Low Back PainLombalgIPNCT05200533
Task-sharing and Shifting Model for Acute Low Back Pain
A study testing Task-sharing and shifting model between family physicians and physiotherapists in people with Low Back Pain, run by University Hospital, Grenoble at 6 sites in France.
Trial summary
Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Task-sharing and shifting model between family physicians and physiotherapists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Mar 2022to 31 Jan 2024
- Phase
- Interventional
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from 20 to 55 years old
- Suffering from acute low back pain since less than 4 weeks
- Able to understand and speak French
- Whose family physician is included in the task-sharing and shifting model (only in the intervention group)
Who cannot join
- Protected patient according to the public health regulation,
- Patient unable to fill the survey,
- Non-availability of the physiotherapist to receive the patient (only in the intervention group)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Maison de santé pluriprofessionnelle de Cran Gévrier
Annecy, Auvergne-Rhône-Alpes, 74960
Céline Tuttino, medicran74@gmail.com
Bruno Mas
- Recruiting
Maison de santé pluriprofessionnelle des Hauts de Chambéry
Chambéry, Auvergne-Rhône-Alpes, 73000
Emilie Fuentes, emilie.f@recoords.fr
Guillaume Bouchet, Dr
- Recruiting
Maison de santé pluriprofessionnelle de Voiron-Sud
Coublevie, Auvergne-Rhône-Alpes, 38500
Sabine Pages, sabine.pages@free.fr
Patrick Lambert, Dr
- Recruiting
Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors
Lans-en-Vercors, Auvergne-Rhône-Alpes, 38250
Laetitia Wrona, assistanteencoordination@gmail.com
Alban Thoret
- Recruiting
Maison de santé pluriprofessionnelle de Moirans
Moirans, Auvergne-Rhône-Alpes, 38430
Sabine Pages, sabine.pages@free.fr
Muriel Carlotti, Dr
- Recruiting
Pôle de santé interprofessionnel de Saint-Martin d'Hères
Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, 38400
Maxime Bertolini, maxime.bertolini@psip-smh.fr
Laura Vasselier
About this study
Official title: Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial
Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.
Design: Pragmatic cluster randomized controlled trial
- Conditions
- Low Back Pain
- Being tested
- Task-sharing and shifting model between family physicians and physiotherapists, Usual care
- Keywords
- Task-sharing, Task-shifting, Family physician, Physiotherapist
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-sharing and shifting model between family physicians and physiotherapistsOther
Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.
Usual careOther
Medical consultations for acute low back pain patients are performed by family physicians
| Study group | Role | What they receive |
|---|---|---|
| Task-sharing and shifting | Experimental | In the task-sharing and shifting group, family physicians shifted acute low back pain consultations to physiotherapists. Patients with acute low back pain are seen by the physiotherapist instead of family physician. Physiotherapist diagnose acute low back pain, identify red and yellow flags, prescribe sick leave and medications and can refer the patient to additional physical therapy treatment. Receives: Other: Task-sharing and shifting model between family physicians and physiotherapists |
| Usual care | Active comparator | In the usual care group, patients with acute low back pain are seen by their family physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks
Rolland Morris Disability Questionnaire It is a 24 points scale. The lower score is 0, the higher score is 24. Higher scores mean worse outcomes as the disability level is higher.
Measured: 6 weeks after the initial consultation
Secondary outcomes (6)
Effect of the TS/S model on acute LBP patients' disability at 3 months
Rolland Morris Disability Questionnaire It is a 24 points scale. Scores rank form 0 to 24. Higher scores mean worse outcomes as the disability level is higher.
Measured: 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
Brief Pain Inventory It is a 10 points scale. Scores rank from 0 to 10. Higher scores mean worse outcomes, as the pain level is higher.
Measured: 6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months
Start-Back screening tool It is a 9 points scale. Scores rank from 0 to 9. Higher scores mean worse outcomes.
Measured: 6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's satisfaction
Medrisk questionnaire It is a 5 points scale. Scores rank from 0 to 5. Higher scores mean better outcomes;
Measured: Few minutes after the initial consultation (less than one hour)
Effect of the TS/S model on acute LBP patient's wait time before the initial consultation
Time (number of days and hours)
Measured: Initial consultation
Effect of the TS/S model on healthcare resources use
Initial prescription of sick leave and medications, number of family physician visits, number of physical therapy appointments, number of emergency department visits at 6 weeks and 3 months
Measured: Initial consultation, 6 weeks and 3 months after the initial consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Mar 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG
- Responsible party
- Sponsor
- Investigators
- Nicolas Pinsault, PhD, Study director, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200533
- Sponsor's protocol ID
- 38RC21.0259
- Acronym
- LombalgIP
- Status last verified
- Jun 2023
- First submitted
- 6 Jan 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020.
PubMed 32628696Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.
PubMed 31603709Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.
PubMed 27081203Desmeules F, Roy JS, MacDermid JC, Champagne F, Hinse O, Woodhouse LJ. Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review. BMC Musculoskelet Disord. 2012 Jun 21;13:107. doi: 10.1186/1471-2474-13-107.
PubMed 22716771Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.
PubMed 21963002Kechichian A, Lafrance S, Matifat E, Dube F, Lussier D, Benhaim P, Perreault K, Filiatrault J, Rainville P, Higgins J, Rousseau J, Masse J, Desmeules F. Multimodal Interventions Including Rehabilitation Exercise for Older Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-analyses of Randomized Controlled Trials. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):34-49. doi: 10.1519/JPT.0000000000000279.
PubMed 34928239Kechichian A, Desmeules F, Girard P, Terrisse H, Vermorel C, Pinsault N. Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial. BMC Health Serv Res. 2024 Nov 18;24(1):1427. doi: 10.1186/s12913-024-11814-2.
PubMed 39558330
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05200533
- Acronym / sponsor ID
- LombalgIP / 38RC21.0259
- Conditions
- Low Back Pain
- Keywords
- Task-sharing, Task-shifting, Family physician, Physiotherapist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 20 Jan 2022 (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.
Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.
Design: Pragmatic cluster randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Task-sharing and shifting | Experimental | Other: Task-sharing and shifting model between family physicians and physiotherapistsIn the task-sharing and shifting group, family physicians shifted acute low back pain consultations to physiotherapists. Patients with acute low back pain are seen by the physiotherapist instead of family physician. Physiotherapist diagnose acute low back pain, identify red and yellow flags, prescribe sick leave and medications and can refer the patient to additional physical therapy treatment. |
| Usual care | Active comparator | Other: Usual careIn the usual care group, patients with acute low back pain are seen by their family physician. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients from 20 to 55 years old
- Suffering from acute low back pain since less than 4 weeks
- Able to understand and speak French
- Whose family physician is included in the task-sharing and shifting model (only in the intervention group)
Key exclusion criteria (3 listed)
- Protected patient according to the public health regulation,
- Patient unable to fill the survey,
- Non-availability of the physiotherapist to receive the patient (only in the intervention group)
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 |
|---|---|---|
| Task-sharing and shifting model between family physicians and physiotherapistsMedical consultations for acute low back pain patients are shifted from family physicians to physiotherapists. | Other | Task-sharing and shifting |
| Usual careMedical consultations for acute low back pain patients are performed by family physicians | Other | Usual care |
Primary outcome
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks
Time frame: 6 weeks after the initial consultation
Rolland Morris Disability Questionnaire It is a 24 points scale. The lower score is 0, the higher score is 24. Higher scores mean worse outcomes as the disability level is higher.
6 secondary outcomes
Effect of the TS/S model on acute LBP patients' disability at 3 months
Time frame: 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
Time frame: 6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months
Time frame: 6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's satisfaction
Time frame: Few minutes after the initial consultation (less than one hour)
Effect of the TS/S model on acute LBP patient's wait time before the initial consultation
Time frame: Initial consultation
Effect of the TS/S model on healthcare resources use
Time frame: Initial consultation, 6 weeks and 3 months after the initial consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 32628696Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020.
- Background: PubMed 31603709Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.
- Background: PubMed 27081203Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.
- Background: PubMed 22716771Desmeules F, Roy JS, MacDermid JC, Champagne F, Hinse O, Woodhouse LJ. Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review. BMC Musculoskelet Disord. 2012 Jun 21;13:107. doi: 10.1186/1471-2474-13-107.
- Background: PubMed 21963002Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.
- Background: PubMed 34928239Kechichian A, Lafrance S, Matifat E, Dube F, Lussier D, Benhaim P, Perreault K, Filiatrault J, Rainville P, Higgins J, Rousseau J, Masse J, Desmeules F. Multimodal Interventions Including Rehabilitation Exercise for Older Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-analyses of Randomized Controlled Trials. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):34-49. doi: 10.1519/JPT.0000000000000279.
- Derived from this study: PubMed 39558330Kechichian A, Desmeules F, Girard P, Terrisse H, Vermorel C, Pinsault N. Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial. BMC Health Serv Res. 2024 Nov 18;24(1):1427. doi: 10.1186/s12913-024-11814-2.
- Individual participant dataSharing planned: No
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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.
Nicolas Pinsault, PhD study director
University Grenoble Alps
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-sharing and shifting model between family physicians and physiotherapists in people with Low Back Pain, run by University Hospital, Grenoble at 6 sites in France.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amelie Kechichian, PhD student (+33 (0)698304997, akechichian@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks (time frame: 6 weeks after the initial consultation). 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 NCT05200533, which also lists 7 linked publications.
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 27 Jun 2023.