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

NCT ID: NCT05910463

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2024-09-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AXOMOVE Therapy

Use of a web and mobile application for remote monitoring and rehabilitation

Group Type: EXPERIMENTAL

AXOMOVE Therapy Medical Device

Intervention Type: OTHER

Personalized exercise programs for the self-rehabilitation of low back pain patients

Routine care

Current rehabilitation support care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AXOMOVE Therapy Medical Device

Personalized exercise programs for the self-rehabilitation of low back pain patients

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axomove

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie WIECZOREK, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Locations

CHRU de LILLE

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucie POUPARD

Role: CONTACT

lucie.poupard@axomove.com

0675385354

Facility Contacts

Valérie WIECZOREZ, MD

Role: primary

Other Identifiers

KM00369

Identifier Type: -

Identifier Source: org_study_id