Lumbar Disc DiseaseAmbuTractNCT04585386
Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease
A study testing Visual analog scale, Mac Gill Pain Questionnaire and Roland and Morris Disability Questionnaire in people with Lumbar Disc Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- Visual analog scale, Mac Gill Pain Questionnaire and Roland and Morris Disability Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2021to 7 Oct 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from subacute (for 6 to 12 weeks) or chronic (> 3 months) lumbar pain;
- Lumbar disc disease confirmed by Magnetic Resonance Imaging (MRI) less than 3 months old;
- Patient with lumbar pain ≥ 40mm on the visual analogue scale (VAS) at inclusion;
- Patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity;
- Patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations;
- Patient capable of understanding the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), of reading the information leaflet, of completing questionnaires and agreeing to sign the consent form.
Who cannot join
- Patient with neurological radicular or medullary deficits;
- Patient presenting a postural problem with lateralized contracture;
- Skin pathology in the trunk region and / or contusions and injuries by stretching the trunk;
- History of spinal arthrodesis surgery;
- History of cauda equina syndrome;
- Patient treated by implanted neurostimulation;
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- Scoliosis with Cobb angle> 30 °;
- History of recent fracture of the dorsolumbar spine (<3 months);
- History of recent rib fracture (<3 months);
- History of recent herniated disc surgery (<3 months);
- Patient with diagnosed fracture osteoporosis;
- Patient with heart or circulatory disease or respiratory failure;
- Patient presenting with a tumor or infectious process of the vertebrae;
- Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not beneficiary of a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess the Efficacy of the ATLAS Medical Device on Pain in Patients With Subacute or Chronic Low Back Pain With Lumbar Disc Disease: Prospective, Randomized Trial (AmbuTract)
Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.
Read the detailed description
The main expected benefit is a reduction in pain experienced in patients with subacute or chronic low back pain during and after wear. Consequently, an improvement in the quality of daily life is expected with a less significant impact of low back pain.
The main objective of the study is to compare the efficacy of the ATLAS medical device with a standard lumbar support belt in terms of immediate reduction of low back pain experienced in patients with subacute or chronic low back pain.
- Conditions
- Lumbar Disc Disease
- Being tested
- Visual analog scale, Mac Gill Pain Questionnaire, Roland and Morris Disability Questionnaire, Quebec questionnaire
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual analog scaleOther
to measure the lumbar and radicular pain felt by the patient.
Mac Gill Pain QuestionnaireOther
self-questionnaire that allows a qualitative assessment of chronic pain
Roland and Morris Disability QuestionnaireOther
functional disability scale for assessing low back pain
Quebec questionnaireOther
To access the patient's perception of incapacity
| Study group | Role | What they receive |
|---|---|---|
| ATLAS | Experimental | Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected. Receives: Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire |
| Standard lumbar support belt | Active comparator | Standard lumbar support belt : LombaSkin® or Lombogib® Receives: Other: Visual analog scale; Other: Mac Gill Pain Questionnaire; Other: Roland and Morris Disability Questionnaire; Other: Quebec questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the lumbar pain
The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.
Measured: 1 hour after the start of the port
Secondary outcomes (2)
To assess the safety and tolerance of the devices
Analysis of all adverse events collected during the study
Measured: Between Day 0 and Day 8
Satisfaction of the patient
Percentage of patients with an overall assessment of the device
Measured: After a period of 8 days of wearing the medical device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start18 Aug 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: Sponsor decision: no sufficient patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585386
- Sponsor's protocol ID
- 2020-A01625-34
- Acronym
- AmbuTract
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2020
- Last updated
- 23 Jun 2022
- Results posted
- 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 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Efficacy of the ATLAS Medical Device on Pain in Patients With Subacute or Chronic Low Back Pain With Lumbar Disc Disease: Prospective, Randomized Trial (AmbuTract)
- ClinicalTrials.gov ID
- NCT04585386
- Acronym / sponsor ID
- AmbuTract / 2020-A01625-34
- Conditions
- Lumbar Disc Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision: no sufficient patient
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 14 Oct 2020 (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.
Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.
Detailed description
The main expected benefit is a reduction in pain experienced in patients with subacute or chronic low back pain during and after wear. Consequently, an improvement in the quality of daily life is expected with a less significant impact of low back pain.
The main objective of the study is to compare the efficacy of the ATLAS medical device with a standard lumbar support belt in terms of immediate reduction of low back pain experienced in patients with subacute or chronic low back pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATLAS | Experimental | Other: Visual analog scale, Other: Mac Gill Pain Questionnaire, Other: Roland and Morris Disability Questionnaire, Other: Quebec questionnaireMedical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected. |
| Standard lumbar support belt | Active comparator | Other: Visual analog scale, Other: Mac Gill Pain Questionnaire, Other: Roland and Morris Disability Questionnaire, Other: Quebec questionnaireStandard lumbar support belt : LombaSkin® or Lombogib® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient suffering from subacute (for 6 to 12 weeks) or chronic (> 3 months) lumbar pain;
- Lumbar disc disease confirmed by Magnetic Resonance Imaging (MRI) less than 3 months old;
- Patient with lumbar pain ≥ 40mm on the visual analogue scale (VAS) at inclusion;
- Patient in whom a lumbar belt / restraint is considered for a short period to help resumption of activity;
- Patient with internet and a camera (by phone or computer) and agreeing to use them as part of the study's teleconsultations;
Key exclusion criteria (16 listed)
- Patient with neurological radicular or medullary deficits;
- Patient presenting a postural problem with lateralized contracture;
- Skin pathology in the trunk region and / or contusions and injuries by stretching the trunk;
- History of spinal arthrodesis surgery;
- History of cauda equina syndrome;
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 |
|---|---|---|
| Visual analog scaleto measure the lumbar and radicular pain felt by the patient. | Other | ATLAS, Standard lumbar support belt |
| Mac Gill Pain Questionnaireself-questionnaire that allows a qualitative assessment of chronic pain | Other | ATLAS, Standard lumbar support belt |
| Roland and Morris Disability Questionnairefunctional disability scale for assessing low back pain | Other | ATLAS, Standard lumbar support belt |
| Quebec questionnaireTo access the patient's perception of incapacity | Other | ATLAS, Standard lumbar support belt |
Primary outcome
Evolution of the lumbar pain
Time frame: 1 hour after the start of the port
The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.
2 secondary outcomes
To assess the safety and tolerance of the devices
Time frame: Between Day 0 and Day 8
Satisfaction of the patient
Time frame: After a period of 8 days of wearing the medical device
Results and safety
The study was stopped early (reason given: Sponsor decision: no sufficient patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- 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.
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?
A study testing Visual analog scale, Mac Gill Pain Questionnaire and Roland and Morris Disability Questionnaire in people with Lumbar Disc Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 inclusion and 16 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 23 Jun 2022. 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: Sponsor decision: no sufficient patient). 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?
Evolution of the lumbar pain (time frame: 1 hour after the start of the port). 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 23 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.