Low Back PainLumbaCure2303NCT06203886
Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP.
A study testing LumbaCure in people with Low Back Pain, run by Odix at 1 site in Belgium.
Trial summary
The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- LumbaCure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2023to 18 Jul 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic or sub-acute low back pain (without "red flag")
- The subject, a resident or worker at the investigation site (nursing home), over 60 years of age
- Ability to communicate with the physiotherapist.
- Ability to remain in a sitting position for at least 10 minutes.
- A level of back pain > 2 on the numerical pain rating scale
Who cannot join
- Suspected or confirmed serious pathology (infection, fracture, cancer, inflammatory arthritis, ....) related to the back/spine.
- Body weight > 120 kg
- Subject is non-ambulatory or has severely reduced mobility.
- Dominant component of radicular pain (common lumbago with distal radiation below the knee)
- Radiculopathy
- Severe cardiorespiratory disease
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- Dementia or significant cognitive impairment that prevents the participant from giving consent, completing study questionnaires or complying with recommendations.
- Fracture or operation less than 3 months old of the spine, pelvis, hip or leg bones.
- Known vertebral pathology other than osteoarthritis.
- Major neurological disease, movement or motor neuron disorders
- Fibromyalgia or other systemic rheumatic disease
- Recent history of stroke or heart failure, unstable heart condition
- Uncontrolled substance abuse disorders
- Invasive procedures to relieve pain in the last 3 months
- Acute or terminal illness
- Any other medical condition considered by the study team to be a contraindication to the study.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
ASBL " Mère Joséphine " - MRS Saint Joseph Blegny
Blégny, Liège, 4670
About this study
Official title: Exploratory Clinical Investigation of the LumbaCure® Medical Device Used in Elderly People Suffering From Chronic Low Back Pain.
The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.
- Conditions
- Low Back Pain
- Being tested
- LumbaCure
- 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.
LumbaCureDevice
LumbaCure® is a device developed to induce specific mobilization of the lower back in patients requiring physical rehabilitation for orthopaedic disorders, particularly chronic low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Test Intervention arm | Experimental | LumbaCure robotic device Receives: Device: LumbaCure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10
Measured: Change between baseline and Visit 3 (Day 28)
Secondary outcomes (10)
Functional mobility
Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded
Measured: Between baseline and visit 3 (day 28)
Functional mobility
Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded
Measured: Between baseline and visit 2 (Day 14)
Functional mobility
Change in the time taken to complete the time up and go (TUG) test. The TUG consists of measuring the time it takes a person to get up from a chair, walk 3 metres at their usual pace, turn around, return to the chair and sit down. Two attempts are made and the best time is recorded
Measured: Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4)
Low back pain
Weekly changes from baseline in mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10.
Measured: Between baseline and each week through study completion, one month.
Low back pain
Current back pain intensity before and after each session, assessed on a numerical pain rating scale from 0 to 10.
Measured: Before and after each session [12 measures, 3x/week during one month]
Low back pain
Changes in mean intensity of low back pain in the last week, assessed on a numerical rating scale from 0 to 10, during the follow-up period between the end of the investigation period and 1 month post-study.
Measured: Follow-up : Between end of the investigation period [Day 28] and 1 month post-study.
Overall satisfaction of the physiotherapist with the LumbaCure® intervention
A single satisfaction score will be reported at the end of the intervention period by the physiotherapist:
- How satisfied or dissatisfied are you with the ability of the LumbaCure® device intervention to improve your patient's low back pain condition (7 point scale)?
- To what extent are you satisfied or dissatisfied with the ability of the LumbaCure® device to improve your patient's mobilisation (7-point scale)?
Measured: End of intervention period [Day 28]
Overall patient satisfaction with the LumbaCure® intervention
A single satisfaction score will be calculated at the end of the intervention period based on a series of three questions :
- How satisfied or dissatisfied are you with the ability of the LumbaCure® procedure to improve your lower back pain (7 point scale)?
- How satisfied or dissatisfied are you with the ability of the LumbaCure® procedure to improve your mobility?
- How would you rate your overall experience with the LumbaCure® device (7-point scale)?
Measured: End of intervention period [Day 28]
Risk of falling
Change in the risk of falling between baseline and the end of the intervention period, visit 3 (day 28), assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk.
Measured: Between baseline and the end of the investigation,visit 3 [Day 28]
Risk of falling
Changes in the risk of falling during the follow-up period assessed by the Tinetti test. This test is a comprehensive assessment of both balance and gait. It assesses the patient's ability to change position, maintain balance in different situations and walk.
Measured: Between the end of the investigation,visit 3 [Day 28] and one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start11 Dec 2023
- Primary completion17 Jun 2024
- Study completion18 Jul 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203886
- Sponsor's protocol ID
- CIV-23-09-043961
- Acronym
- LumbaCure2303
- Status last verified
- Aug 2024
- First submitted
- 13 Dec 2023
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Investigation of the LumbaCure® Medical Device Used in Elderly People Suffering From Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT06203886
- Acronym / sponsor ID
- LumbaCure2303 / CIV-23-09-043961
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OdixIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 12 Jan 2024 (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.
The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Intervention arm | Experimental | Device: LumbaCureLumbaCure robotic device |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic or sub-acute low back pain (without "red flag")
- The subject, a resident or worker at the investigation site (nursing home), over 60 years of age
- Ability to communicate with the physiotherapist.
- Ability to remain in a sitting position for at least 10 minutes.
- A level of back pain > 2 on the numerical pain rating scale
Key exclusion criteria (16 listed)
- Suspected or confirmed serious pathology (infection, fracture, cancer, inflammatory arthritis, ....) related to the back/spine.
- Body weight > 120 kg
- Subject is non-ambulatory or has severely reduced mobility.
- Dominant component of radicular pain (common lumbago with distal radiation below the knee)
- Radiculopathy
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 |
|---|---|---|
| LumbaCureLumbaCure® is a device developed to induce specific mobilization of the lower back in patients requiring physical rehabilitation for orthopaedic disorders, particularly chronic low back pain. | Device | Test Intervention arm |
Primary outcome
Low back pain
Time frame: Change between baseline and Visit 3 (Day 28)
Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10
10 secondary outcomes
Functional mobility
Time frame: Between baseline and visit 3 (day 28)
Functional mobility
Time frame: Between baseline and visit 2 (Day 14)
Functional mobility
Time frame: Follow-up period : between the end of the investigation period and 1 month post-study (Day 56 - Visit 4)
Low back pain
Time frame: Between baseline and each week through study completion, one month.
Low back pain
Time frame: Before and after each session [12 measures, 3x/week during one month]
Low back pain
Time frame: Follow-up : Between end of the investigation period [Day 28] and 1 month post-study.
Overall satisfaction of the physiotherapist with the LumbaCure® intervention
Time frame: End of intervention period [Day 28]
Overall patient satisfaction with the LumbaCure® intervention
Time frame: End of intervention period [Day 28]
Risk of falling
Time frame: Between baseline and the end of the investigation,visit 3 [Day 28]
Risk of falling
Time frame: Between the end of the investigation,visit 3 [Day 28] and one month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LumbaCure in people with Low Back Pain, run by Odix at 1 site in Belgium.
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 16 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: finished, as of the sponsor's last update on 29 Aug 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain (time frame: Change between baseline and Visit 3 (Day 28)). 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 29 Aug 2024.