Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP. (LumbaCure2303)

August 28, 2024 updated by: Odix

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Liège
      • Blégny, Liège, Belgium, 4670
        • ASBL " Mère Joséphine " - MRS Saint Joseph Blegny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Intervention arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change between baseline and Visit 3 (Day 28)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional mobility
Time Frame: Between baseline and visit 3 (day 28)
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
Between baseline and visit 3 (day 28)
Functional mobility
Time Frame: Between baseline and visit 2 (Day 14)
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
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)
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
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.
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.
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]
Current back pain intensity before and after each session, assessed on a numerical pain rating scale from 0 to 10.
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.
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.
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]

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)?
End of intervention period [Day 28]
Overall patient satisfaction with the LumbaCure® intervention
Time Frame: End of intervention period [Day 28]

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)?
End of intervention period [Day 28]
Risk of falling
Time Frame: Between baseline and the end of the investigation,visit 3 [Day 28]
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.
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
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.
Between the end of the investigation,visit 3 [Day 28] and one month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of the device
Time Frame: through study completion, one month
The number, intensity and severity of adverse events are reported before each LumbaCure session.
through study completion, one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIV-23-09-043961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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