Low Back Pain, RecurrentNCT04979403
Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
A study testing Physiotherapy in people with Low Back Pain, Recurrent, run by Laval University at 1 site in Canada.
Trial summary
Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 30 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific chronic low back pain (> 3 months)
- High level of psychosocial factors (a high level using the Start Back Screening Tool, i.e., cut-off of at least 4 points (total score) and at least 4 points (sub-score with questions 5 to 9)).
Who cannot join
- Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, infection)
- Neuropathic conditions (e.g., radiculopathy).
- Currently in litigation with paying agencies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, G1M 2S8
About this study
Official title: Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients With Chronic Low Back Pain With a High Level of Psychosocial Factors: a Feasibility and Pilot Randomized Clinical Trial
Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. The main aim of this project is to determine the feasibility to perform a large clinical trial comparing the efficacy of a two physiotherapy's approaches to treat CLBP (i.e., a psychologically-informed physiotherapy intervention compared to usual physiotherapy) in patients with CLBP presenting a high level of psychological factors.
Read the detailed description
Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. Empowerment of physiotherapists and patients on the optimal management of psychosocial factors, in addition of the usual care delivered in physiotherapy, may be a potent strategy to improve the treatment effect especially with patients presenting a complex clinical profile. This empowerment may be done through psychologically-informed physiotherapy, an approach incorporating strategies from cognitive behavioral therapy into the physiotherapy usual practice. However, the feasibility to perform a clinical trial including psychologically-informed physiotherapy in the context of the Quebec's healthcare system remains to be verified.
The main aim of this project is to determine the feasibility to perform a pilot randomised controlled trial testing the efficacy of a psychologically-informed physiotherapy intervention in CLBP patients with a high level of psychosocial factors compared to usual physiotherapy. Specific aims are related to feasibility (1) and sample size estimation (2):
- To test (a) strategies to recruit participants with high level of psychosocial factors and physiotherapists (PT) (recruitment rate and retention), (b) the physiotherapists and participants adherence to intervention, (c) the risk of contamination between treatment sites and (d) specific challenges;
- To gather data to estimate the required sample size for a future full-scale randomized clinical trial using physical functioning as main outcome, and pain intensity, quality of life, fear of movement, catastrophizing, self-efficacy, pain pressure threshold, exercise-induced hypoalgesia and temporal summation as additional outcomes.
The hypothesis is that this project will be feasible in terms of recruitment for both patients (~30) and PT (6-8), will show good patients and physiotherapists' adherence to intervention and low contamination between treatment sites. An improvement for all pain-related outcomes in both groups, but more in the psychologically-informed physiotherapy group, is also expected.
- Conditions
- Low Back Pain, Recurrent
- Being tested
- Physiotherapy
- Keywords
- Chronic low back pain, Psychosocial factors, Physiotherapy, Interventions
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Participants from each group will receive 8 intervention sessions (45 min) over 11 weeks by a physiotherapist. For both groups, each intervention will be tailored to the patient's profile and the choice of interventions and parameters will be at the judgment of the physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Usual care in physiotherapy | Active comparator | The usual care group will receive interventions recommended by clinical guidelines: education on the nature of LBP, advice to stay active and to continue usual activities, specific exercise programs combined with orthopedic manual therapy. Receives: Other: Physiotherapy |
| Psychologically-informed physiotherapy intervention | Experimental | The psychologically-informed physiotherapy group will receive the control intervention enhanced with specific interventions targeting psychosocial factors (e.g., positive reinforcement, mindfulness-based stress reduction, diaphragmatic breathing, graded exposure). Most of these techniques are efficient to mitigate the impact of psychological factors such as anxiety and fear of movement. To standardize the psychologically-informed physiotherapy approach, physiotherapists will receive a two-day training course by a physiotherapist expert with this approach in chronic pain conditions (Alain Gaumond). Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate of participants
The number of participants contacted divided by the number of participants recruited.
Measured: Baseline
Physiotherapists adherence to intervention
Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).
Measured: Week 6
Risk of contamination between treatment sites
The list of interventions used by physiotherapists at each site will be compared to evaluate the risk of contamination between treatment sites.
Measured: Week 6
Specific challenges
Using semi-structured interview with the physio.
Measured: Through data collection completion, an average of 1 year
Retention of participants
The number of participants who completed the study divided by the number of participants that were recruited.
Measured: Baseline, when a participant drop out
Participants adherence to intervention
Participants will measure their adherence to intervention on a Numeric Rating Scale from 0 (not adherent at all) to 10 (completely adherent).
Measured: Week 6
Secondary outcomes (11)
Physical functioning (ODI)
The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability).
Measured: Baseline, Weeks 6, 12 and 24
Pain intensity (NRS)
The Numeric Rating Scale (NRS) is an 11-point scale used to score the intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, Weeks 6, 12 and 24
Quality of life (SF-12)
The 12-Item Short Form Survey is a self-completed questionnaire counting 12 questions on eight mental and physical health domains. The score is calculated by a specific calculator that compares the score to the general population.
Measured: Baseline, Weeks 6, 12 and 24
Fear of movement (TSK-11)
The Tampa Scale of Kinesiophobia is a self-completed questionnaire used to assess fear of movement using 11 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).
Measured: Baseline, Weeks 6, 12 and 24
Catastrophizing thoughts (PCS)
The Pain Catastrophizing Scale (PCS) is a self-completed questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).
Measured: Baseline, Weeks 6, 12 and 24
Self-efficacy (CPSES)
The Chronic Pain Self-Efficacy Scale (CPSES) (short form) is a self-completed questionnaire of 6 questions measuring self-efficacy on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).
Measured: Baseline, Weeks 6, 12 and 24
Participant's expectations
Participant's expectations regarding treatment will be measured with a self-completed questionnaire of three 7-level Likert questions on pain, physical functioning and participation ranging from 0 (way better) to 6 (way worst).
Measured: Baseline, Weeks 6, 12 and 24
Central Sensitization (CSI)
The Central Sensitization Index (CSI) is a self-completed questionnaire of 9 questions measuring central sensitization on a 5-point scale from 0 (never, low level of central sensitization) to 5 (always, high level of central sensitization).
Measured: Baseline, Weeks 6, 12 and 24
Global rating of change (GRC)
The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change oh health status after the intervention.
Measured: Baseline, Weeks 6, 12 and 24
Pain pressure threshold
Pain pressure thresholds will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a digital algometer before and after an exercise of wrist flexion (maintaining 25% of the maximal voluntary contraction activity during 4 minutes) to test the exercise-induced hypoalgesia paradigm.
Measured: Baseline, Week 6
Temporal summation
Temporal summations will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a pinprick before the exercise of wrist flexion.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Sep 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a feasibility and pilot randomized clinical trial. Participants will be assigned to either the psychologically-informed physiotherapy intervention or to the usual care in physiotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Fonds de la Recherche en Santé du Québec, Ordre professionnel de la physiothérapie du Québec
- Responsible party
- Principal investigator, Hugo Massé-Alarie, Laval University
- Investigators
- Hugo Massé-Alarie, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979403
- Sponsor's protocol ID
- 2021-2227
- Status last verified
- Feb 2026
- First submitted
- 14 Jun 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (of all primary and secondary outcomes) will be available in a supplementary table when publishing the results of the study.
Publications
Masse-Alarie H, Desgagnes A, Cote-Picard C, Liberty O, Langevin P, Piche M, Tousignant-Laflamme Y. Comparisons of the effects of psychologically-informed and usual physiotherapy on pain sensitivity in chronic low back pain: an exploratory randomized controlled trial. Arch Physiother. 2025 Feb 17;15:32-41. doi: 10.33393/aop.2025.3323. eCollection 2025 Jan-Dec.
PubMed 39974748Desgagnes A, Cote-Picard C, Gaumond A, Langevin P, Piche M, Page G, Pinard AM, Tousignant-Laflamme Y, Masse-Alarie H. Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients with Chronic Low Back Pain at High Risk of Poor Prognosis: A Pilot and Feasibility Randomized Controlled Trial. Physiother Can. 2024 May 8;76(2):163-174. doi: 10.3138/ptc-2023-0038. eCollection 2024 May.
PubMed 38725600
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients With Chronic Low Back Pain With a High Level of Psychosocial Factors: a Feasibility and Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04979403
- Acronym / sponsor ID
- 2021-2227
- Conditions
- Low Back Pain, Recurrent
- Keywords
- Chronic low back pain, Psychosocial factors, Physiotherapy, Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Fonds de la Recherche en Santé du Québec, Ordre professionnel de la physiothérapie du Québec
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 28 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.
Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. The main aim of this project is to determine the feasibility to perform a large clinical trial comparing the efficacy of a two physiotherapy's approaches to treat CLBP (i.e., a psychologically-informed physiotherapy intervention compared to usual physiotherapy) in patients with CLBP presenting a high level of psychological factors.
Detailed description
Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. Empowerment of physiotherapists and patients on the optimal management of psychosocial factors, in addition of the usual care delivered in physiotherapy, may be a potent strategy to improve the treatment effect especially with patients presenting a complex clinical profile. This empowerment may be done through psychologically-informed physiotherapy, an approach incorporating strategies from cognitive behavioral therapy into the physiotherapy usual practice. However, the feasibility to perform a clinical trial including psychologically-informed physiotherapy in the context of the Quebec's healthcare system remains to be verified.
The main aim of this project is to determine the feasibility to perform a pilot randomised controlled trial testing the efficacy of a psychologically-informed physiotherapy intervention in CLBP patients with a high level of psychosocial factors compared to usual physiotherapy. Specific aims are related to feasibility (1) and sample size estimation (2):
- To test (a) strategies to recruit participants with high level of psychosocial factors and physiotherapists (PT) (recruitment rate and retention), (b) the physiotherapists and participants adherence to intervention, (c) the risk of contamination between treatment sites and (d) specific challenges;
- To gather data to estimate the required sample size for a future full-scale randomized clinical trial using physical functioning as main outcome, and pain intensity, quality of life, fear of movement, catastrophizing, self-efficacy, pain pressure threshold, exercise-induced hypoalgesia and temporal summation as additional outcomes.
The hypothesis is that this project will be feasible in terms of recruitment for both patients (~30) and PT (6-8), will show good patients and physiotherapists' adherence to intervention and low contamination between treatment sites. An improvement for all pain-related outcomes in both groups, but more in the psychologically-informed physiotherapy group, is also expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a feasibility and pilot randomized clinical trial. Participants will be assigned to either the psychologically-informed physiotherapy intervention or to the usual care in physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Usual care in physiotherapy | Active comparator | Other: PhysiotherapyThe usual care group will receive interventions recommended by clinical guidelines: education on the nature of LBP, advice to stay active and to continue usual activities, specific exercise programs combined with orthopedic manual therapy. |
| Psychologically-informed physiotherapy intervention | Experimental | Other: PhysiotherapyThe psychologically-informed physiotherapy group will receive the control intervention enhanced with specific interventions targeting psychosocial factors (e.g., positive reinforcement, mindfulness-based stress reduction, diaphragmatic breathing, graded exposure). Most of these techniques are efficient to mitigate the impact of psychological factors such as anxiety and fear of movement. To standardize the psychologically-informed physiotherapy approach, physiotherapists will receive a two-day training course by a physiotherapist expert with this approach in chronic pain conditions (Alain Gaumond). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-specific chronic low back pain (> 3 months)
- High level of psychosocial factors (a high level using the Start Back Screening Tool, i.e., cut-off of at least 4 points (total score) and at least 4 points (sub-score with questions 5 to 9)).
Key exclusion criteria (3 listed)
- Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, infection)
- Neuropathic conditions (e.g., radiculopathy).
- Currently in litigation with paying agencies
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 |
|---|---|---|
| PhysiotherapyParticipants from each group will receive 8 intervention sessions (45 min) over 11 weeks by a physiotherapist. For both groups, each intervention will be tailored to the patient's profile and the choice of interventions and parameters will be at the judgment of the physiotherapist. | Other | Psychologically-informed physiotherapy intervention, Usual care in physiotherapy |
Primary outcome
Recruitment rate of participants
Time frame: Baseline
The number of participants contacted divided by the number of participants recruited.
Physiotherapists adherence to intervention
Time frame: Week 6
Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).
Risk of contamination between treatment sites
Time frame: Week 6
The list of interventions used by physiotherapists at each site will be compared to evaluate the risk of contamination between treatment sites.
Specific challenges
Time frame: Through data collection completion, an average of 1 year
Using semi-structured interview with the physio.
Retention of participants
Time frame: Baseline, when a participant drop out
The number of participants who completed the study divided by the number of participants that were recruited.
Participants adherence to intervention
Time frame: Week 6
Participants will measure their adherence to intervention on a Numeric Rating Scale from 0 (not adherent at all) to 10 (completely adherent).
11 secondary outcomes
Physical functioning (ODI)
Time frame: Baseline, Weeks 6, 12 and 24
Pain intensity (NRS)
Time frame: Baseline, Weeks 6, 12 and 24
Quality of life (SF-12)
Time frame: Baseline, Weeks 6, 12 and 24
Fear of movement (TSK-11)
Time frame: Baseline, Weeks 6, 12 and 24
Catastrophizing thoughts (PCS)
Time frame: Baseline, Weeks 6, 12 and 24
Self-efficacy (CPSES)
Time frame: Baseline, Weeks 6, 12 and 24
Participant's expectations
Time frame: Baseline, Weeks 6, 12 and 24
Central Sensitization (CSI)
Time frame: Baseline, Weeks 6, 12 and 24
Global rating of change (GRC)
Time frame: Baseline, Weeks 6, 12 and 24
Pain pressure threshold
Time frame: Baseline, Week 6
Temporal summation
Time frame: Baseline, Week 6
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 12 Feb 2026.
- Results publication: PubMed 39974748Masse-Alarie H, Desgagnes A, Cote-Picard C, Liberty O, Langevin P, Piche M, Tousignant-Laflamme Y. Comparisons of the effects of psychologically-informed and usual physiotherapy on pain sensitivity in chronic low back pain: an exploratory randomized controlled trial. Arch Physiother. 2025 Feb 17;15:32-41. doi: 10.33393/aop.2025.3323. eCollection 2025 Jan-Dec.
- Results publication: PubMed 38725600Desgagnes A, Cote-Picard C, Gaumond A, Langevin P, Piche M, Page G, Pinard AM, Tousignant-Laflamme Y, Masse-Alarie H. Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients with Chronic Low Back Pain at High Risk of Poor Prognosis: A Pilot and Feasibility Randomized Controlled Trial. Physiother Can. 2024 May 8;76(2):163-174. doi: 10.3138/ptc-2023-0038. eCollection 2024 May.
- Individual participant dataSharing planned: Yes. Individual participant data (of all primary and secondary outcomes) will be available in a supplementary table when publishing 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.
Hugo Massé-Alarie, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Low Back Pain, Recurrent, run by Laval University at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 12 Feb 2026. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate of participants (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979403, which also lists 2 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 12 Feb 2026.