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

NCT03949179 | Completed DMC

• 1 other identifier: MP-31-2019-3131
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Mechanical Low Back Pain

Keywords

Low back pain; Pain management; Rehabilitation; Feasibility outcomes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Nociceptive pain drivers : Change in Brief Pain Inventory (BPI) scores at 6 weeks

  At T2: patient initial visit; T3: +6 weeks after initial visit

• Nervous system dysfunction drivers: Change in Pain Detect Questionnaire scores at 6 weeks

  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

  At T2: patient initial visit; T3: +6 weeks after initial visit

• Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks

  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

  At T2: patient initial visit; T3: +6 weeks after initial visit

Study Arms (1)

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

Interventions

The Low Back Pain and Disability Drivers Management (PDDM) model DEVICE

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.

Pain and Disability Drivers Management model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Quebec Pain Research Network: collaborator

Study Sites (2)

Réseau de clinique PhysioExtra

Montreal, Quebec, H2B 1J9, Canada

Location

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Related Publications (1)

• 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.

  PMID: 33471827 DERIVED

Related 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

MeSH Terms

Conditions

Low Back Pain; Agnosia

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Yannick Tousignant-Laflamme, PhD

  School of Rehabilitation, University of Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 14, 2019
• Study Start: May 3, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)