Phase
Condition
Chronic Pain
Treatment
LombaStab belt
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, aged from 18 to 55 years old
Patient suffering from non-specific low back pain with current episode hasprogressed for 1 to 6 months
At least one lumbar mean pain at rest or at effort of the last 72 hours collected oninclusion ≥ 40/100 on an NRS scale.
Ability of the patient or legally authorized representative to provide a signed anddated i informed consent form before any procedure or data collection.
Patient covered by the French Social security system.
Exclusion
Exclusion Criteria:
Patient wearing a lumbar belt the day of the inclusion visit
Patient who has had surgical intervention on dorso-lumbar spine or lower limb thepast 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 ofinclusion
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 orplanned during the study
Patient with known allergy to any of the materials (see product composition in theDescription section of user instruction)
Patient with contraindicated to belt wearing: hiatus hernia, deficient respiratoryfunctions
Anticipated poor compliance of subject with study procedures
Current participation in an interventional investigation drug or device treatmentstudy with an impact on evaluation criteria
Study Design
Study Description
Connect with a study center
CHU Grenoble Alpes
Grenoble,
FranceSite Not Available
Hôpital Cochin
Paris,
FranceSite Not Available
CHU de St Etienne
Saint-Étienne,
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.