Clinical trial NCT03801941: Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Low back pain
Medical device
Spine
Rehabilitation
Traction
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Japet Medical Devices
First posted: 2019-01-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain release with the ATLAS device during standardized daily activities
timeFrame: at 5th day of a 4 weeks rehabilitation program.
Secondary outcomes:
measure: Pain release with the ATLAS device during standardized daily activities
timeFrame: at day the 1st , 4th day of a 4 weeks rehabilitation program.
measure: Percentage of improved patients
timeFrame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
measure: Percentage of patients relieved with the ATLAS device
timeFrame: at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swynghedau, CHU
Study officials:
affiliation: University Hospital, Lille
name: Vincent Tiffreau, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: