Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
An evaluation study of the impact of the Axomove Therapy® medical device on subacute or chronic low back pain patients leaving rehabilitation centres to facilitate self-rehabilitation. A prospective, randomized, open-label, multicentre study whose main objective is to evaluate the effectiveness of the Axomove Therapy Medical Device on disability reduction (Oswestry disability index score) patients with subacute or chronic low back pain requiring rehabilitation.

Official Title
-----------------
Assessment of the Impact of the Axomove Therapy® Medical Device on Subacute or Chronic Low Back Pain Patients Leaving Rehabilitation Centres to Facilitate Self-rehabilitation: a Multicentre Randomized Controlled Study.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: AXOMOVE Therapy Medical Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18-65 years, Patients with subacute or chronic low back pain, day hospital follow-up (HDJ) or weekday hospital with a planned return home within 2 weeks of the inclusion visit (J0), Patient with common low back pain for at least 6 weeks before hospitalization, Patient having a smartphone, tablet/ or computer (compatible with the technical requirements of the DM) and having the possibility to connect (via a telephone subscription or a WIFI connection), Patient agreeing to install the Axomove Therapy® application and agreeing to follow the study protocol, Patient with physical, sensory and cognitive ability to use an application (digital tools) on a smartphone, tablet or computer and perform physical exercise programs, A patient who is a member of, or in receipt of, a social security scheme. Exclusion Criteria: Patients who are unable to understand, read or speak French, Inability to receive informed information, A patient with a sensory, visual or tactile impairment that prevents the correct use of a smartphone, tablet and/or computer, or prevents the exercise from being carried out safely, Patient with suspected or proven serious pathology such as recent vertebral fractures (less than 6 months), infection, malignant tumors and/or radiculopathy, Patient with a history of rheumatic inflammatory disease, Patient with true radiculalgia, Patient with scoliosis > 30°, Patient with lumbar surgery in the past 12 months, Pregnant patient, parturient or breastfeeding, Patient under legal protection (guardianship, curatorship), A patient with a serious and/or uncontrolled illness that, in the opinion of the investigator, could result in unacceptable safety risks or compromise protocol compliance, for example: an active or uncontrolled infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXOMOVE Therapy<br>Use of a web and mobile application for remote monitoring and rehabilitation | Other: AXOMOVE Therapy Medical Device<br>* Personalized exercise programs for the self-rehabilitation of low back pain patients<br>|
| No Intervention: Routine care<br>Current rehabilitation support care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AXOMOVE Therapy | Functional capacity of patients measured through the Oswestry Disability Index score | 14 weeks (105 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of patient physical activity | Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF) | day 0 (inclusion), day 15, day 45 and day 105 | 
| Quality of life | Quality of life measured by the EQ5D5L questionnaire | day 0 (inclusion), day 15, day 45 and day 105 | 
| Quality of life | Quality of life measured by the SF36 questionnaire | day 0 (inclusion), day 15, day 45 and day 105 | 
| Efficacy of AXOMOVE Therapy | Functional capacity of patients measured through the Oswestry Disability Index score (ODI) | day 0 (inclusion), day 15, day 45 |