Clinical trial NCT04701073: Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Lumbar belt
Functional capacity
Medicoeconomic
Compliance
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: RCTs
First posted: 2021-01-08
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional, prospective, multicenter, randomized, open and controlled study
Primary purpose: TREATMENT

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 back pain. This trial is also designed to provide quality of life data and to assess the medico-economic interest of wearing such a lumbar belt.

This is an interventional study with low risks and constraints that does not deviate from the local standard of care for enrolled patients. No invasive examination or procedure is performed; as such, there will be no additional risks for participating patients.

203 patients will be followed during 12 weeks in up to 20 investigational sites Patients meeting all eligibility criteria will be included in the study and randomized into one of the two following groups on a 1: 1 ratio.

* Control group "usual care": promotion of physical activity and taking usual medicines for pain relief
* Intervention group: wearing the LombaStab belt in addition to usual care (promotion of physical activity and taking usual medicines for pain relief).

Three visits will be performed:

* Inclusion visit - baseline D0 - V0
* Follow-up visit at week 4 (+/- 5 days) - V1
* Follow-up visit at week 12 (+/- 5 days) - V2

At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, low back pain history, medical and surgical history, concomitant medications.

At each visit will be performed:

* physical examinations and score assessment by the investigator: ODI score, finger-to-floor distance test, Schober Mac Rae test
* medical interview with patient in order to collect the following information: description of pain, drug consumption, duration of sick leave and resumption of activity at work, use of medical resources (consultations and complementary).
* reporting of all AEs and device deficiencies

Patients will be asked to complete on-line questionnaires, following visits and each week.

Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Change from baseline ODI score (Oswestry Disability Index) at 12 weeks
timeFrame: Week: 0 and 12
Secondary outcomes:
measure: Evolution of functional capacity
timeFrame: Week: 0 and 4
measure: Evolution of pain level
timeFrame: Week: 0, 4 and 12
measure: Evolution of pain characteristics
timeFrame: Week: 0, 4 and 12
measure: Evolution of Quality of Life
timeFrame: Week: 0 and 12
measure: Assessment of doctors' opinion on improving the patient's health condition caused by low back pain and severity
timeFrame: Week 0, 4 and 12
measure: Assessment of patient's opinion on Global Impression of Change about his general condition
timeFrame: Week: 4 and 12
measure: Evolution of spinal mobility vie Finger to floor distance test
timeFrame: Week: 0, 4 and 12
measure: Evolution of spinal mobility via Schober Mac Rae test
timeFrame: Week: 0, 4 and 12
measure: Evolution of physical activity
timeFrame: Week: 0, 4 and 12
measure: Evolution of drug consumption
timeFrame: Week: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
measure: Medical and paramedical consultations
timeFrame: Week: 0, 4 and 12
measure: Duration of Sick leave
timeFrame: Week: 0, 4 and 12
measure: Assessment of tolerance
timeFrame: Week: 4 and 12
measure: Assessment of time of belt's wearing
timeFrame: through study completion, an average of 12 weeks
measure: Assessment of patient's satisfaction about the lumbar belt comfort and design
timeFrame: Week 12
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Paris
country: France
facility: Hôpital Cochin
city: Saint-Étienne
country: France
facility: CHU de St Etienne
Study officials:
affiliation: CHU de Grenoble Alpes
name: Laurent GRANGE, MD, PH
role: PRINCIPAL_INVESTIGATOR
References: