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

Low Back Pain Clinical Trial

— AVA-PREPA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910463
• Other study ID #: KM00369
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Axomove
• Contact: Lucie POUPARD
• Phone: 0675385354
• Email: lucie.poupard[@]axomove.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• AXOMOVE Therapy Medical Device
Personalized exercise programs for the self-rehabilitation of low back pain patients

Locations

Country	Name	City	State
France	CHRU de LILLE	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Axomove

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of AXOMOVE Therapy	Functional capacity of patients measured through the Oswestry Disability Index score	14 weeks (105 days)
Secondary	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
Secondary	Quality of life	Quality of life measured by the EQ5D5L questionnaire	day 0 (inclusion), day 15, day 45 and day 105
Secondary	Quality of life	Quality of life measured by the SF36 questionnaire	day 0 (inclusion), day 15, day 45 and day 105
Secondary	Efficacy of AXOMOVE Therapy	Functional capacity of patients measured through the Oswestry Disability Index score (ODI)	day 0 (inclusion), day 15, day 45