Subacute or Chronic Low Back PainLC-ONENCT04133818
Feasibility of a One-day-and-a-half for Patients With Low Back Pain
An observational study of Subacute or Chronic Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute or Chronic Low Back Pain
- What is being tested?
- Multidisciplinary education and exercise therapy program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 30 Sep 2019
- Phase
- Observational
- 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
Study population: Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated and who had benefited in PMR unit of Cochin' hospital of a no intensive multidisciplinary rehabilitation program.
Who may be able to join
- age ≥ 18 years
- subacute or chronic non-specific LBP ≥ 6 weeks
- no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP
- currently working
- written consent
Who cannot join
- inability to speak or read French
- cognitive impairment
- current sick leave
- history of intensive multidisciplinary rehabilitation program for LBP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study
The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.
Read the detailed description
Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.
This no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.
It is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.
Data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.
- Conditions
- Subacute or Chronic Low Back Pain
- Being tested
- Multidisciplinary education and exercise therapy program
- Keywords
- Multidisciplinary education and exercise therapy program., Physical activity, Rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary education and exercise therapy programBehavioural
Multidisciplinary program: one and a half day of education and exercise therapy about low back pain :
- Lectures and explanations about low back pain
- Physical activity
- Relaxation
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary program. | Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated. Receives: Behavioral: Multidisciplinary education and exercise therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability)
Measured: 3 months
Secondary outcomes (2)
Efficiency
Efficiency of the program to diminish pain (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the most important pain and 0 no pain at all)
Measured: 3 months
Efficiency
Efficiency of the program to diminish fear and beliefs (FABQ, between 0 and 66 with 66 representing the highest level of fear and beliefs about low back pain and 0 representing no fear and beliefs about low back pain)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Jul 2017
- Primary completion1 Apr 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacute or Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 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
- Christelle NGUYEN, MD, PhD, Principal investigator, APHP (Assistance Publique-Hôpitaux de Paris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133818
- Sponsor's protocol ID
- LC-ONE
- Other IDs
- APHP190887
- Acronym
- LC-ONE
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
PubMed 19204216Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.
PubMed 29229056Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. doi: 10.1016/j.spinee.2007.07.389. Epub 2007 Nov 19.
PubMed 18024224Garofoli R, Boisson M, Segretin F, Linieres J, Gerard C, Moreau S, Ieong E, Chagny F, Bedin C, Lefevre-Colau MM, Rannou F, Roren A, Nguyen C. Feasibility of a short multidisciplinary education and exercise therapy program for patients with non-specific low back pain: A 3-month retrospective open pilot study. Ann Phys Rehabil Med. 2019 Sep;62(5):382-385. doi: 10.1016/j.rehab.2019.05.005. Epub 2019 May 31. No abstract available.
PubMed 31158552
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study
- ClinicalTrials.gov ID
- NCT04133818
- Acronym / sponsor ID
- LC-ONE / LC-ONE
- Conditions
- Subacute or Chronic Low Back Pain
- Keywords
- Multidisciplinary education and exercise therapy program., Physical activity, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Oct 2019 (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 purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.
Detailed description
Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.
This no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.
It is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.
Data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary program. | – | Behavioral: Multidisciplinary education and exercise therapy programPatients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated and who had benefited in PMR unit of Cochin' hospital of a no intensive multidisciplinary rehabilitation program.
Key inclusion criteria (5 listed)
- age ≥ 18 years
- subacute or chronic non-specific LBP ≥ 6 weeks
- no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP
- currently working
- written consent
Key exclusion criteria (4 listed)
- inability to speak or read French
- cognitive impairment
- current sick leave
- history of intensive multidisciplinary rehabilitation program for LBP
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 |
|---|---|---|
| Multidisciplinary education and exercise therapy programMultidisciplinary program: one and a half day of education and exercise therapy about low back pain : * Lectures and explanations about low back pain * Physical activity * Relaxation | Behavioural | Multidisciplinary program. |
Primary outcome
Acceptability
Time frame: 3 months
Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability)
2 secondary outcomes
Efficiency
Time frame: 3 months
Efficiency
Time frame: 3 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 12 Sep 2025.
- Background: PubMed 19204216Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
- Background: PubMed 29229056Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.
- Background: PubMed 18024224Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. doi: 10.1016/j.spinee.2007.07.389. Epub 2007 Nov 19.
- Results publication: PubMed 31158552Garofoli R, Boisson M, Segretin F, Linieres J, Gerard C, Moreau S, Ieong E, Chagny F, Bedin C, Lefevre-Colau MM, Rannou F, Roren A, Nguyen C. Feasibility of a short multidisciplinary education and exercise therapy program for patients with non-specific low back pain: A 3-month retrospective open pilot study. Ann Phys Rehabil Med. 2019 Sep;62(5):382-385. doi: 10.1016/j.rehab.2019.05.005. Epub 2019 May 31. No abstract available.
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.
Christelle NGUYEN, MD, PhD principal investigator
APHP (Assistance Publique-Hôpitaux de Paris)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacute or Chronic 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 5 inclusion and 4 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 12 Sep 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?
Acceptability (time frame: 3 months). 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 NCT04133818, which also lists 4 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 12 Sep 2025.