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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949179
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Quebec Pain Research Network
Information provided by (Responsible Party):
Université de Sherbrooke

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.


Condition or disease Intervention/treatment
Mechanical Low Back Pain 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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial
Actual Study Start Date : May 3, 2019
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949179


Locations
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Canada, Quebec
Réseau de clinique PhysioExtra
Montréal, Quebec, Canada, H2B 1J9
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada, J1H 5H3
Sponsors and Collaborators
Université de Sherbrooke
Quebec Pain Research Network
Investigators
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Principal Investigator: Yannick Tousignant-Laflamme, PhD School of Rehabilitation, University of Sherbrooke
Additional Information:
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03949179    
Other Study ID Numbers: MP-31-2019-3131
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Université de Sherbrooke:
Low back pain
Pain management
Rehabilitation
Feasibility outcomes
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations