Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Low back pain clinical practice guidelinesOther: The Low Back Pain and Disability Drivers Management model
- Registration Number
- NCT04893369
- Lead Sponsor
- Université de Sherbrooke
- Brief 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 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- 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
- For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model
Patients' eligibility criteria:
Inclusion Criteria:
- 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 not deemed fit for rehabilitation by their therapist (i.e., red flags)
- Patients already undergoing physiotherapy treatment for their episode of LBP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low back pain clinical practice guidelines 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. The Low Back Pain and Disability Drivers Management model 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.
- Primary Outcome Measures
Name Time Method Number of participants recruited for the study 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 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 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 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).
- Secondary Outcome Measures
Name Time Method Change from baseline in nervous system dysfunctions at 12 weeks Change in CSI-9 scores at 0, 6 and 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.
Change from baseline in severity and impact of pain on function at 12 weeks Change in BPI scores at 0, 6 and 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).
Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks Change in SBST scores at 0, 6 and 12 weeks. Measured by scores on the Start Back Screening Tool (SBST, 9 items, scores ranging from 0 to 9)
Change from baseline in contextual drivers of pain and disability at 12 weeks Change in FABQ-W scores at 0, 6 and 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.
Trial Locations
- Locations (1)
Université de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada