Chronic Low-back PainFRELOMBNCT04128098
Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Evaluation, Questionnaires and Rehabilitation care program
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 23 Feb 2021
- 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: patient presenting for consultation in the re-education and rehabilitation department of the CHU Dijon Bourgogne
Who may be able to join
- Adult patient
- Having provided oral consent
- Chronic non-specific low back pain (HAS2015 criteria)
- Eligible for a rehabilitation program
- Patient affiliated or benefiting from a social security scheme
Who cannot join
- Adult unable to provide consent
- Lumbar spine surgery scheduled in the coming year
- Associated pathologies other than spinal (orthopedic, neurological, vascular, cardiac...) that can affect locomotion
- Root damage with motor deficit <3
- Altered comprehension skills making self-assessment impossible
- Patient subject to a protective measure (guardianship, curatorship)
Show all 10Show fewer
- Patient subject to a judicial protection
- Pregnant, parturient or breastfeeding woman
- Not fluent in French
- Patient who has already completed a multimodal rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.
Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.
In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.
- Conditions
- Chronic Low-back Pain
- Being tested
- Evaluation, Questionnaires, Rehabilitation care program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
- Functional tests: 400-meter walking test, 200-meter brisk walking test, Sorensen test, Shirado test, measurement of maximum isometric force of extensors/back flexors.
- 3D analysis of locomotion and posture
- Test of the flexion-relaxation phenomenon of the lumbar erector muscles
QuestionnairesOther
Self-questionnaires: Oswestry, Québec, SF-12, VAS pain, HAD, pain dramatization questionnaire, physical activity questionnaires, VAS and GPE satisfaction, FABQ, GPE functional status and EPICES score.
Rehabilitation care programOther
- Personalized global exercises (aerobics) on ergometers
- Muscle strengthening with resistance
- Balneotherapy
- Learning health skills related to their condition (therapeutic education)
- Personal and group motivational interviews
- Nutritional advice
- Relaxation session
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of good medium-term responders in a multimodal rehabilitation program
Measured: M13 (12 months after the end of the program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start24 Jan 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Why it stopped: The Covid pandemic made it impossible to monitor and rehabilitate patients at the Dijon Bourgogne CHU's CCR. A new home rehabilitation programme was set up. This new rehabilitation programme rendered the study obsolete and the project was abandoned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128098
- Sponsor's protocol ID
- ORNETTI PCA 2018-2
- Acronym
- FRELOMB
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2019
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04128098
- Acronym / sponsor ID
- FRELOMB / ORNETTI PCA 2018-2
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Covid pandemic made it impossible to monitor and rehabilitate patients at the Dijon Bourgogne CHU's CCR. A new home rehabilitation programme was set up. This new rehabilitation programme rendered the study obsolete and the project was abandoned.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 16 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.
Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.
Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.
In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient presenting for consultation in the re-education and rehabilitation department of the CHU Dijon Bourgogne
Key inclusion criteria (5 listed)
- Adult patient
- Having provided oral consent
- Chronic non-specific low back pain (HAS2015 criteria)
- Eligible for a rehabilitation program
- Patient affiliated or benefiting from a social security scheme
Key exclusion criteria (10 listed)
- Adult unable to provide consent
- Lumbar spine surgery scheduled in the coming year
- Associated pathologies other than spinal (orthopedic, neurological, vascular, cardiac...) that can affect locomotion
- Root damage with motor deficit <3
- Altered comprehension skills making self-assessment impossible
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 |
|---|---|---|
| Evaluation* Functional tests: 400-meter walking test, 200-meter brisk walking test, Sorensen test, Shirado test, measurement of maximum isometric force of extensors/back flexors. * 3D analysis of locomotion and posture * Test of the flexion-relaxation phenomenon of the lumbar erector muscles | Other | – |
| QuestionnairesSelf-questionnaires: Oswestry, Québec, SF-12, VAS pain, HAD, pain dramatization questionnaire, physical activity questionnaires, VAS and GPE satisfaction, FABQ, GPE functional status and EPICES score. | Other | – |
| Rehabilitation care program* Personalized global exercises (aerobics) on ergometers * Muscle strengthening with resistance * Balneotherapy * Learning health skills related to their condition (therapeutic education) * Personal and group motivational interviews * Nutritional advice * Relaxation session | Other | – |
Primary outcome
Proportion of good medium-term responders in a multimodal rehabilitation program
Time frame: M13 (12 months after the end of the program)
Results and safety
The study was stopped early (reason given: The Covid pandemic made it impossible to monitor and rehabilitate patients at the Dijon Bourgogne CHU's CCR. A new home rehabilitation programme was set up. This new rehabilitation programme rendered the study obsolete and the project was abandoned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Low-back Pain, run by Centre Hospitalier Universitaire Dijon 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 10 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: stopped early, as of the sponsor's last update on 16 Oct 2023. 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 was stopped early (reason given: The Covid pandemic made it impossible to monitor and rehabilitate patients at the Dijon Bourgogne CHU's CCR. A new home rehabilitation programme was set up. This new rehabilitation programme rendered the study obsolete and the project was abandoned.). Results are not available in the source record.
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?
Proportion of good medium-term responders in a multimodal rehabilitation program (time frame: M13 (12 months after the end of the program)). 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 16 Oct 2023.