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

NCT05910463 | Unknown

• 1 other identifier: KM00369
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of AXOMOVE Therapy

  Functional capacity of patients measured through the Oswestry Disability Index score

  14 weeks (105 days)

Secondary Outcomes (4)

• Level of patient physical activity

  day 0 (inclusion), day 15, day 45 and day 105

• Quality of life

  day 0 (inclusion), day 15, day 45 and day 105

• Quality of life

  day 0 (inclusion), day 15, day 45 and day 105

• Efficacy of AXOMOVE Therapy

  day 0 (inclusion), day 15, day 45

Study Arms (2)

AXOMOVE Therapy

EXPERIMENTAL

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

Other: AXOMOVE Therapy Medical Device

Routine care

NO INTERVENTION

Current rehabilitation support care

Interventions

AXOMOVE Therapy Medical Device OTHER

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

AXOMOVE Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18-65 years,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axomove: lead

Study Sites (1)

CHRU de LILLE

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerie WIECZOREK, MD

  CHU de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucie POUPARD

CONTACT

0675385354; lucie.poupard@axomove.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 18, 2023
• Study Start: June 28, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)