Determining the Effectiveness of the Pain and Disability Drivers Management Model on the Management of Low Back Pain

NCT04893369 | Unknown DMC

• 1 other identifier: 2021-3524
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Pain management; Rehabilitation; Low back pain

Outcome Measures

Primary Outcomes (4)

• Number of participants recruited for the study

  Overall recruitment of participants during the nine months recruitment period. Recruitment rate defined as % of eligible clinicians who enrolled in the study for each clinic. Clinician/patient recruitment ratio.

  up to nine months.

• Retention rate of participants

  Measured by attrition rate of the participants : % of patients enrolled in the study but who did not complete the study (e.g., questionnaires, dropped out, lost to follow-up)

  T2 (12 weeks post enrollment for patients and through study completion, up to nine months for clinicians)

• Suitability of admissibility criteria

  Determined based on overall recruitment rate and clinicians' answers to two questions at the end of the study (T2): are the criteria sufficient or too restrictive? Is it obvious who meets and who does not meet the eligibility criteria

  T2 (through study completion, up to nine months)

• Clinicians' compliance to study protocol/fidelity of intervention

  Assessment of clinician's compliance to the study protocol will include (yes/no): 1) completion of the knowledge and skills assessment following the workshop, and 2) the reporting of five patients' clinical data by the PT according to the PDDM model or CPGs following their initial assessment at baseline (T0).

  T2 (through study completion, approximately nine months)

Secondary Outcomes (7)

• Change from baseline in severity and impact of pain on function at 12 weeks

  Change in BPI scores at 0, 6 and 12 weeks.

• Change from baseline in nervous system dysfunctions at 12 weeks

  Change in PAINdetect scores at 0, 6 and 12 weeks.

• Change from baseline in nervous system dysfunctions at 12 weeks

  Change in CSI-9 scores at 0, 6 and 12 weeks.

• Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks

  Change in FABQ-physical activity scores at 0, 6 and 12 weeks.

• Change from baseline in cognitive-affective drivers of pain and disability at 12 weeks

  Change in CPSS scores at 0, 6 and 12 weeks.

Study Arms (2)

The Low Back Pain and Disability Drivers Management model

EXPERIMENTAL

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.

Other: The Low Back Pain and Disability Drivers Management model

Low back pain clinical practice guidelines

ACTIVE COMPARATOR

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.

Other: Low back pain clinical practice guidelines

Interventions

The Low Back Pain and Disability Drivers Management model OTHER

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.

The Low Back Pain and Disability Drivers Management model

Low back pain clinical practice guidelines OTHER

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.

Low back pain clinical practice guidelines

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• For the control group, clinicians will be excluded if they have already attended a workshop on the PDDM model
• Patients' eligibility 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
• Patients not deemed fit for rehabilitation by their therapist (i.e., red flags)
• Patients already undergoing physiotherapy treatment for their episode of LBP

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Publications (2)

• Longtin C, Lacasse A, Cook CE, Tousignant M, Tousignant-Laflamme Y. Management of low back pain by primary care physiotherapists using the pain and disability drivers management model: An improver analysis. Musculoskeletal Care. 2023 Sep;21(3):916-925. doi: 10.1002/msc.1742. Epub 2023 Feb 10. No abstract available.

  PMID: 36762893 DERIVED

• Longtin C, Decary S, Cook CE, Tousignant M, Lacasse A, Tousignant-Laflamme Y. Optimising management of low back pain through the pain and disability drivers management model: Findings from a pilot cluster nonrandomised controlled trial. Musculoskeletal Care. 2023 Sep;21(3):667-682. doi: 10.1002/msc.1738. Epub 2023 Feb 7.

  PMID: 36749025 DERIVED

Related Links

• Description: 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Yannick Tousignant-Laflamme, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Michel Tousignant, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Longtin, MSc

CONTACT

1 819 821-8000; christian.longtin@usherbrooke.ca

Yannick Tousignant-Laflamme, PhD

CONTACT

1 819 821-8000; yannick.tousignant-laflamme@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participating patients will be blinded to their therapist's allocation. Outcomes assessor will be blinded to the participants' allocation since data will be coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm nonrandomized pragmatic cluster clinical trial

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: May 4, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)