Low Back PainEFFIBACKNCT05531201
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
A study testing collaboration general practitioner and physiotherapist in people with Low Back Pain, run by CNGE Conseil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- collaboration general practitioner and physiotherapist
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 13 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Maison de Santé Pluriprofessionnelle Universitaire
Fontainebleau, 77300
About this study
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
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.
- Conditions
- Low Back Pain
- Being tested
- collaboration general practitioner and 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.
collaboration general practitioner and physiotherapistProcedure or surgery
training general practitioner and physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Trainig of GP and physiotherapist at collaborative coordinated care pathway Receives: Procedure: collaboration general practitioner and physiotherapist |
| Control | No intervention | without modification of the usual follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (8)
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).
Measured: 12 months
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
Measured: 3 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
Measured: 12 months
Evaluation of the course of care: compliance
number (%) of patients having followed the entire course of care
Measured: 12 months
Evaluation of the course of care: number of consultations
total number of consultations with GPs and physiotherapists (PTs)
Measured: 12 months
Evaluation of the course of care: medical imaging
total number of medical imaging related to low back during the follow up
Measured: 12 months
Evaluation of the course of care: total cost
total cost (in euros €) of healthcare pathway in the two groups
Measured: 12 months
Evaluation of effective collaborative practices
qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start15 Feb 2023
- Primary completion20 Jan 2026
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNGE Conseil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tan-Trung PHAN, Study chair, Département Universitaire d'Enseignement et de Recherche en Médecine Générale - Université Paris-Est Créteil, 8 rue du Général Sarrail 94010 Créteil Cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531201
- Sponsor's protocol ID
- CNGE-2021/01
- Other IDs
- 2021-A02432-39
- Acronym
- EFFIBACK
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05531201
- Acronym / sponsor ID
- EFFIBACK / CNGE-2021/01
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- CNGE ConseilUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 7 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: collaboration general practitioner and physiotherapistTrainig of GP and physiotherapist at collaborative coordinated care pathway |
| Control | No intervention | –without modification of the usual follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| collaboration general practitioner and physiotherapisttraining general practitioner and physiotherapist | Procedure or surgery | Interventional |
Primary outcome
Disability at 3 months
Time frame: 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).
8 secondary outcomes
Disability at 12 months
Time frame: 12 months
Health-related quality of life at 3 months
Time frame: 3 months
Health-related quality of life at 12 months
Time frame: 12 months
Evaluation of the course of care: compliance
Time frame: 12 months
Evaluation of the course of care: number of consultations
Time frame: 12 months
Evaluation of the course of care: medical imaging
Time frame: 12 months
Evaluation of the course of care: total cost
Time frame: 12 months
Evaluation of effective collaborative practices
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Tan-Trung PHAN study chair
Département Universitaire d'Enseignement et de Recherche en Médecine Générale - Université Paris-Est Créteil, 8 rue du Général Sarrail 94010 Créteil Cedex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collaboration general practitioner and physiotherapist in people with Low Back Pain, run by CNGE Conseil at 1 site 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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Disability at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.