Low Back PainAVA-PREPANCT05910463
Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients
A study testing AXOMOVE Therapy Medical Device in people with Low Back Pain, run by Axomove at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- AXOMOVE Therapy Medical Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de LILLE
Lille, 59000
Valérie WIECZOREZ, MD
About this study
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.
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
- Being tested
- AXOMOVE Therapy Medical Device
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXOMOVE Therapy Medical DeviceOther
Personalized exercise programs for the self-rehabilitation of low back pain patients
| Study group | Role | What they receive |
|---|---|---|
| AXOMOVE Therapy | Experimental | Use of a web and mobile application for remote monitoring and rehabilitation Receives: Other: AXOMOVE Therapy Medical Device |
| Routine care | No intervention | Current rehabilitation support care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of AXOMOVE Therapy
Functional capacity of patients measured through the Oswestry Disability Index score
Measured: 14 weeks (105 days)
Secondary outcomes (4)
Level of patient physical activity
Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF)
Measured: day 0 (inclusion), day 15, day 45 and day 105
Quality of life
Quality of life measured by the EQ5D5L questionnaire
Measured: day 0 (inclusion), day 15, day 45 and day 105
Quality of life
Quality of life measured by the SF36 questionnaire
Measured: 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)
Measured: day 0 (inclusion), day 15, day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start28 Jun 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axomove
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valerie WIECZOREK, MD, Principal investigator, CHU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910463
- Sponsor's protocol ID
- KM00369
- Acronym
- AVA-PREPA
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05910463
- Acronym / sponsor ID
- AVA-PREPA / KM00369
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- AxomoveIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXOMOVE Therapy | Experimental | Other: AXOMOVE Therapy Medical DeviceUse of a web and mobile application for remote monitoring and rehabilitation |
| Routine care | No intervention | –Current rehabilitation support care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXOMOVE Therapy Medical DevicePersonalized exercise programs for the self-rehabilitation of low back pain patients | Other | AXOMOVE Therapy |
Primary outcome
Efficacy of AXOMOVE Therapy
Time frame: 14 weeks (105 days)
Functional capacity of patients measured through the Oswestry Disability Index score
4 secondary outcomes
Level of patient physical activity
Time frame: day 0 (inclusion), day 15, day 45 and day 105
Quality of life
Time frame: day 0 (inclusion), day 15, day 45 and day 105
Quality of life
Time frame: day 0 (inclusion), day 15, day 45 and day 105
Efficacy of AXOMOVE Therapy
Time frame: day 0 (inclusion), day 15, day 45
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie WIECZOREK, MD principal investigator
CHU de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXOMOVE Therapy Medical Device in people with Low Back Pain, run by Axomove at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie POUPARD (0675385354, lucie.poupard@axomove.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of AXOMOVE Therapy (time frame: 14 weeks (105 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.