Clinical trial NCT05910463: Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Axomove
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy of AXOMOVE Therapy
timeFrame: 14 weeks (105 days)
Secondary outcomes:
measure: Level of patient physical activity
timeFrame: day 0 (inclusion), day 15, day 45 and day 105
measure: Quality of life
timeFrame: day 0 (inclusion), day 15, day 45 and day 105
measure: Quality of life
timeFrame: day 0 (inclusion), day 15, day 45 and day 105
measure: Efficacy of AXOMOVE Therapy
timeFrame: day 0 (inclusion), day 15, day 45
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de LILLE
Study officials:
affiliation: CHU de Lille
name: Valerie WIECZOREK, MD
role: PRINCIPAL_INVESTIGATOR
References: