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Completed

NCT Number: NCT03949179

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Réseau de clinique PhysioExtra, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of implementation

    Time frame: T1: clinician's baseline.

    Recruitment rate: % of eligible clinicians who enrolled in the study (T1)

  2. Feasibility of implementation

    Time frame: T1: clinician's baseline; T3 (6 weeks)

    Retention rate: % of contacted clinicians who accepted to participate and report data (T3-T1)

  3. Clinician's acceptability of the workshop

    Time frame: T1: clinician's baseline (after the workshop)

    Assessed via semi-structured phone interviews. It includes the clinician's appreciation of the training.

  4. Clinician's acceptability of the intervention

    Time frame: T3 (6 weeks)

    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.

Secondary outcomes

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

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

    Change in BPI scores measured at T2 and T3 (T3-T2)

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

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

    Change in Pain Detect Questionnaire scores measured at T2 and T3 (T3-T2)

  3. Nervous system dysfunction drivers: Change in Central Sensitization Index (CSI) scores at 6 weeks

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

    Change in CSI scores measured at T2 and T3 (T3-T2)

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

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

    Change in SBT scores measured at T2 and T3 (T3-T2)

  5. Contextual drivers: Change in Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) scores at 6 weeks

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

    Change in OMPSQ scores measured at T2 and T3 (T3-T2)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Quebec Pain Research Network

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 14, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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