Low Back PainNCT04893369
Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain
A study testing The Low Back Pain and Disability Drivers Management model and Low back pain clinical practice guidelines in people with Low Back Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers associated with low back pain - the Pain and Disability… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- The Low Back Pain and Disability Drivers Management model and Low back pain clinical practice guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2021to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be working with patients presenting with LBP
- be able to participate in a one-day training workshop
- assess and initiate treatment of their LBP patients based on the PDDM model (intervention) or the most recent CPGs (control)
- be fluent in French
- be 18 years or older
- presenting with a primary complaint of LBP
Show all 9Show fewer
- be able to understand and read French
- have access to an email address
- be willing to provide patient-related outcomes measures
Who cannot join
- For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model
- Patients' eligibility criteria:
- Patients not deemed fit for rehabilitation by their therapist (i.e., red flags)
- Patients already undergoing physiotherapy treatment for their episode of LBP
Trial locations and contacts
1 site in 1 country.
Yannick Tousignant-Laflamme, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Christian Longtin, MSc, 1 819-821-0000 ext. 71021, christian.longtin@usherbrooke.ca
Yannick Tousignant-Laflamme, PhD, 1 819-821-8000 ext. 72912, yannick.tousignant-laflamme@usherbrooke.ca
About this study
Official title: Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain - a Pilot Study
This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers associated with low back pain - the Pain and Disability Drivers Management Model (PDDM).
The overall objective is to provide data to assess the feasibility of implementing a multisite pragmatic cluster nonrandomized clinical trial to determine the effectiveness of the PDDM on short-term patient-related outcomes compared to the most recent clinical practice guidelines to improve the management of patients living with low back pain.
Read the detailed description
Rationale: Low back pain (LBP) is highly prevalent, recurrent and is the leading cause of disability among all MSK disorders (1). Evidence endorses the use of clinical practice guidelines (CPGs) to help clinicians establish the diagnosis and guide treatments. Yet, they have shown limitations as they mostly focus on addressing biological deficits and poorly integrate psychosocial factors. Thus, we recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model that aims to identify the domains influencing pain and disability to create a personalized clinical profile facilitating diagnosis, prognostic and treatment options (2).
Aims and hypotheses: 1) To assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and 2) to explore preliminary evidence of the effectiveness of the PDDM model compared to CPGs on short-term patient-related outcomes. We hypothesize that the feasibility of conducting such trial will be confirmed. Our secondary hypothesis is that the PDDM model will lead to better short-term patients' outcomes compared to CPGs.
Methods:
Design: A pilot cluster nonrandomized controlled trial where allocation occurs at the level of the clinics (CONSORT). Physiotherapy clinics from different demographic and administrative settings will be recruited.
Participants: We aim to recruit a minimum of 12 physiotherapists (PT) per group arm with each PT recruiting a minimum of 5 patients within a 9-month timeframe. To be included, PTs will have to 1) be working with LBP patients, 2) be able to participate in a 1-day training workshop and 3) assess and initiate treatment of their patients guided by the PDDM model (intervention group) or CPGs (comparator). Patients 18 years or older presenting with a primary complaint of LBP without serious underlying pathology will be included.
Intervention: PTs in the intervention group will undergo a 1-day workshop on the PDDM model. In the control group, PTs will be blinded to the PDDM and will receive a 1-day training on CPGs for LBP.
Outcomes: Feasibility outcome measures will include: 1) feasibility of trial design and procedures, 2) recruitment and retention rates, 3) suitability of eligibility criteria and 4) fidelity of intervention. Feasibility success criteria will be determined to guide the decision on conducting a future definitive trial. Effectiveness outcomes will be measured by validated self-reported questionnaires, and more precisely by changes in severity and impact of pain on function, nervous system dysfunctions, cognitive-affective and contextual drivers at baseline, 6- and 12-week follow-ups.
Analysis: Descriptive statistics will be used to summarize feasibility outcomes. Quantitative analysis will be conducted using linear mixed models to explore between- and within-group differences.
Discussion: This project will lead to a better understanding of LBP management as well as the effectiveness of the PDDM model, which has the potential to influence clinical practice by integrating prognostic factors and innovative clinical tools (e.g., patient dashboard to document clinical profile).
- Conditions
- Low Back Pain
- Being tested
- The Low Back Pain and Disability Drivers Management model, Low back pain clinical practice guidelines
- Keywords
- Pain management, Rehabilitation, Low back pain
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Low Back Pain and Disability Drivers Management modelOther
PTs assigned to the intervention arm will undergo a one-day training specific to the PDDM model. The objectives of the workshop are 1) to acquire knowledge on the functioning of the PDDM model by identifying the different domains of the model, and the specific elements that are deemed "problematic" for a given patient to appropriately establish the clinical profile and 2) to adopt a structured approach to manage and select appropriate interventions to address problematic areas. The model is composed of five domains upon which the clinician can base his assessment and orientate treatment allocation and includes: 1) nociceptive pain drivers, 2) nervous system dysfunction (NSD) drivers, 3) comorbidity drivers, 4) cognitive-emotional drivers and 5) contextual drivers. This profiling will inform and lead the clinician's treatment approach based on the combined contribution of each domain driving the experience of pain and disability.
Low back pain clinical practice guidelinesOther
For the PTs allocated to the control arm, they will participate in a three-hour training on the most recent CPGs on the management of LBP. The content of the training is based on the results of a thorough review of the literature summarizing the different recommendations from CPGs with a focus on the rehabilitation management of LBP. The objectives of the workshop are 1) to acquire knowledge about the recommendations from the most recent and high-quality CPGs for the management of LBP and 2) to foster their integration into clinical practice. An interactive workshop will be conducted to present the results of the review of the literature with the help of case-studies to facilitate implementation and promote active participation.
| Study group | Role | What they receive |
|---|---|---|
| The Low Back Pain and Disability Drivers Management model | Experimental | Participating clinicians in the intervention arm will use the PDDM model to guide assessment and treatment of their patients and data will be collected over a 12-weeks period. Receives: Other: The Low Back Pain and Disability Drivers Management model |
| Low back pain clinical practice guidelines | Active comparator | Participating clinicians in the active comparator arm will perform assessment and treatment of their patients based on the recommendations from the most recent and high-quality clinical practice guidelines (CPGs) and data will be collected over a 12-weeks period. Receives: Other: Low back pain clinical practice guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited for the study
Overall recruitment of participants during the nine months recruitment period. Recruitment rate defined as % of eligible clinicians who enrolled in the study for each clinic. Clinician/patient recruitment ratio.
Measured: up to nine months.
Retention rate of participants
Measured by attrition rate of the participants : % of patients enrolled in the study but who did not complete the study (e.g., questionnaires, dropped out, lost to follow-up)
Measured: T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)
Suitability of admissibility criteria
Determined based on overall recruitment rate and clinicians' answers to two questions at the end of the study (T2): are the criteria sufficient or too restrictive? Is it obvious who meets and who does not meet the eligibility criteria
Measured: T2 (through study completion, up to nine months)
Clinicians' compliance to study protocol/fidelity of intervention
Assessment of clinician's compliance to the study protocol will include (yes/no): 1) completion of the knowledge and skills assessment following the workshop, and 2) the reporting of five patients' clinical data by the PT according to the PDDM model or CPGs following their initial assessment at baseline (T0).
Measured: T2 (through study completion, approximately nine months)
Secondary outcomes (7)
Change from baseline in severity and impact of pain on function at 12 weeks
Measured by scores on the Brief Pain Inventory (BPI). Pain intensity (4 items) and pain interference (7 items). Scale 0 to 10. Final score is the average score for each section. Higher scores mean worse outcome).
Measured: Change in BPI scores at 0, 6 and 12 weeks.
Change from baseline in nervous system dysfunctions at 12 weeks
Measured by scores on the PAIN detect questionnaire (12 items, score ranging from 0 to 35)
Measured: Change in PAINdetect scores at 0, 6 and 12 weeks.
Change from baseline in nervous system dysfunctions at 12 weeks
Measured by scores on the short version of the Central Sensitization Index (CSI-9). It contains 9 items, scores ranging from 0 to 36. Higher scores indicate worse outcomes.
Measured: Change in CSI-9 scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Measured by scores on the Fear-Avoidance Beliefs Questionnaire - physical activity subscale (FABQ-PA, 4 items, score ranging from 0 to 24)
Measured: Change in FABQ-physical activity scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Measured by scores on the Chronic Pain Self-Efficacy Scale short version (CPSS, 6 items, mean score ranging from 1 to 10). Higher scores indicate better outcomes.
Measured: Change in CPSS scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Measured by scores on the Start Back Screening Tool (SBST, 9 items, scores ranging from 0 to 9)
Measured: Change in SBST scores at 0, 6 and 12 weeks.
Change from baseline in contextual drivers of pain and disability at 12 weeks
Measured by score on the FABQ-work subscale (FABQ-W, 7 items, score ranging from 0 to 42). Higher score indicates worse outcomes.
Measured: Change in FABQ-W scores at 0, 6 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start4 May 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
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 PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm nonrandomized pragmatic cluster clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Tousignant-Laflamme, PhD, Principal investigator, Université de SherbrookeMichel Tousignant, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893369
- Sponsor's protocol ID
- 2021-3524
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longtin C, Lacasse A, Cook CE, Tousignant M, Tousignant-Laflamme Y. Management of low back pain by primary care physiotherapists using the pain and disability drivers management model: An improver analysis. Musculoskeletal Care. 2023 Sep;21(3):916-925. doi: 10.1002/msc.1742. Epub 2023 Feb 10. No abstract available.
PubMed 36762893Longtin C, Decary S, Cook CE, Tousignant M, Lacasse A, Tousignant-Laflamme Y. Optimising management of low back pain through the pain and disability drivers management model: Findings from a pilot cluster nonrandomised controlled trial. Musculoskeletal Care. 2023 Sep;21(3):667-682. doi: 10.1002/msc.1738. Epub 2023 Feb 7.
PubMed 36749025
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain - a Pilot Study
- ClinicalTrials.gov ID
- NCT04893369
- Acronym / sponsor ID
- 2021-3524
- Conditions
- Low Back Pain
- Keywords
- Pain management, Rehabilitation, Low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 May 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.
This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers associated with low back pain - the Pain and Disability Drivers Management Model (PDDM).
The overall objective is to provide data to assess the feasibility of implementing a multisite pragmatic cluster nonrandomized clinical trial to determine the effectiveness of the PDDM on short-term patient-related outcomes compared to the most recent clinical practice guidelines to improve the management of patients living with low back pain.
Detailed description
Rationale: Low back pain (LBP) is highly prevalent, recurrent and is the leading cause of disability among all MSK disorders (1). Evidence endorses the use of clinical practice guidelines (CPGs) to help clinicians establish the diagnosis and guide treatments. Yet, they have shown limitations as they mostly focus on addressing biological deficits and poorly integrate psychosocial factors. Thus, we recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model that aims to identify the domains influencing pain and disability to create a personalized clinical profile facilitating diagnosis, prognostic and treatment options (2).
Aims and hypotheses: 1) To assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and 2) to explore preliminary evidence of the effectiveness of the PDDM model compared to CPGs on short-term patient-related outcomes. We hypothesize that the feasibility of conducting such trial will be confirmed. Our secondary hypothesis is that the PDDM model will lead to better short-term patients' outcomes compared to CPGs.
Methods:
Design: A pilot cluster nonrandomized controlled trial where allocation occurs at the level of the clinics (CONSORT). Physiotherapy clinics from different demographic and administrative settings will be recruited.
Participants: We aim to recruit a minimum of 12 physiotherapists (PT) per group arm with each PT recruiting a minimum of 5 patients within a 9-month timeframe. To be included, PTs will have to 1) be working with LBP patients, 2) be able to participate in a 1-day training workshop and 3) assess and initiate treatment of their patients guided by the PDDM model (intervention group) or CPGs (comparator). Patients 18 years or older presenting with a primary complaint of LBP without serious underlying pathology will be included.
Intervention: PTs in the intervention group will undergo a 1-day workshop on the PDDM model. In the control group, PTs will be blinded to the PDDM and will receive a 1-day training on CPGs for LBP.
Outcomes: Feasibility outcome measures will include: 1) feasibility of trial design and procedures, 2) recruitment and retention rates, 3) suitability of eligibility criteria and 4) fidelity of intervention. Feasibility success criteria will be determined to guide the decision on conducting a future definitive trial. Effectiveness outcomes will be measured by validated self-reported questionnaires, and more precisely by changes in severity and impact of pain on function, nervous system dysfunctions, cognitive-affective and contextual drivers at baseline, 6- and 12-week follow-ups.
Analysis: Descriptive statistics will be used to summarize feasibility outcomes. Quantitative analysis will be conducted using linear mixed models to explore between- and within-group differences.
Discussion: This project will lead to a better understanding of LBP management as well as the effectiveness of the PDDM model, which has the potential to influence clinical practice by integrating prognostic factors and innovative clinical tools (e.g., patient dashboard to document clinical profile).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm nonrandomized pragmatic cluster clinical trial
| Arm | Type | Receives |
|---|---|---|
| The Low Back Pain and Disability Drivers Management model | Experimental | Other: The Low Back Pain and Disability Drivers Management modelParticipating clinicians in the intervention arm will use the PDDM model to guide assessment and treatment of their patients and data will be collected over a 12-weeks period. |
| Low back pain clinical practice guidelines | Active comparator | Other: Low back pain clinical practice guidelinesParticipating clinicians in the active comparator arm will perform assessment and treatment of their patients based on the recommendations from the most recent and high-quality clinical practice guidelines (CPGs) and data will be collected over a 12-weeks period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be working with patients presenting with LBP
- be able to participate in a one-day training workshop
- assess and initiate treatment of their LBP patients based on the PDDM model (intervention) or the most recent CPGs (control)
- be fluent in French
- be 18 years or older
Key exclusion criteria (4 listed)
- For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model
- Patients not deemed fit for rehabilitation by their therapist (i.e., red flags)
- Patients already undergoing physiotherapy treatment for their episode of LBP
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 |
|---|---|---|
| The Low Back Pain and Disability Drivers Management modelPTs assigned to the intervention arm will undergo a one-day training specific to the PDDM model. The objectives of the workshop are 1) to acquire knowledge on the functioning of the PDDM model by identifying the different domains of the model, and the specific elements that are deemed "problematic" for a given patient to appropriately establish the clinical profile and 2) to adopt a structured approach to manage and select appropriate interventions to address problematic areas. The model is composed of five domains upon which the clinician can base his assessment and orientate treatment allocation and includes: 1) nociceptive pain drivers, 2) nervous system dysfunction (NSD) drivers, 3) comorbidity drivers, 4) cognitive-emotional drivers and 5) contextual drivers. This profiling will inform and lead the clinician's treatment approach based on the combined contribution of each domain driving the experience of pain and disability. | Other | The Low Back Pain and Disability Drivers Management model |
| Low back pain clinical practice guidelinesFor the PTs allocated to the control arm, they will participate in a three-hour training on the most recent CPGs on the management of LBP. The content of the training is based on the results of a thorough review of the literature summarizing the different recommendations from CPGs with a focus on the rehabilitation management of LBP. The objectives of the workshop are 1) to acquire knowledge about the recommendations from the most recent and high-quality CPGs for the management of LBP and 2) to foster their integration into clinical practice. An interactive workshop will be conducted to present the results of the review of the literature with the help of case-studies to facilitate implementation and promote active participation. | Other | Low back pain clinical practice guidelines |
Primary outcome
Number of participants recruited for the study
Time frame: up to nine months.
Overall recruitment of participants during the nine months recruitment period. Recruitment rate defined as % of eligible clinicians who enrolled in the study for each clinic. Clinician/patient recruitment ratio.
Retention rate of participants
Time frame: T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)
Measured by attrition rate of the participants : % of patients enrolled in the study but who did not complete the study (e.g., questionnaires, dropped out, lost to follow-up)
Suitability of admissibility criteria
Time frame: T2 (through study completion, up to nine months)
Determined based on overall recruitment rate and clinicians' answers to two questions at the end of the study (T2): are the criteria sufficient or too restrictive? Is it obvious who meets and who does not meet the eligibility criteria
Clinicians' compliance to study protocol/fidelity of intervention
Time frame: T2 (through study completion, approximately nine months)
Assessment of clinician's compliance to the study protocol will include (yes/no): 1) completion of the knowledge and skills assessment following the workshop, and 2) the reporting of five patients' clinical data by the PT according to the PDDM model or CPGs following their initial assessment at baseline (T0).
7 secondary outcomes
Change from baseline in severity and impact of pain on function at 12 weeks
Time frame: Change in BPI scores at 0, 6 and 12 weeks.
Change from baseline in nervous system dysfunctions at 12 weeks
Time frame: Change in PAINdetect scores at 0, 6 and 12 weeks.
Change from baseline in nervous system dysfunctions at 12 weeks
Time frame: Change in CSI-9 scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Time frame: Change in FABQ-physical activity scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Time frame: Change in CPSS scores at 0, 6 and 12 weeks.
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
Time frame: Change in SBST scores at 0, 6 and 12 weeks.
Change from baseline in contextual drivers of pain and disability at 12 weeks
Time frame: Change in FABQ-W scores at 0, 6 and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Derived from this study: PubMed 36762893Longtin C, Lacasse A, Cook CE, Tousignant M, Tousignant-Laflamme Y. Management of low back pain by primary care physiotherapists using the pain and disability drivers management model: An improver analysis. Musculoskeletal Care. 2023 Sep;21(3):916-925. doi: 10.1002/msc.1742. Epub 2023 Feb 10. No abstract available.
- Derived from this study: PubMed 36749025Longtin C, Decary S, Cook CE, Tousignant M, Lacasse A, Tousignant-Laflamme Y. Optimising management of low back pain through the pain and disability drivers management model: Findings from a pilot cluster nonrandomised controlled trial. Musculoskeletal Care. 2023 Sep;21(3):667-682. doi: 10.1002/msc.1738. Epub 2023 Feb 7.
- Description: Website (online resource) linked to the study that will be available to the participating clinicians in order to facilitate their use of the PDDM modelLink provided by the sponsor.
- 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.
Yannick Tousignant-Laflamme, PhD contact
Yannick Tousignant-Laflamme, PhD principal investigator
Université de Sherbrooke
Michel Tousignant, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Low Back Pain and Disability Drivers Management model and Low back pain clinical practice guidelines in people with Low Back Pain, run by Université de Sherbrooke 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 9 inclusion and 4 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 28 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Longtin, MSc (1 819 821-8000 ext. 71021, christian.longtin@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited for the study (time frame: up to nine months.). The study lists 4 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 NCT04893369, 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 28 May 2021.