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

NCT04701073 | Completed

• 2 other identifiers: EC332020-003201-54
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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

Conditions

Low Back Pain

Keywords

Low back pain; Lumbar belt; Functional capacity; Medicoeconomic; Compliance

Outcome Measures

Primary Outcomes (1)

• Change from baseline ODI score (Oswestry Disability Index) at 12 weeks

  The functional capacity is measured by ODI score.The ODI questionnaire consists in 10 questions and 6 answers modalities.The ODI score results are expressed in percentage.The higher the percentage is, the more the functional capacity is impaired.

  Week: 0 and 12

Secondary Outcomes (15)

• Evolution of functional capacity

  Week: 0 and 4

• Evolution of pain level

  Week: 0, 4 and 12

• Evolution of pain characteristics

  Week: 0, 4 and 12

• Evolution of Quality of Life

  Week: 0 and 12

• Assessment of doctors' opinion on improving the patient's health condition caused by low back pain and severity

  Week 0, 4 and 12

Study Arms (2)

Control group "usual care"

NO INTERVENTION

Promotion of physical activity and taking usual medicines for pain relief

Intervention group : lumbar belt

EXPERIMENTAL

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

Device: LombaStab belt

Interventions

LombaStab belt 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.

Intervention group : lumbar belt

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• Thuasne: lead
• RCTs: collaborator

Study Sites (3)

CHU Grenoble Alpes

Grenoble, France

Location

Hôpital Cochin

Paris, France

Location

CHU de St Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Low Back Pain; Patient Compliance

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Laurent GRANGE, MD, PH

  CHU de Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An interventional, prospective, multicenter, randomized, open and controlled study

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 8, 2021
• Study Start: February 1, 2021
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)