Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
CompletedNot applicableNCT03801941
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Device: wearing ATLAS device during evaluation at 4th day
- Other: wearing ATLAS device during evaluation at 5th day
- Sponsor
- University Hospital, Lille
- Collaborators
- Japet Medical Devices
- Start date
- 2019-04-01
- Primary completion
- 2021-06-30
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * \- 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03801941