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
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.
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 →This is the only study on the registry with Axomove as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
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.
Use of a web and mobile application for remote monitoring and rehabilitation
Other: AXOMOVE Therapy Medical Device
Current rehabilitation support care
Personalized exercise programs for the self-rehabilitation of low back pain patients
Efficacy of AXOMOVE Therapy
Functional capacity of patients measured through the Oswestry Disability Index score
Time frame: 14 weeks (105 days)
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
Quality of life
Quality of life measured by the EQ5D5L questionnaire
Time frame: day 0 (inclusion), day 15, day 45 and day 105
Quality of life
Quality of life measured by the SF36 questionnaire
Time frame: 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)
Time frame: day 0 (inclusion), day 15, day 45
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.