Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)

NCT ID: NCT03801941

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-30

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).

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

wearing ATLAS device during evaluation at 4th day

Intervention Type: DEVICE

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 day

Intervention Type: OTHER

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.

Group B

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.

Group Type: EXPERIMENTAL

wearing ATLAS device during evaluation at 4th day

Intervention Type: DEVICE

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 day

Intervention Type: OTHER

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.

Interventions

wearing ATLAS device during evaluation at 4th day

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.

Intervention Type: DEVICE

wearing ATLAS device during evaluation at 5th day

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japet Medical Devices

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Tiffreau, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Swynghedau, CHU

Lille, , France

Countries

France

Other Identifiers

2018-A01729-46

Identifier Type: OTHER

Identifier Source: secondary_id

2016_67

Identifier Type: -

Identifier Source: org_study_id