Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients (AVA-PREPA)

Axomove

Status

Enrolling

Conditions

Low Back Pain

Treatments

Other: AXOMOVE Therapy Medical Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05910463

KM00369

Details and patient eligibility

About

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.

Enrollment

190 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.