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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: wearing ATLAS device during evaluation at 4th day; Other: wearing ATLAS device during evaluation at 5th day

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Swynghedau, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.; Other: 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.
EXPERIMENTAL: 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.	Device: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 5th day of a 4 weeks rehabilitation program.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain release with the ATLAS device during standardized daily activities	Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) from 0 to	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).	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).	at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: JAPET MEDICAL DEVICE
• Investigators: Principal Investigator: Vincent Tiffreau, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Low back pain; Traction; Medical device; Spine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2016_67; 2018-A01729-46 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No