
Screw loosening was evaluated on spine radiograph or CT. Screw loosening was defined when a 1mm or wider circumferential radiolucent line around the pedicle screw was confirmed.
Proximal junctional kyphosis
Time frame: 12 months; through study completion, an average of 3 years
Proximal junctional angle (PJA) was determined by the sagittal angle subtended by the inferior endplate of the uppermost instrumented vertebra (UIV) and the superior end plate of the vertebrae two levels above the UIV (UIV + 2). The definition of proximal junctional kyphosis (PJK) was PJA 10 or greater and at least 10 greater than the corresponding preoperative measurement.
Proximal scoliosis progression
Time frame: 12 months; through study completion, an average of 3 years
The proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Results publication: PubMed 17556006Ropponen A, Videman T, Battie MC. The reliability of paraspinal muscles composition measurements using routine spine MRI and their association with back function. Man Ther. 2008 Aug;13(4):349-56. doi: 10.1016/j.math.2007.03.004. Epub 2007 Jun 6.
- Results publication: PubMed 24508931Anderson DE, Bean JF, Holt NE, Keel JC, Bouxsein ML. Computed tomography-based muscle attenuation and electrical impedance myography as indicators of trunk muscle strength independent of muscle size in older adults. Am J Phys Med Rehabil. 2014 Jul;93(7):553-61. doi: 10.1097/PHM.0000000000000059.
- Results publication: PubMed 30261870Cooley JR, Walker BF, M Ardakani E, Kjaer P, Jensen TS, Hebert JJ. Relationships between paraspinal muscle morphology and neurocompressive conditions of the lumbar spine: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2018 Sep 27;19(1):351. doi: 10.1186/s12891-018-2266-5.
- Results publication: PubMed 28103921Crawford RJ, Cornwall J, Abbott R, Elliott JM. Manually defining regions of interest when quantifying paravertebral muscles fatty infiltration from axial magnetic resonance imaging: a proposed method for the lumbar spine with anatomical cross-reference. BMC Musculoskelet Disord. 2017 Jan 19;18(1):25. doi: 10.1186/s12891-016-1378-z.
- Results publication: PubMed 30171289Hong X, Shi R, Wang YT, Liu L, Bao JP, Wu XT. Lumbar disc herniation treated by microendoscopic discectomy : Prognostic predictors of long-term postoperative outcome. Orthopade. 2018 Dec;47(12):993-1002. doi: 10.1007/s00132-018-3624-6.
- Results publication: PubMed 28180981Zotti MGT, Boas FV, Clifton T, Piche M, Yoon WW, Freeman BJC. Does pre-operative magnetic resonance imaging of the lumbar multifidus muscle predict clinical outcomes following lumbar spinal decompression for symptomatic spinal stenosis? Eur Spine J. 2017 Oct;26(10):2589-2597. doi: 10.1007/s00586-017-4986-x. Epub 2017 Feb 8.
- Results publication: PubMed 28376754Storheim K, Berg L, Hellum C, Gjertsen O, Neckelmann G, Espeland A, Keller A; Norwegian Spine Study Group. Fat in the lumbar multifidus muscles - predictive value and change following disc prosthesis surgery and multidisciplinary rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up of a randomized trial. BMC Musculoskelet Disord. 2017 Apr 4;18(1):145. doi: 10.1186/s12891-017-1505-5.
- Results publication: PubMed 31151107Pennington Z, Cottrill E, Ahmed AK, Passias P, Protopsaltis T, Neuman B, Kebaish KM, Ehresman J, Westbroek EM, Goodwin ML, Sciubba DM. Paraspinal muscle size as an independent risk factor for proximal junctional kyphosis in patients undergoing thoracolumbar fusion. J Neurosurg Spine. 2019 May 31;31(3):380-388. doi: 10.3171/2019.3.SPINE19108. Print 2019 Sep 1.
- Results publication: PubMed 28542102Betz M, Burgstaller JM, Held U, Andreisek G, Steurer J, Porchet F, Farshad M; LSOS Study Group. Influence of Paravertebral Muscle Quality on Treatment Efficacy of Epidural Steroid Infiltration or Surgical Decompression in Lumbar Spinal Stenosis-Analysis of the Lumbar Spinal Outcome Study (LSOS) Data: A Swiss Prospective Multicenter Cohort Study. Spine (Phila Pa 1976). 2017 Dec 1;42(23):1792-1798. doi: 10.1097/BRS.0000000000002233.
- Individual participant dataSharing planned: Yes. We will make the clinical study report available for half a year after the publication of the results of the study.
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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.
Wei-Shi Li, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Scoliosis, run by Peking University Third Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gengyu Han, M.D. (+86 15701206146, 475210693@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: 12 months; through study completion, an average of 3 years). The study lists 8 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 NCT05190289, which also lists 9 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 13 Jan 2022.