Clinical trial NCT03949179: Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model
Official title: Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Low Back Pain
Keywords: Low back pain
Pain management
Rehabilitation
Feasibility outcomes
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Quebec Pain Research Network
First posted: 2019-05-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients:

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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementation
timeFrame: T1: clinician's baseline.
measure: Feasibility of implementation
timeFrame: T1: clinician's baseline; T3 (6 weeks)
measure: Clinician's acceptability of the workshop
timeFrame: T1: clinician's baseline (after the workshop)
measure: Clinician's acceptability of the intervention
timeFrame: T3 (6 weeks)
Secondary outcomes:
measure: Nociceptive pain drivers : Change in Brief Pain Inventory (BPI) scores at 6 weeks
timeFrame: At T2: patient initial visit; T3: +6 weeks after initial visit
measure: Nervous system dysfunction drivers: Change in Pain Detect Questionnaire scores at 6 weeks
timeFrame: At T2: patient initial visit; T3: +6 weeks after initial visit
measure: Nervous system dysfunction drivers: Change in Central Sensitization Index (CSI) scores at 6 weeks
timeFrame: At T2: patient initial visit; T3: +6 weeks after initial visit
measure: Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks
timeFrame: At T2: patient initial visit; T3: +6 weeks after initial visit
measure: Contextual drivers: Change in Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) scores at 6 weeks
timeFrame: At T2: patient initial visit; T3: +6 weeks after initial visit
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Réseau de clinique PhysioExtra
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: School of Rehabilitation, University of Sherbrooke
name: Yannick Tousignant-Laflamme, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.