Task-sharing and Shifting Model for Acute Low Back Pain

Low Back Pain Clinical Trial

— LombalgIP  

Official title:

Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200533
• Other study ID #: 38RC21.0259
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Grenoble
• Contact: Amelie Kechichian, PhD student
• Phone: +33 (0)698304997
• Email: akechichian[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: January 31, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Task-sharing and shifting model between family physicians and physiotherapists
Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.
• Usual care
Medical consultations for acute low back pain patients are performed by family physicians

Locations

Country	Name	City	State
France	Maison de santé pluriprofessionnelle de Cran Gévrier	Annecy	Auvergne-Rhône-Alpes
France	Maison de santé pluriprofessionnelle des Hauts de Chambéry	Chambéry	Auvergne-Rhône-Alpes
France	Maison de santé pluriprofessionnelle de Voiron-Sud	Coublevie	Auvergne-Rhône-Alpes
France	Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors	Lans-en-Vercors	Auvergne-Rhône-Alpes
France	Maison de santé pluriprofessionnelle de Moirans	Moirans	Auvergne-Rhône-Alpes
France	Pôle de santé interprofessionnel de Saint-Martin d'Hères	Saint-Martin-d'Hères	Auvergne-Rhône-Alpes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

Chiarotto 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. — View Citation

Demont 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. — View Citation

Desmeules 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. — View Citation

Hill 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. — View Citation

Kechichian 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks after the initial consultation
Secondary	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.	3 months after the initial consultation
Secondary	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.	6 weeks and 3 months after the initial consultation
Secondary	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.	6 weeks and 3 months after the initial consultation
Secondary	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;	Few minutes after the initial consultation (less than one hour)
Secondary	Effect of the TS/S model on acute LBP patient's wait time before the initial consultation	Time (number of days and hours)	Initial consultation
Secondary	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	Initial consultation, 6 weeks and 3 months after the initial consultation