Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain
NCT ID: NCT04893369
Last Updated: 2021-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2021-05-04
2022-05-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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The Low Back Pain and Disability Drivers Management model
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.
The Low Back Pain and Disability Drivers Management model
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 guidelines
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.
Low back pain clinical practice guidelines
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.
Interventions
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The Low Back Pain and Disability Drivers Management model
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 guidelines
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* be able to understand and read French
* have access to an email address
* be willing to provide patient-related outcomes measures
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Principal Investigators
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Yannick Tousignant-Laflamme, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Michel Tousignant, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Université de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Christian Longtin, MSc
Role: primary
Yannick Tousignant-Laflamme, PhD
Role: backup
References
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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.
Longtin 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.
Related Links
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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 model
Other Identifiers
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2021-3524
Identifier Type: -
Identifier Source: org_study_id