Mechanical Low Back PainNCT03949179
Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model
An observational study of Mechanical Low Back Pain, run by Université de Sherbrooke at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- The Low Back Pain and Disability Drivers Management (PDDM) model
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 2 sitesCanada
- Study dates
- 3 May 2019to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients: * Patients presenting with non-specific LBP according to the assessment conducted by the PT
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Réseau de clinique PhysioExtra
Montreal, Quebec, H2B 1J9
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5H3
About this study
Official title: Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial
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.
Read the 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
- Mechanical Low Back Pain
- Being tested
- The Low Back Pain and Disability Drivers Management (PDDM) model
- Keywords
- Low back pain, Pain management, Rehabilitation, Feasibility outcomes
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Low Back Pain and Disability Drivers Management (PDDM) modelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Low Back Pain and Disability Drivers Management (PDDM) model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementation
Recruitment rate: % of eligible clinicians who enrolled in the study (T1)
Measured: T1: clinician's baseline.
Feasibility of implementation
Retention rate: % of contacted clinicians who accepted to participate and report data (T3-T1)
Measured: T1: clinician's baseline; T3 (6 weeks)
Clinician's acceptability of the workshop
Assessed via semi-structured phone interviews. It includes the clinician's appreciation of the training.
Measured: T1: clinician's baseline (after the workshop)
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.
Measured: T3 (6 weeks)
Secondary outcomes (5)
Nociceptive pain drivers : Change in Brief Pain Inventory (BPI) scores at 6 weeks
Change in BPI scores measured at T2 and T3 (T3-T2)
Measured: At T2: patient initial visit; T3: +6 weeks after initial visit
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)
Measured: At T2: patient initial visit; T3: +6 weeks after initial visit
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)
Measured: At T2: patient initial visit; T3: +6 weeks after initial visit
Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks
Change in SBT scores measured at T2 and T3 (T3-T2)
Measured: At T2: patient initial visit; T3: +6 weeks after initial visit
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)
Measured: At T2: patient initial visit; T3: +6 weeks after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start3 May 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Pain Research Network
- Responsible party
- Sponsor
- Investigators
- Yannick Tousignant-Laflamme, PhD, Principal investigator, School of Rehabilitation, University of Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949179
- Sponsor's protocol ID
- MP-31-2019-3131
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33471827
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial
- ClinicalTrials.gov ID
- NCT03949179
- Acronym / sponsor ID
- MP-31-2019-3131
- Conditions
- Mechanical Low Back Pain
- Keywords
- Low back pain, Pain management, Rehabilitation, Feasibility outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Quebec Pain Research Network
- Study start
- 3 May 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain and Disability Drivers Management model | – | Device: The Low Back Pain and Disability Drivers Management (PDDM) modelParticipating clinicians will use the PDDM model to guide assessment and treatment of their patients for a 6-weeks period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients: * Patients presenting with non-specific LBP according to the assessment conducted by the PT
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Low Back Pain and Disability Drivers Management (PDDM) modelThe 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. | Device | Pain and Disability Drivers Management model |
Primary outcome
Feasibility of implementation
Time frame: T1: clinician's baseline.
Recruitment rate: % of eligible clinicians who enrolled in the study (T1)
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)
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.
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.
5 secondary outcomes
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
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
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
Cognitive-emotional drivers: Change in StartBackTool (SBT) scores at 6 weeks
Time frame: At T2: patient initial visit; T3: +6 weeks after initial visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 33471827Longtin 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.
- Website (online resource) linked to the study that will be available to the participating clinicians in order to facilitate their use of the PDDM modelLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mechanical Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
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Fusion or Not - a Study on Low Back Pain
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Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
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Adia Med of Winter Park LLC Lower Back Pain Research Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Tousignant-Laflamme, PhD principal investigator
School of Rehabilitation, University of Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Low Back Pain, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementation (time frame: T1: clinician's baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.