Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model

Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial

This study aims to determine the feasibility of conducting a future randomized controlled trial to collect preliminary data on the effectiveness of a previously validated approach that takes into account all the pain and disability vectors 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 future randomized clinical trial to evaluate the impact of the PDDM on the management of non-specific LBP in a clinical setting and to explore the short-term effect of using the model on patient's clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Mechanical Low Back Pain
• Intervention / Treatment: Device: The Low Back Pain and Disability Drivers Management (PDDM) model

Detailed Description

Background: Non-specific mechanical low back pain (LBP) is highly prevalent, recurrent and is a leading cause of disability worldwide. Despite increased efforts in improving care, the self-reported levels of disability in individuals with LBP have not improved in the last decade. In order to more effectively manage LBP through non-pharmacological approaches, evidence endorses the use of classification systems to support diagnosis and guide treatments. However, this approach to care is not without limitations and a more comprehensive and broader perspective is needed. Hence, we recently proposed and validated the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the domains influencing pain and disability to create a profile or phenotype to guide clinical decisions. The objective of this study is to assess the feasibility of conducting a trial and to gather preliminary effect outcomes of the intervention in clinical setting.

Methods: The design is a prospective single arm experimental design. Physiotherapists (PTs) working with a population suffering from musculoskeletal disorders and patients presenting with non-specific mechanical LBP from two different clinical settings will be recruited. The intervention consists of a one-day training workshop for PTs on using the PDDM to guide management decisions. PTs will then perform a 6-weeks follow-up with their participating patients. This feasibility study will assess recruitment and retention rates as well as PTs' acceptability and patients' satisfaction outcomes related to the intervention. Preliminary effect outcomes will also be gathered.

Discussion: This study will inform the feasibility and acceptability of the intervention and gather preliminary outcomes to conduct a future randomized controlled trial to measure the effectiveness of the intervention in managing non-specific mechanical LBP.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2B 1J9
      • Réseau de clinique PhysioExtra
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • CIUSSS de l'Estrie - CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients:

• Patients presenting with non-specific LBP according to the assessment conducted by the PT

Description

Inclusion Criteria:

Clinicians:

• be working with a population suffering from musculoskeletal disorders such as LBP and have a valid license to practice physiotherapy in the province of Quebec
• agree to participate to the one-day training workshop (intervention)
• assess and initiate treatment of their patients presenting with non-specific LBP guided by our newly developed model

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pain and Disability Drivers Management model; Participating clinicians will use the PDDM model to guide assessment and treatment of their patients for a 6-weeks period.

Device: The Low Back Pain and Disability Drivers Management (PDDM) model; The Low Back Pain and Disability Drivers Management (PDDM) model aims to identify the domains influencing pain and disability to guide clinical decisions. 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 (i.e., somatic, inflammatory or mixed pain), 2) nervous system dysfunction (NSD) drivers (i.e., sensitization of the peripheral and/or central nervous system), 3) comorbidity drivers (i.e., physical and/or mental health comorbidities), 4) cognitive-emotional drivers (i.e., maladaptive cognitions and/or behaviors) and 5) contextual drivers (i.e., occupational-related and social environmental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementation	Recruitment rate: % of eligible clinicians who enrolled in the study (T1)	T1: clinician's baseline.
Feasibility of implementation	Retention rate: % of contacted clinicians who accepted to participate and report data (T3-T1)	T1: clinician's baseline; T3 (6 weeks)
Clinician's acceptability of the workshop	Assessed via semi-structured phone interviews. It includes the clinician's appreciation of the training.	T1: clinician's baseline (after the workshop)
Clinician's acceptability of the intervention	Assessed via semi-structured phone interviews and include clinician's perception of suitability of the assessment procedures to refine the diagnosis and to target adequate treatment.	T3 (6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nociceptive pain drivers : Change in Brief Pain Inventory (BPI) scores at 6 weeks	Change in BPI scores measured at T2 and T3 (T3-T2)	At T2: patient initial visit; T3: +6 weeks after initial visit
Nervous system dysfunction drivers: Change in Pain Detect Questionnaire scores at 6 weeks	Change in Pain Detect Questionnaire scores measured at T2 and T3 (T3-T2)	At T2: patient initial visit; T3: +6 weeks after initial visit
Nervous system dysfunction drivers: Change in Central Sensitization Index (CSI) scores at 6 weeks	Change in CSI scores measured at T2 and T3 (T3-T2)	At T2: patient initial visit; T3: +6 weeks after initial visit
Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks	Change in SBT scores measured at T2 and T3 (T3-T2)	At T2: patient initial visit; T3: +6 weeks after initial visit
Contextual drivers: Change in Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) scores at 6 weeks	Change in OMPSQ scores measured at T2 and T3 (T3-T2)	At T2: patient initial visit; T3: +6 weeks after initial visit

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Quebec Pain Research Network
• Investigators: Principal Investigator: Yannick Tousignant-Laflamme, PhD, School of Rehabilitation, University of Sherbrooke

Publications and helpful links

General Publications

• Longtin C, Decary S, Cook CE, Martel MO, Lafrenaye S, Carlesso LC, Naye F, Tousignant-Laflamme Y. Optimizing management of low back pain through the pain and disability drivers management model: A feasibility trial. PLoS One. 2021 Jan 20;16(1):e0245689. doi: 10.1371/journal.pone.0245689. eCollection 2021.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Low back pain; Pain management; Feasibility outcomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MP-31-2019-3131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No