Chronic Low Back PainATLASNCT03801941
Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
A study testing wearing ATLAS device during evaluation at 4th day and wearing ATLAS device during evaluation at 5th day in people with Chronic Low Back Pain, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain. This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- wearing ATLAS device during evaluation at 4th day and wearing ATLAS device during evaluation at 5th day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Jun 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
- Chronic low back pain for more than 3 month
- Analogical visual scale superior or egal to 3/10
- BMI < 30
- 18 < Age < 75 years
- Patients who signed the informed consent
- Hospital Anxiety and depression score less than 11
Who cannot join
- - Neurological or radicular deficit
- Skin pathology of the trunk region
- Antecedent of surgery of spinal fusion
- Implanted neurostimulation treatment
- Scoliosis with Cobb angle > 30°
- History of vertebral fracture
Show all 12Show fewer
- BMI > 30
- Respiratory failure
- Recent rib fracture (less than 3 month)
- Pregnancy or breastfeeding
- Osteoporosis
- Refusal to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.
This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.
Read the detailed description
This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients affected by chronic low back pain.
Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation program.
Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS study is carried out during the 5 first days of the rehabilitation program.
Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5 standardized activities (the most intensive pain during the 5 activities is recorded), with and without wearing the ATLAS device.
Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without wearing the device. Percentage of relieved patients (percentage of patient reporting pain intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.
Randomization: two groups (i.e. group A and B). Primary outcome is evaluated at day 4 and 5, with a crossover design (Group A: pain is evaluated during activities with the device at day 4 and without the device at day 5. Group B: pain is evaluated during activities without the device at day 4 and with the device at day 5).
- Conditions
- Chronic Low Back Pain
- Being tested
- wearing ATLAS device during evaluation at 4th day, wearing ATLAS device during evaluation at 5th day
- Keywords
- Low back pain, Medical device, Spine, Rehabilitation, Traction
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing ATLAS device during evaluation at 4th dayDevice
Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
wearing ATLAS device during evaluation at 5th dayOther
Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with the ATLAS Device at the 4th day and without the device at the 5th day of a 4 weeks rehabilitation program. Receives: Device: wearing ATLAS device during evaluation at 4th day; Other: wearing ATLAS device during evaluation at 5th day |
| Group B | Experimental | Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without the ATLAS Device at the 4th day and with the device at the 5th day of a 4 weeks rehabilitation program. Receives: Device: wearing ATLAS device during evaluation at 4th day; Other: wearing ATLAS device during evaluation at 5th day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain release with the ATLAS device during standardized daily activities
Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to 100 mm (0 means no pain and 100 means extremely severe pain) during the standardized daily activities (the most intense pain reported during the 5 activities is recorded).
Measured: at 5th day of a 4 weeks rehabilitation program.
Secondary outcomes (3)
Pain release with the ATLAS device during standardized daily activities
Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to
Measured: at day the 1st , 4th day of a 4 weeks rehabilitation program.
Percentage of improved patients
Percentage of patients reporting pain improvement of at least 20 mm on the Visual Analogue Scale with the ATLAS device during the 5 standardized daily activities compared to the pain reported without wearing the ATLAS device during the same 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).
Measured: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
Percentage of patients relieved with the ATLAS device
Percentage of patients wearing the ATLAS device reporting pain intensity less than 30 mm on a 100mm Visual Analogue scale during the 5 standardized daily activities (the most intense pain reported during the 5 activities is recorded).
Measured: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 University Hospital, LilleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Japet Medical Devices
- Responsible party
- Sponsor
- Investigators
- Vincent Tiffreau, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801941
- Sponsor's protocol ID
- 2016_67
- Other IDs
- 2018-A01729-46
- Acronym
- ATLAS
- Status last verified
- Feb 2022
- First submitted
- 3 Jan 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device
- ClinicalTrials.gov ID
- NCT03801941
- Acronym / sponsor ID
- ATLAS / 2016_67
- Conditions
- Chronic Low Back Pain
- Keywords
- Low back pain, Medical device, Spine, Rehabilitation, Traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Japet Medical Devices
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jan 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 aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.
This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.
Detailed description
This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients affected by chronic low back pain.
Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation program.
Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS study is carried out during the 5 first days of the rehabilitation program.
Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5 standardized activities (the most intensive pain during the 5 activities is recorded), with and without wearing the ATLAS device.
Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without wearing the device. Percentage of relieved patients (percentage of patient reporting pain intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.
Randomization: two groups (i.e. group A and B). Primary outcome is evaluated at day 4 and 5, with a crossover design (Group A: pain is evaluated during activities with the device at day 4 and without the device at day 5. Group B: pain is evaluated during activities without the device at day 4 and with the device at day 5).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: wearing ATLAS device during evaluation at 4th day, Other: wearing ATLAS device during evaluation at 5th dayWearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with the ATLAS Device at the 4th day and without the device at the 5th day of a 4 weeks rehabilitation program. |
| Group B | Experimental | Device: wearing ATLAS device during evaluation at 4th day, Other: wearing ATLAS device during evaluation at 5th dayWearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without the ATLAS Device at the 4th day and with the device at the 5th day of a 4 weeks rehabilitation program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic low back pain for more than 3 month
- Analogical visual scale superior or egal to 3/10
- BMI < 30
- 18 < Age < 75 years
- Patients who signed the informed consent
Key exclusion criteria (12 listed)
- - Neurological or radicular deficit
- Skin pathology of the trunk region
- Antecedent of surgery of spinal fusion
- Implanted neurostimulation treatment
- Scoliosis with Cobb angle > 30°
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 |
|---|---|---|
| wearing ATLAS device during evaluation at 4th dayWearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program. | Device | Group A, Group B |
| wearing ATLAS device during evaluation at 5th dayWearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program. | Other | Group A, Group B |
Primary outcome
Pain release with the ATLAS device during standardized daily activities
Time frame: at 5th day of a 4 weeks rehabilitation program.
Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to 100 mm (0 means no pain and 100 means extremely severe pain) during the standardized daily activities (the most intense pain reported during the 5 activities is recorded).
3 secondary outcomes
Pain release with the ATLAS device during standardized daily activities
Time frame: at day the 1st , 4th day of a 4 weeks rehabilitation program.
Percentage of improved patients
Time frame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
Percentage of patients relieved with the ATLAS device
Time frame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
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 2 Mar 2022.
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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.
Vincent Tiffreau, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing ATLAS device during evaluation at 4th day and wearing ATLAS device during evaluation at 5th day in people with Chronic Low Back Pain, run by University Hospital, Lille 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 12 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 2 Mar 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 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?
Pain release with the ATLAS device during standardized daily activities (time frame: at 5th day of a 4 weeks rehabilitation 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 2 Mar 2022.