CClinicalTrials.gg
Status unknownNCT05910463AVA-PREPAUpdated Jul 21, 2023

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

An interventional study of AXOMOVE Therapy Medical Device in Low Back Pain, sponsored by Axomove. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Axomove · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 190 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

This is the only study on the registry with Axomove as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    AXOMOVE Therapy

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

    Other: AXOMOVE Therapy Medical Device

  • No intervention
    Routine care

    Current rehabilitation support care

Interventions

  • OtherAXOMOVE Therapy Medical Device

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

06

What researchers measure

Primary outcomes

  1. Efficacy of AXOMOVE Therapy

    Functional capacity of patients measured through the Oswestry Disability Index score

    Time frame: 14 weeks (105 days)

Secondary outcomes

  1. Level of patient physical activity

    Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF)

    Time frame: day 0 (inclusion), day 15, day 45 and day 105

  2. Quality of life

    Quality of life measured by the EQ5D5L questionnaire

    Time frame: day 0 (inclusion), day 15, day 45 and day 105

  3. Quality of life

    Quality of life measured by the SF36 questionnaire

    Time frame: day 0 (inclusion), day 15, day 45 and day 105

  4. Efficacy of AXOMOVE Therapy

    Functional capacity of patients measured through the Oswestry Disability Index score (ODI)

    Time frame: day 0 (inclusion), day 15, day 45

07

Study locations

1 of 1 sites recruiting
  • CHRU de LILLE
    Lille, 59000, France
    • Valérie WIECZOREZ, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05910463
Lead sponsor
Axomove
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Jun 28, 2023
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jul 21, 2023

Study contacts

Lucie POUPARD
Contact
lucie.poupard@axomove.com
0675385354
Valerie WIECZOREK, MD
principal investigator · CHU de Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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