Status:
COMPLETED
Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Japet Medical Devices
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- \- 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
- BMI \> 30
- Respiratory failure
- Recent rib fracture (less than 3 month)
- Pregnancy or breastfeeding
- Osteoporosis
- Refusal to participate to the study
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03801941
Start Date
April 1 2019
End Date
June 30 2021
Last Update
March 2 2022
Active Locations (1)
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1
Hôpital Swynghedau, CHU
Lille, France