Status:
TERMINATED
Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.
Lead Sponsor:
Odix
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading ca...
Eligibility Criteria
Inclusion
- Chronic non-specific LBP (without red flag)
- Patient did not increase, on a long-term basis, his/her regular physical activity in the past 2 months.
- LBP is the principal musculoskeletal condition
- Aged between 18 and 65 years old
- Able to read and understand questionnaires and communicate with the physiotherapist.
- Average Back Pain intensity over the last week above 2, assessed on Numerical Pain Rating Scale from 0 to 10 anchored with "no pain" at 0 and "worst pain imaginable " at 10.
- ODI score \> 20
Exclusion
- Suspected or confirmed serious pathology (i.e infection, fracture, cancer, inflammatory arthritis, ….)
- Radicular pain
- Radiculopathy
- Cognitive impairment that precludes participant from consenting, completing investigation questionnaires or complying with recommendations
- Previous spine surgery in the last 3 months
- Pregnant women
- body weight \> 120 kg
- Neurological disease
- Fibromyalgia
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06138002
Start Date
October 2 2023
End Date
September 12 2024
Last Update
October 18 2024
Active Locations (2)
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1
Jessa Ziekenhuis vzw
Hasselt, Belgium, 3500
2
Jessa Ziekenhuis vzw
Herk-de-Stad, Belgium, 3540