Back to resultsEfficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease (AmbuTract)
Primary Purpose
Lumbar Disc Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visual analog scale
Mac Gill Pain Questionnaire
Roland and Morris Disability Questionnaire
Quebec questionnaire
Sponsored by
About this trial
This is an interventional other trial for Lumbar Disc Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Hôpital Privé Le Bois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ATLAS
Standard lumbar support belt
Arm Description
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
Standard lumbar support belt : LombaSkin® or Lombogib®
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To assess the safety and tolerance of the devices
Analysis of all adverse events collected during the study
Satisfaction of the patient
Percentage of patients with an overall assessment of the device
Full Information
NCT ID
NCT04585386
First Posted
October 12, 2020
Last Updated
June 17, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04585386
Brief Title
Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease
Acronym
AmbuTract
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision: no sufficient patient
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATLAS
Arm Type
Experimental
Arm Description
Medical device named ATLAS which is an "active corset" (rigid lumbar restraint) and connected.
Arm Title
Standard lumbar support belt
Arm Type
Active Comparator
Arm Description
Standard lumbar support belt : LombaSkin® or Lombogib®
Intervention Type
Other
Intervention Name(s)
Visual analog scale
Intervention Description
to measure the lumbar and radicular pain felt by the patient.
Intervention Type
Other
Intervention Name(s)
Mac Gill Pain Questionnaire
Intervention Description
self-questionnaire that allows a qualitative assessment of chronic pain
Intervention Type
Other
Intervention Name(s)
Roland and Morris Disability Questionnaire
Intervention Description
functional disability scale for assessing low back pain
Intervention Type
Other
Intervention Name(s)
Quebec questionnaire
Intervention Description
To access the patient's perception of incapacity
Primary Outcome Measure Information:
Title
Evolution of the lumbar pain
Description
The primary outcome measure is the change in lumbar pain assessed by the patient using an VAS from 0 to 100 mm.
Time Frame
1 hour after the start of the port
Secondary Outcome Measure Information:
Title
To assess the safety and tolerance of the devices
Description
Analysis of all adverse events collected during the study
Time Frame
Between Day 0 and Day 8
Title
Satisfaction of the patient
Description
Percentage of patients with an overall assessment of the device
Time Frame
After a period of 8 days of wearing the medical device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Facility Information:
Facility Name
Hôpital Privé Le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the ATLAS Medical Device on Pain in Patients With Low Back Pain Due to Lumbar Disc Disease
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