NCT03801941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

January 3, 2019

Last Update Submit

February 28, 2022

Conditions

Chronic Low Back Pain

Keywords

Low back painMedical deviceSpineRehabilitationTraction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain release with the ATLAS device during standardized daily activities

    at day the 1st , 4th day of a 4 weeks rehabilitation program.

  • Percentage of improved patients

    at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.

  • Percentage of patients relieved with the ATLAS device

    at day the 1st , 4th and 5th day of a 4 weeks rehabilitation program.

Study Arms (2)

Group A

EXPERIMENTAL

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 dayOther: wearing ATLAS device during evaluation at 5th day

Group B

EXPERIMENTAL

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 dayOther: wearing ATLAS device during evaluation at 5th day

Interventions

wearing ATLAS device during evaluation at 4th dayDEVICE

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.

Group AGroup B
wearing ATLAS device during evaluation at 5th dayOTHER

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 AGroup B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic low back pain for more than 3 month
  • Analogical visual scale superior or egal to 3/10
  • BMI \< 30
  • \< Age \< 75 years
  • Patients who signed the informed consent
  • Hospital Anxiety and depression score less than 11

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Swynghedau, CHU

Lille, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent Tiffreau, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 14, 2019

Study Start

April 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

FR(1)