Non Specific Low Back PainLOMBAFASTNCT05261828
Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
A study testing Education and rehabilitation associated with personalized follow-up and Reassuring messages and advices in people with Non Specific Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- Education and rehabilitation associated with personalized follow-up and Reassuring messages and advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2023to 10 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with subacute or chronic nonspecific low back pain (current episode duration ≥ 6 weeks), resistant to outpatient management, and including patients with radiculopathy as long as low back pain is predominant over pain in the lower extremity.
- Patients with less than 30 days off work (declarative) for low back pain in the previous year and involved in a professional activity at the time of inclusion.
- Patients manifesting fears and false beliefs and/or dramatization: to be included, the patient will have to answer yes to one of the following two questions:
- Are you afraid to move?
- Are you afraid you will never get out of it?
- Patients eligible for a rehabilitation exercise program
- informed and written consent to participate
Who cannot join
- Age < 18 years,
- Insufficient French language proficiency.
- Patients having followed a multidisciplinary rehabilitation program for their low back pain in the 3 months preceding inclusion.
- Patients who have had lumbar spine surgery within the last 12 months.
- Pregnancy in progress.
- No affiliation with a health insurance program.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are:
- to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability,
- to estimate the cost-utility ratio of the intervention.
Read the detailed description
Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Subacute LBP is commonly defined as back pain lasting between 6 weeks and 3 months, chronic LBP as pain that persists for 3 or more months. In its most severe forms, subacute and chronic LBP can lead to severe disability that combines physical and psychological deconditioning, limitations in basic and complex activities of daily living, professional exclusion and social marginalization.
The direct and indirect medical and economic cost of chronic LBP is major for society.
Since the eighties, the bio-psycho-social approach has emerged for the treatment of people with chronic LBP and has led to multidisciplinary functional restoration (FR) programs that include physical activity, exercises, education, occupational therapy and psychological and social rehabilitation. However, the efficiency of these programs is inconsistent and their cost-effectiveness is criticized.
As FR programs are by definition standardized, the treatment of chronic LBP remains poorly stratified. However, interest in stratified therapeutic strategies has recently emerged and shown promising results. To date, in France, only semi-intensive (<100h) or intensive (>100h) FR programs dedicated to severely disabled patients with chronic LBP have been assessed The investigators' main hypothesis is that an intervention consisting in a short multidisciplinary program including education and rehabilitation and a personalized follow-up could reduce the activity limitations of not severely disabled patients with subacute and chronic LBP.
The investigators' secondary hypothesis is that such an intervention could also reduce the main risk factors for evolution of patients with LBP towards a severe disability.
- Conditions
- Non Specific Low Back Pain
- Being tested
- Education and rehabilitation associated with personalized follow-up, Reassuring messages and advices
- Keywords
- low back pain, activity limitations, disability, rehabilitation, physiotherapy, exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and rehabilitation associated with personalized follow-upBehavioural
short multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain
Reassuring messages and advicesBehavioural
Reassuring messages and advices in agreement with current recommendations
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Short multidisciplinary program including education and rehabilitation and a personalized follow-up program Receives: Behavioral: Education and rehabilitation associated with personalized follow-up |
| B | Active comparator | Reassuring messages and advices in agreement with the current recommendations. Receives: Behavioral: Reassuring messages and advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
low back pain activity limitation
Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)
Measured: 3 months
Secondary outcomes (7)
low back pain activity limitation
Variation in the level of low back pain activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)
Measured: 6 and 12 months.
fears and beliefs about work
Variation in the level of fears and beliefs about work assessed by the work sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (0, no fears and beliefs and 24, maximum fears and beliefs)
Measured: 3 months
fears and beliefs about physical activity
Variation in the level of fears and beliefs about physical activity assessed by the physical activity sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (FABQ), (0, no fears and beliefs and 42, maximum fears and beliefs)
Measured: 3 months
days off work
Number of "days off work" reported by the patient
Measured: 3 and 12 months
low back pain
Variation in the mean intensity of low back pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)
Measured: 3 months
radicular pain
Change in mean intensity of radicular pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)
Measured: 3 months
cost-utility ratio
Incremental cost-utility ratio
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 posted2 Mar 2022
- Study start14 Feb 2023
- Primary completion4 Feb 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandra ROREN, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261828
- Sponsor's protocol ID
- APHP200142
- Other IDs
- 2020-A02601-38
- Acronym
- LOMBAFAST
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2022
- Last updated
- 1 Dec 2025
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
- ClinicalTrials.gov ID
- NCT05261828
- Acronym / sponsor ID
- LOMBAFAST / APHP200142
- Conditions
- Non Specific Low Back Pain
- Keywords
- low back pain, activity limitations, disability, rehabilitation, physiotherapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 2 Mar 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.
The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are:
- to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability,
- to estimate the cost-utility ratio of the intervention.
Detailed description
Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Subacute LBP is commonly defined as back pain lasting between 6 weeks and 3 months, chronic LBP as pain that persists for 3 or more months. In its most severe forms, subacute and chronic LBP can lead to severe disability that combines physical and psychological deconditioning, limitations in basic and complex activities of daily living, professional exclusion and social marginalization.
The direct and indirect medical and economic cost of chronic LBP is major for society.
Since the eighties, the bio-psycho-social approach has emerged for the treatment of people with chronic LBP and has led to multidisciplinary functional restoration (FR) programs that include physical activity, exercises, education, occupational therapy and psychological and social rehabilitation. However, the efficiency of these programs is inconsistent and their cost-effectiveness is criticized.
As FR programs are by definition standardized, the treatment of chronic LBP remains poorly stratified. However, interest in stratified therapeutic strategies has recently emerged and shown promising results. To date, in France, only semi-intensive (<100h) or intensive (>100h) FR programs dedicated to severely disabled patients with chronic LBP have been assessed The investigators' main hypothesis is that an intervention consisting in a short multidisciplinary program including education and rehabilitation and a personalized follow-up could reduce the activity limitations of not severely disabled patients with subacute and chronic LBP.
The investigators' secondary hypothesis is that such an intervention could also reduce the main risk factors for evolution of patients with LBP towards a severe disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Education and rehabilitation associated with personalized follow-upShort multidisciplinary program including education and rehabilitation and a personalized follow-up program |
| B | Active comparator | Behavioral: Reassuring messages and advicesReassuring messages and advices in agreement with the current recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with subacute or chronic nonspecific low back pain (current episode duration ≥ 6 weeks), resistant to outpatient management, and including patients with radiculopathy as long as low back pain is predominant over pain in the lower extremity.
- Patients with less than 30 days off work (declarative) for low back pain in the previous year and involved in a professional activity at the time of inclusion.
- Patients manifesting fears and false beliefs and/or dramatization: to be included, the patient will have to answer yes to one of the following two questions:
- Patients eligible for a rehabilitation exercise program
- informed and written consent to participate
Key exclusion criteria (6 listed)
- Age < 18 years,
- Insufficient French language proficiency.
- Patients having followed a multidisciplinary rehabilitation program for their low back pain in the 3 months preceding inclusion.
- Patients who have had lumbar spine surgery within the last 12 months.
- Pregnancy in progress.
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 |
|---|---|---|
| Education and rehabilitation associated with personalized follow-upshort multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain | Behavioural | A |
| Reassuring messages and advicesReassuring messages and advices in agreement with current recommendations | Behavioural | B |
Primary outcome
low back pain activity limitation
Time frame: 3 months
Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)
7 secondary outcomes
low back pain activity limitation
Time frame: 6 and 12 months.
fears and beliefs about work
Time frame: 3 months
fears and beliefs about physical activity
Time frame: 3 months
days off work
Time frame: 3 and 12 months
low back pain
Time frame: 3 months
radicular pain
Time frame: 3 months
cost-utility ratio
Time frame: 12 months
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 1 Dec 2025.
- 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.
Alexandra ROREN, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and rehabilitation associated with personalized follow-up and Reassuring messages and advices in people with Non Specific Low Back Pain, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 6 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 1 Dec 2025. 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?
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?
low back pain activity limitation (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 1 Dec 2025.