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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: AXOMOVE Therapy Medical Device

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie POUPARD; Phone Number: 0675385354; Email: lucie.poupard@axomove.com

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • CHRU de Lille
    • Contact: Valérie WIECZOREZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXOMOVE Therapy; Use of a web and mobile application for remote monitoring and rehabilitation	Other: AXOMOVE Therapy Medical Device; Personalized exercise programs for the self-rehabilitation of low back pain patients
No Intervention: Routine care; Current rehabilitation support care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of AXOMOVE Therapy	Functional capacity of patients measured through the Oswestry Disability Index score	14 weeks (105 days)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Axomove
• Investigators: Principal Investigator: Valerie WIECZOREK, MD, CHU de LILLE

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KM00369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No