Chronic Non-Specific Low Back PainPRE-CBPNCT06915896
Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy.
An observational study of Chronic Non-Specific Low Back Pain and Chronic Non-specific Neck Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The aim of this study is to investigate the predictive value of various biopsychosocial variables on the outcomes of subjects with chronic spinal pain undergoing public health rehabilitation pathways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-Specific Low Back Pain, Chronic Non-specific Neck Pain
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2023to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.
Who may be able to join
- Age of majority;
- Medical diagnosis of nonspecific low back pain or nonspecific neck pain;
- Chronic symptoms, present for at least 6 months;
- Waiting for rehabilitation in a public health pathways
- Signature of informed consent to participate in the study and processing of personal data.
Who cannot join
- Subjects with cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi, Firenze
Florence, FI, 50124
Francesca Cecchi, +39 05573931, fcecchi@dongnocchi.it
About this study
Official title: Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy: Multicenter Prospective Study
The aim of this study is to investigate the predictive value of various biopsychosocial variables on the outcomes of subjects with chronic spinal pain undergoing public health rehabilitation pathways. Secondly, the study aims to assess the reliability of certain questionnaires, classified as Patient-Reported Outcome Measures (PROMs), which are frequently used in the evaluation of spinal pain but whose metric properties have not yet been established. These objectives will be pursued through two comprehensive assessment sessions (before and after rehabilitation), a re-test session immediately before rehabilitation (to evaluate the reliability of the questionnaires in stable subjects), and two follow-up assessments at 3 and 6 months after discharge.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic spinal pain patients attending public health rehabilitation pathways | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities.
For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity.
In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain.
(only on neck pain patients)
Measured: Second sessions (T1), after 3 month from enrollment
Roland and Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes.
For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24.
(only on low back pain patients)
Measured: Third session (T2), after 6 months from enrollment
Neck Disability Index
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities.
For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity.
In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain.
(only on neck pain patients)
Measured: Third session (T2), after 6 months from enrollment
Roland and Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes.
For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24.
(only on low back pain patients)
Measured: Second sessions (T1), after 3 month from enrollment
Neck Disability Index
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities.
For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity.
In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain.
(only on neck pain patients)
Measured: T0, at the enrollment
Roland and Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes.
For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24.
(only on low back pain patients)
Measured: T0, at the enrollment
TAMPA SCALE of KINESIOPHOBIA
test-retest relative reliability (intraclass correlation coefficient) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients).
It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders
Measured: re-test at baseline
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
test-retest relative reliability (intraclass correlation coefficient) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients).
It is a self-report questionnaire to measure attention to pain
Measured: re-test at baseline
PITTSBURGH SLEEP QUALITY INDEX
test-retest relative reliability (intraclass correlation coefficient) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.
Measured: re-test at baseline
TAMPA SCALE of KINESIOPHOBIA
test-retest absolute reliability (minimal detectable change (mdc) 95) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients).
It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders.
Measured: re-test at baseline
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
test-retest absolute reliability (minimal detectable change (mdc) 95) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients).
It is a self-report questionnaire to measure attention to pain
Measured: re-test at baseline
PITTSBURGH SLEEP QUALITY INDEX
test-retest absolute reliability (minimal detectable change (mdc) 95) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.
Measured: re-test at baseline
Secondary outcomes (18)
Pain Intensity
Numeric Pain Raiting scale 0-10
Measured: T0, at the enrollment
Pain Intensity
Numeric Pain Raiting scale 0-10
Measured: Second sessions (T1), after 3 month from enrollment
Pain Intensity
Numeric Pain Raiting scale 0-10
Measured: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Measured: T0, at the enrollment
Self-reported change
Global rating of Change Scale
Measured: Third session (T2), after 6 months from enrollment
Self-reported change
Global rating of Change Scale
Measured: Second sessions (T1), after 3 month from enrollment
Self-reported change
Global rating of Change Scale
Measured: T0, at the enrollment
Medication Use
yes/no
Measured: Third session (T2), after 6 months from enrollment
Medication Use
yes/no
Measured: Second sessions (T1), after 3 month from enrollment
Medication Use
yes/no
Measured: T0, at the enrollment
Pain Frequency
0-7 in a week
Measured: Third session (T2), after 6 months from enrollment
Pain Frequency
0-7 in a week
Measured: Second sessions (T1), after 3 month from enrollment
Pain Frequency
0-7 in a week
Measured: T0, at the enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Measured: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Short-Form 12 (SF12)
Measured: Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain.
(only for patients with cervicalgia)
Measured: T0, at the enrollment
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain.
(only for patients with cervicalgia)
Measured: Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a measurement scale based on a 13-item self-completion questionnaire designed to assess catastrophizing pain-related thoughts in adults with or without chronic pain.
(only for patients with cervicalgia)
Measured: Third session (T2), after 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Oct 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cecchi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915896
- Sponsor's protocol ID
- PRE-CBP
- Acronym
- PRE-CBP
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Variables of Outcome in Subjects With Chronic Rachialgia Referred to Different Pathways of Physiotherapy: Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06915896
- Acronym / sponsor ID
- PRE-CBP / PRE-CBP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Apr 2025 (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 investigate the predictive value of various biopsychosocial variables on the outcomes of subjects with chronic spinal pain undergoing public health rehabilitation pathways. Secondly, the study aims to assess the reliability of certain questionnaires, classified as Patient-Reported Outcome Measures (PROMs), which are frequently used in the evaluation of spinal pain but whose metric properties have not yet been established. These objectives will be pursued through two comprehensive assessment sessions (before and after rehabilitation), a re-test session immediately before rehabilitation (to evaluate the reliability of the questionnaires in stable subjects), and two follow-up assessments at 3 and 6 months after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic spinal pain patients attending public health rehabilitation pathways | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nonspecific spinal pain waiting for rehabilitation in public health pathways.
Key inclusion criteria (5 listed)
- Age of majority;
- Medical diagnosis of nonspecific low back pain or nonspecific neck pain;
- Chronic symptoms, present for at least 6 months;
- Waiting for rehabilitation in a public health pathways
- Signature of informed consent to participate in the study and processing of personal data.
Key exclusion criteria (1 listed)
- Subjects with cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neck Disability Index
Time frame: Second sessions (T1), after 3 month from enrollment
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)
Roland and Morris Disability Questionnaire
Time frame: Third session (T2), after 6 months from enrollment
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)
Neck Disability Index
Time frame: Third session (T2), after 6 months from enrollment
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)
Roland and Morris Disability Questionnaire
Time frame: Second sessions (T1), after 3 month from enrollment
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)
Neck Disability Index
Time frame: T0, at the enrollment
The Neck Disability Index (NDI) is a questionnaire that helps assess how neck pain affects a person's daily life. It consists of 10 sections, each exploring a specific aspect, such as the intensity of pain, the ability to dress and bathe, lift weights, read, concentrate, work, drive, sleep, and engage in leisure activities. For each section, the patient must choose one answer from six options, with a score ranging from 0 to 5. The lowest score indicates no difficulty, while the highest indicates pain so severe that it makes it impossible to perform the activity. In the end, by adding up the scores from all sections, a maximum score of 50 points is obtained. The higher the score, the greater the disability related to neck pain. (only on neck pain patients)
Roland and Morris Disability Questionnaire
Time frame: T0, at the enrollment
The Roland Morris Disability Questionnaire is used to assess low back pain. It consists of 24 questions directed at the patient regarding their ability or limitation in performing the 24 activities listed, which are typically difficult for a patient with low back pain to carry out. Additionally, the phrase "Due to the back..." has been added to the questions to distinguish limitations caused by lower back pain from those caused by other factors. The administration time is about 5 minutes. For each activity, the patient must give a score of 0 if the activity is not limited, or 1 if they have difficulty due to back pain. The total score ranges from 0 to 24. (only on low back pain patients)
TAMPA SCALE of KINESIOPHOBIA
Time frame: re-test at baseline
test-retest relative reliability (intraclass correlation coefficient) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients). It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
Time frame: re-test at baseline
test-retest relative reliability (intraclass correlation coefficient) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients). It is a self-report questionnaire to measure attention to pain
PITTSBURGH SLEEP QUALITY INDEX
Time frame: re-test at baseline
test-retest relative reliability (intraclass correlation coefficient) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.
TAMPA SCALE of KINESIOPHOBIA
Time frame: re-test at baseline
test-retest absolute reliability (minimal detectable change (mdc) 95) of TAMPA SCALE of KINESIOPHOBIA (only on neck pain patients). It's a self-report questionnaire designed to assess pain beliefs and pain-related fear of movement in subjects with musculoskeletal disorders.
PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE
Time frame: re-test at baseline
test-retest absolute reliability (minimal detectable change (mdc) 95) of PAIN AWARENESS AND VIGILANCE QUESTIONNAIRE (only on neck pain patients). It is a self-report questionnaire to measure attention to pain
PITTSBURGH SLEEP QUALITY INDEX
Time frame: re-test at baseline
test-retest absolute reliability (minimal detectable change (mdc) 95) of PITTSBURGH SLEEP QUALITY INDEX (only on neck pain patients). It is a rating scale developed for the purpose of providing a reliable, valid and standardized measure of sleep quality.
18 secondary outcomes
Pain Intensity
Time frame: T0, at the enrollment
Pain Intensity
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Intensity
Time frame: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Time frame: T0, at the enrollment
Self-reported change
Time frame: Third session (T2), after 6 months from enrollment
Self-reported change
Time frame: Second sessions (T1), after 3 month from enrollment
Self-reported change
Time frame: T0, at the enrollment
Medication Use
Time frame: Third session (T2), after 6 months from enrollment
Medication Use
Time frame: Second sessions (T1), after 3 month from enrollment
Medication Use
Time frame: T0, at the enrollment
Pain Frequency
Time frame: Third session (T2), after 6 months from enrollment
Pain Frequency
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Frequency
Time frame: T0, at the enrollment
Health Related Quality of Life
Time frame: Third session (T2), after 6 months from enrollment
Health Related Quality of Life
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)
Time frame: T0, at the enrollment
Pain Catastrophizing Scale (PCS)
Time frame: Second sessions (T1), after 3 month from enrollment
Pain Catastrophizing Scale (PCS)
Time frame: Third session (T2), after 6 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Non-Specific Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
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.
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 Chronic Non-Specific Low Back Pain and Chronic Non-specific Neck Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi (+39 05573931, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Second sessions (T1), after 3 month from enrollment). The study lists 12 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 8 Apr 2025.