Low Back Pain
Conditions
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.
Interventions
OTHERAXOMOVE Therapy Medical Device
Personalized exercise programs for the self-rehabilitation of low back pain patients
Sponsors
Axomove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of AXOMOVE Therapy | 14 weeks (105 days) | Functional capacity of patients measured through the Oswestry Disability Index score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of patient physical activity | day 0 (inclusion), day 15, day 45 and day 105 | Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF) |
| Quality of life | day 0 (inclusion), day 15, day 45 and day 105 | Quality of life measured by the EQ5D5L questionnaire |
| Efficacy of AXOMOVE Therapy | day 0 (inclusion), day 15, day 45 | Functional capacity of patients measured through the Oswestry Disability Index score (ODI) |
Countries
France
Contacts
Primary ContactLucie POUPARD
Outcome results
None listed