Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXOMOVE Therapy | Experimental | Use of a web and mobile application for remote monitoring and rehabilitation |
|
| Routine care | No Intervention | Current rehabilitation support care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXOMOVE Therapy Medical Device | Other | Personalized exercise programs for the self-rehabilitation of low back pain patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of AXOMOVE Therapy | Functional capacity of patients measured through the Oswestry Disability Index score | 14 weeks (105 days) |
| 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 |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucie POUPARD | Contact | 0675385354 | lucie.poupard@axomove.com |
| Name | Affiliation | Role |
|---|---|---|
| Valerie WIECZOREK, MD | CHU de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de LILLE | Recruiting | Lille | 59000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |