## Protocol Section
### Identification Module
**NCT ID:** NCT03949179

**Brief Title:** Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model

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

#### Organization Study ID Info
**ID:** MP-31-2019-3131
#### Organization
**Class:** OTHER
**Full Name:** Université de Sherbrooke
### Status Module
#### Completion Date
**Date:** 2019-12-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-24

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-15

**Type:** ACTUAL

#### Start Date
**Date:** 2019-05-03

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2019-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-29
**Study First Submit QC Date:** 2019-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Quebec Pain Research Network

#### Lead Sponsor

**Class:** OTHER

**Name:** Université de Sherbrooke

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Mechanical Low Back Pain

**Keywords:**

- Low back pain

- Pain management

- Rehabilitation

- Feasibility outcomes

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 86

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participating clinicians will use the PDDM model to guide assessment and treatment of their patients for a 6-weeks period.

**Intervention Names:**

- Device: The Low Back Pain and Disability Drivers Management (PDDM) model

**Label:** Pain and Disability Drivers Management model

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pain and Disability Drivers Management model

**Description:** 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.

**Name:** The Low Back Pain and Disability Drivers Management (PDDM) model

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Feasibility of implementation

**Time Frame:** T1: clinician's baseline.

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

**Measure:** Feasibility of implementation

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

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

**Measure:** Clinician's acceptability of the workshop

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

**Description:** 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.

**Measure:** Clinician's acceptability of the intervention

**Time Frame:** T3 (6 weeks)

#### Secondary Outcomes

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

**Measure:** 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

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

**Measure:** 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

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

**Measure:** 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

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

**Measure:** Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks

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

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

**Measure:** 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

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients:

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montréal

**Country:** Canada

**Facility:** Réseau de clinique PhysioExtra

**State:** Quebec

**Zip:** H2B 1J9

**Location 2:**

**City:** Sherbrooke

**Country:** Canada

**Facility:** CIUSSS de l'Estrie - CHUS

**State:** Quebec

**Zip:** J1H 5H3

#### Overall Officials

**Official 1:**

**Affiliation:** School of Rehabilitation, University of Sherbrooke

**Name:** Yannick Tousignant-Laflamme, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Longtin C, Decary S, Cook CE, Martel MO, Lafrenaye S, Carlesso LC, Naye F, Tousignant-Laflamme Y. Optimizing management of low back pain through the pain and disability drivers management model: A feasibility trial. PLoS One. 2021 Jan 20;16(1):e0245689. doi: 10.1371/journal.pone.0245689. eCollection 2021.

**PMID:** 33471827

#### See Also Links

**Label:** 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

**URL:** https://pddmmodel.wordpress.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-24
