Clinical trial NCT04893369: Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain
Official title: Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Pain management
Rehabilitation
Low back pain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm nonrandomized pragmatic cluster clinical trial
Primary purpose: TREATMENT

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).

Eligibility criteria: Clinicians' eligibility criteria:

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants recruited for the study
timeFrame: up to nine months.
measure: Retention rate of participants
timeFrame: T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)
measure: Suitability of admissibility criteria
timeFrame: T2 (through study completion, up to nine months)
measure: Clinicians' compliance to study protocol/fidelity of intervention
timeFrame: T2 (through study completion, approximately nine months)
Secondary outcomes:
measure: Change from baseline in severity and impact of pain on function at 12 weeks
timeFrame: Change in BPI scores at 0, 6 and 12 weeks.
measure: Change from baseline in nervous system dysfunctions at 12 weeks
timeFrame: Change in PAINdetect scores at 0, 6 and 12 weeks.
measure: Change from baseline in nervous system dysfunctions at 12 weeks
timeFrame: Change in CSI-9 scores at 0, 6 and 12 weeks.
measure: Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
timeFrame: Change in FABQ-physical activity scores at 0, 6 and 12 weeks.
measure: Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
timeFrame: Change in CPSS scores at 0, 6 and 12 weeks.
measure: Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks
timeFrame: Change in SBST scores at 0, 6 and 12 weeks.
measure: Change from baseline in contextual drivers of pain and disability at 12 weeks
timeFrame: Change in FABQ-W scores at 0, 6 and 12 weeks.
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Yannick Tousignant-Laflamme, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Michel Tousignant, PhD
role: PRINCIPAL_INVESTIGATOR
References: