An interventional study of LumbaCure in Low Back Pain, sponsored by Odix. Completed at 1 site in Belgium. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Odix · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Odix is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LumbaCure robotic device
Device: LumbaCure
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.
Low back pain
Mean intensity of low back pain during the last week, assessed on a numerical pain rating scale from 0 to 10
Time frame: Change 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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)?
Time frame: 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)?
Time frame: 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.
Time frame: 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.
Time frame: Between the end of the investigation,visit 3 [Day 28] and one month follow-up
Safety of the device
The number, intensity and severity of adverse events are reported before each LumbaCure session.
Time frame: through study completion, one month
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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