Recruiting

Pain Management

Sponsor:

Université de Sherbrooke

Code:

NCT04893369

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The Low Back Pain and Disability Drivers Management model

Low back pain clinical practice guidelines

Study Details

Brief summary:

This study aims to assess the feasibility of procedures for conducting a pragmatic cluster nonrandomized controlled trial and to collect data on the effectiveness of a previously validated approach that takes into account all the pain and disability drivers 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 multisite pragmatic cluster nonrandomized clinical trial to determine the effectiveness of the PDDM on short-term patient-related outcomes compared to the most recent clinical practice guidelines to improve the management of patients living with low back pain.

Conditions

Low Back Pain

Study ID

NCT04893369

Start date

May 4, 2021

Status verified date

May, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Clinicians' eligibility criteria:

Inclusion Criteria:

  • be working with patients presenting with LBP
  • be able to participate in a one-day training workshop
  • assess and initiate treatment of their LBP patients based on the PDDM model (intervention) or the most recent CPGs (control)
  • be fluent in French

Exclusion Criteria:

  • For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model

Patients' eligibility criteria:

Inclusion Criteria:

  • be 18 years or older
  • presenting with a primary complaint of LBP
  • be able to understand and read French
  • have access to an email address
  • be willing to provide patient-related outcomes measures

Exclusion Criteria:

  • Patients not deemed fit for rehabilitation by their therapist (i.e., red flags)
  • Patients already undergoing physiotherapy treatment for their episode of LBP

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The Low Back Pain and Disability Drivers Management model

Participating clinicians in the intervention arm will use the PDDM model to guide assessment and treatment of their patients and data will be collected over a 12-weeks period.

active comparator: Low back pain clinical practice guidelines

Participating clinicians in the active comparator arm will perform assessment and treatment of their patients based on the recommendations from the most recent and high-quality clinical practice guidelines (CPGs) and data will be collected over a 12-weeks period.

Interventions

The Low Back Pain and Disability Drivers Management model

PTs assigned to the intervention arm will undergo a one-day training specific to the PDDM model. The objectives of the workshop are 1) to acquire knowledge on the functioning of the PDDM model by identifying the different domains of the model, and the specific elements that are deemed "problematic" for a given patient to appropriately establish the clinical profile and 2) to adopt a structured approach to manage and select appropriate interventions to address problematic areas. 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, 2) nervous system dysfunction (NSD) drivers, 3) comorbidity drivers, 4) cognitive-emotional drivers and 5) 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.

Low back pain clinical practice guidelines

For the PTs allocated to the control arm, they will participate in a three-hour training on the most recent CPGs on the management of LBP. The content of the training is based on the results of a thorough review of the literature summarizing the different recommendations from CPGs with a focus on the rehabilitation management of LBP. The objectives of the workshop are 1) to acquire knowledge about the recommendations from the most recent and high-quality CPGs for the management of LBP and 2) to foster their integration into clinical practice. An interactive workshop will be conducted to present the results of the review of the literature with the help of case-studies to facilitate implementation and promote active participation.

Primary outcome measure

  • Number of participants recruited for the study [ Time Frame: up to nine months. ]
  • Retention rate of participants [ Time Frame: T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians) ]
  • Suitability of admissibility criteria [ Time Frame: T2 (through study completion, up to nine months) ]
  • Clinicians' compliance to study protocol/fidelity of intervention [ Time Frame: T2 (through study completion, approximately nine months) ]

Central Contacts and Locations

Central contacts

Locations

Université de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 28, 2021

Last verified

May, 2021

Keywords

  • Pain management
  • Rehabilitation
  • Low back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2021-05-28.