Lumbar Belt Benefit Compared to the Usual Care in the Treatment of Non-specific Low Back Pain

NCT ID: NCT04701073

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-06-20

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group "usual care"

Promotion of physical activity and taking usual medicines for pain relief

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group : lumbar belt

wearing the LombaStab belt during 3 months in addition to usual care (promotion of physical activity and taking usual medicines for pain relief).

Group Type: EXPERIMENTAL

LombaStab belt

Intervention Type: DEVICE

Instruction given to the patient will be to wear the LombaStab belt from 4 to 8 hours per days, over the whole duration of the study (12 weeks). The investigator will explain to the patient how to adjust it.

The LombaStab belt will be equiped with thermosensor to evaluate the belt wearing time at the end of the study.

Interventions

LombaStab belt

Instruction given to the patient will be to wear the LombaStab belt from 4 to 8 hours per days, over the whole duration of the study (12 weeks). The investigator will explain to the patient how to adjust it.

The LombaStab belt will be equiped with thermosensor to evaluate the belt wearing time at the end of the study.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RCTs

INDUSTRY

Sponsor Role: collaborator

Thuasne

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent GRANGE, MD, PH

Role: PRINCIPAL_INVESTIGATOR

CHU de Grenoble Alpes

Locations

CHU Grenoble Alpes

Grenoble, , France

Hôpital Cochin

Paris, , France

CHU de St Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2020-003201-54

Identifier Type: REGISTRY

Identifier Source: secondary_id

EC33

Identifier Type: -

Identifier Source: org_study_id