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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
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.
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.
Université de Sherbrooke
Sherbrooke, Quebec, Canada
RECRUITINGNumber 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.
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: T2 (through study completion, approximately nine months)
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).
Time frame: 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)
Time frame: 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.
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
Measured by scores on the Fear-Avoidance Beliefs Questionnaire - physical activity subscale (FABQ-PA, 4 items, score ranging from 0 to 24)
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
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.
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
Measured by scores on the Start Back Screening Tool (SBST, 9 items, scores ranging from 0 to 9)
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
Measured by score on the FABQ-work subscale (FABQ-W, 7 items, score ranging from 0 to 42). Higher score indicates worse outcomes.
Time frame: Change in FABQ-W scores at 0, 6 and 12 weeks.
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