Back to resultsEvaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care (EFFIBACK)
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collaboration general practitioner and physiotherapist
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
Adult patients between the ages of 18 and 65
- Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than 3.
- OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
- OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
- OR having chronic low back pain (low back pain for more than 3 months)
- Patients benefiting from the general social security system
- Patients who understand and speak French fluently
- Patients who have given their consent after having received complete information on the protocol
Exclusion Criteria:
- Minor patients
- Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
- Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
- Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
- Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
- Patients with a contraindication to rehabilitation by physiotherapy
- Patients who have already undergone spine surgery
- Patients with cognitive impairment
- Patients whose life expectancy is less than 12 months
- Patients under guardianship or curatorship, under judicial protection or safeguard of justice
- Patients not affiliated to the general social security system
- Patients with difficulties in understanding the French language
- Patients with an inability to give express consent
Sites / Locations
- Maison de Santé Pluriprofessionnelle UniversitaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional
Control
Arm Description
Trainig of GP and physiotherapist at collaborative coordinated care pathway
without modification of the usual follow-up
Outcomes
Primary Outcome Measures
Disability at 3 months
Absolute change in overall Oswestry Disability Index (ODI) scale score between 0 and 3 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
Secondary Outcome Measures
Disability at 12 months
Absolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
Health-related quality of life at 3 months
Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 3 months and between 0 and 12 months
Health-related quality of life at 12 months
Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months
Evaluation of the course of care: compliance
number (%) of patients having followed the entire course of care
Evaluation of the course of care: number of consultations
total number of consultations with GPs and physiotherapists (PTs)
Evaluation of the course of care: medical imaging
total number of medical imaging related to low back during the follow up
Evaluation of the course of care: total cost
total cost (in euros €) of healthcare pathway in the two groups
Evaluation of effective collaborative practices
qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05531201
Brief Title
Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care
Acronym
EFFIBACK
Official Title
Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic Low Back Pain and Patients at Risk of Chronic Low Back Pain in Primary Care: a Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
February 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CNGE Conseil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Trainig of GP and physiotherapist at collaborative coordinated care pathway
Arm Title
Control
Arm Type
No Intervention
Arm Description
without modification of the usual follow-up
Intervention Type
Procedure
Intervention Name(s)
collaboration general practitioner and physiotherapist
Intervention Description
training general practitioner and physiotherapist
Primary Outcome Measure Information:
Title
Disability at 3 months
Description
Absolute change in overall Oswestry Disability Index (ODI) scale score between 0 and 3 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disability at 12 months
Description
Absolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
Time Frame
12 months
Title
Health-related quality of life at 3 months
Description
Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 3 months and between 0 and 12 months
Time Frame
3 months
Title
Health-related quality of life at 12 months
Description
Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months
Time Frame
12 months
Title
Evaluation of the course of care: compliance
Description
number (%) of patients having followed the entire course of care
Time Frame
12 months
Title
Evaluation of the course of care: number of consultations
Description
total number of consultations with GPs and physiotherapists (PTs)
Time Frame
12 months
Title
Evaluation of the course of care: medical imaging
Description
total number of medical imaging related to low back during the follow up
Time Frame
12 months
Title
Evaluation of the course of care: total cost
Description
total cost (in euros €) of healthcare pathway in the two groups
Time Frame
12 months
Title
Evaluation of effective collaborative practices
Description
qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients between the ages of 18 and 65
Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than 3.
OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
OR having chronic low back pain (low back pain for more than 3 months)
Patients benefiting from the general social security system
Patients who understand and speak French fluently
Patients who have given their consent after having received complete information on the protocol
Exclusion Criteria:
Minor patients
Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
Patients with a contraindication to rehabilitation by physiotherapy
Patients who have already undergone spine surgery
Patients with cognitive impairment
Patients whose life expectancy is less than 12 months
Patients under guardianship or curatorship, under judicial protection or safeguard of justice
Patients not affiliated to the general social security system
Patients with difficulties in understanding the French language
Patients with an inability to give express consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan-Trung PHAN
Phone
01 85 48 12 34/06 63 48 53 81
Email
tan-trung.phan@u-pec.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien LE BRETON
Phone
06 64 00 91 07
Email
julien.le.breton@u-pec.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan-Trung PHAN
Organizational Affiliation
Département Universitaire d'Enseignement et de Recherche en Médecine Générale - Université Paris-Est Créteil, 8 rue du Général Sarrail 94010 Créteil Cedex
Official's Role
Study Chair
Facility Information:
Facility Name
Maison de Santé Pluriprofessionnelle Universitaire
City
Fontainebleau
ZIP/Postal Code
77300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan-Trung PHAN, Dr
Phone
01 85 48 12 34
Email
tantrungphan1@gmail.com
First Name & Middle Initial & Last Name & Degree
Tan-Trung PHAN, Dr
First Name & Middle Initial & Last Name & Degree
Bruchet BRUCHET, Dr
First Name & Middle Initial & Last Name & Degree
Monica NEAGOE, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care
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