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

Mechanical Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949179
• Other study ID #: MP-31-2019-3131
• Status: Completed
• Start date: May 3, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: March 2020
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Réseau de clinique PhysioExtra	Montréal	Quebec
Canada	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Quebec Pain Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementation	Recruitment rate: % of eligible clinicians who enrolled in the study (T1)	T1: clinician's baseline.
Primary	Feasibility of implementation	Retention rate: % of contacted clinicians who accepted to participate and report data (T3-T1)	T1: clinician's baseline; T3 (6 weeks)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External 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