Status:
COMPLETED
Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain
Lead Sponsor:
Thuasne
Collaborating Sponsors:
RCTs
Conditions:
Low Back Pain
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Lumbar belt benefit compared to the usual care in the treatment of non-specific low back pain -an interventional, prospective, multicenter, randomized, open and controlled.study
Detailed Description
This is a controlled study, with randomization of the patients, which aims at evaluating the benefit and interest of wearing a new generation lumbar belt, in patients suffering from non-specific low b...
Eligibility Criteria
Inclusion
- Male or female, aged from 18 to 55 years old
- Patient suffering from non-specific low back pain with current episode has progressed for 1 to 6 months
- At least one lumbar mean pain at rest or at effort of the last 72 hours collected on inclusion ≥ 40/100 on an NRS scale.
- Ability of the patient or legally authorized representative to provide a signed and dated i informed consent form before any procedure or data collection.
- Patient covered by the French Social security system.
Exclusion
- Patient wearing a lumbar belt the day of the inclusion visit
- Patient who has had surgical intervention on dorso-lumbar spine or lower limb the past 5 years or who has planned surgery during the study
- MODIC diagnosis (disc degeneration) known or confirmed by MRI
- On sick leave for more than 3 consecutive months due to low back pain at the time of inclusion
- Low back pain related to an accident at work
- Low back pain due to secondary origin: tumor, inflammatory, infectious cause, related to a fracture or a vertebral compression
- Patient with fibromyalgia
- Patient with lumbar radicular syndrome (radicular conflict like disc herniation, spinal stenosis...)
- Pregnant woman or trying to become pregnant during the study
- Patient with confirmed depression
- Patient with cognitive or mental disorders
- Morphology with measurements not allowing to match with the sizes of belts available
- Patient presenting chronic pathology with disabling functional consequences
- Patient who received an infiltration less than one month before inclusion visit or planned during the study
- Patient with known allergy to any of the materials (see product composition in the Description section of user instruction)
- Patient with contraindicated to belt wearing: hiatus hernia, deficient respiratory functions
- Anticipated poor compliance of subject with study procedures
- Current participation in an interventional investigation drug or device treatment study with an impact on evaluation criteria
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04701073
Start Date
February 1 2021
End Date
June 20 2024
Last Update
September 5 2024
Active Locations (3)
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1
CHU Grenoble Alpes
Grenoble, France
2
Hôpital Cochin
Paris, France
3
CHU de St Etienne
Saint-Etienne, France