Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain

Low Back Pain Clinical Trial

Official title:

Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893369
• Other study ID #: 2021-3524
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: May 2022

Study information

• Verified date: May 2021
• Source: Université de Sherbrooke
• Contact: Christian Longtin, MSc
• Phone: 1 819 821-8000
• Email: christian.longtin[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to nine months.
Primary	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)	T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)
Primary	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	T2 (through study completion, up to nine months)
Primary	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).	T2 (through study completion, approximately nine months)
Secondary	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).	Change in BPI scores at 0, 6 and 12 weeks.
Secondary	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)	Change in PAINdetect scores at 0, 6 and 12 weeks.
Secondary	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.	Change in CSI-9 scores at 0, 6 and 12 weeks.
Secondary	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)	Change in FABQ-physical activity scores at 0, 6 and 12 weeks.
Secondary	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.	Change in CPSS scores at 0, 6 and 12 weeks.
Secondary	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)	Change in SBST scores at 0, 6 and 12 weeks.
Secondary	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.	Change in FABQ-W scores at 0, 6 and 12 weeks.

External Links

•   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