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

Primary Purpose

Low Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

LombaStab belt

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Lumbar belt, Functional capacity, Medicoeconomic, Compliance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Grenoble AlpesRecruiting
Hôpital CochinRecruiting
CHU de St EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group "usual care"

Intervention group : lumbar belt

Arm Description

Promotion of physical activity and taking usual medicines for pain relief

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evolution of functional capacity

Evolution of pain level

Pain level is measured by NRS scale completed by the patient : minimum, maximum, mean at effort and at rest : 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)

Evolution of pain characteristics

Characteristics of pain are evaluated by specific questions regarding the description of pain

Evolution of Quality of Life

Quality of life is measured by the EQ5D questionnaire completed by the patient. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using five-level (EQ-5D-5L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).

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

Improvement and severity are measured by the CGI-I and CGI-S questionnaires respectively. Doctors' opinion on the change of patient's health condition due to low back pain is measured by the Clinical Global Impression - Improvement questionnaire. The scale has 7 levels of answer from "very strongly improved" which is the better outcome (= 1 point) to "very strongly aggravated" which is the worst outcome (= 7 points) .Intermediate levels are: " Significantly improved "(= 2 points) ; " Slightly improved " (= 3 points) ; " No improvement " (=4 points) ; " Slightly worsen " (=5 points) ; " Seriously worsen" ( = 6 points). The highest score corresponds to the most impairment in quality of life.

Assessment of patient's opinion on Global Impression of Change about his general condition

Improvement is measured by the PGI-C questionnaire. Patient's opinion on Global Impression of Change about her general condition is measured by the modified PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference.

Evolution of spinal mobility vie Finger to floor distance test

Spinal mobility is measured by finger-to-floor distance test. The subject stands erect on a platform 20-cm high He's asked to bend forward as far as possible, while maintaining the knees, arms, and fingers fully extended. The vertical distance between the tip of the middle finger and the platform is measured with a suppletape measure in centimeters. The vertical distance between the platform and tip of the middle finger is positive when the subject do not reach the platform and negative when he can go further.

Evolution of spinal mobility via Schober Mac Rae test

Spinal mobility is measured by Schober Mac Rae test. The Patient is standing, examiner marks both posterior superior iliac spine and then draws a horizontal line at the centre of both marks. A second line is marked 5 cm below the first line. A third line is marked 10 cm above the first line. Patient is then instructed to flex forward as if attempting to touch his/her toes, examiner remeasures distance between the top and bottom line.

Evolution of physical activity

Physical activity is measured by IPAQ questionnaire completed by the patient The IPAQ questionnaire measures the time associated to intensive activity, moderate activity, walking and sitting in the last week.

Evolution of drug consumption

Drug consumption (analgesics, anti-inflammatories, etc), is recorded by the patient each week in ePRO (name of the drug, frequency of taking the medication)

Medical and paramedical consultations

Number of consultations (physiotherapy / doctors / osteopathy…) or hospitalization and complementary examinations carried out are measured by patient's interview

Duration of Sick leave

Global duration of sick leave (number of days, Saturday and Sunday included) is measured by patient's interview

Assessment of tolerance

Tolerance is measured by adverse events reported. Number and type of serious and non-serious Adverse Device Effects (ADE) are reported..

Assessment of time of belt's wearing

Compliance is measured by a thermosensor specific device fixed to the belt

Assessment of patient's satisfaction about the lumbar belt comfort and design

Satisfaction is measured by a specific questionnaire completed by the patient. Questions are about comfort, easy to use, performance on pain, aesthetic...

Full Information

NCT ID

NCT04701073

First Posted

December 17, 2020

Last Updated

May 2, 2023

Sponsor

Thuasne

Collaborators

RCTs

1. Study Identification

Unique Protocol Identification Number

NCT04701073

Brief Title

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

Acronym

LOMBACT

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thuasne

Collaborators

RCTs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

An interventional, prospective, multicenter, randomized, open and controlled study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

203 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group "usual care"

Arm Type

No Intervention

Arm Description

Promotion of physical activity and taking usual medicines for pain relief

Arm Title

Intervention group : lumbar belt

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

LombaStab belt

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week: 0 and 12

Secondary Outcome Measure Information:

Title

Evolution of functional capacity

Description

Time Frame

Week: 0 and 4

Title

Evolution of pain level

Description

Pain level is measured by NRS scale completed by the patient : minimum, maximum, mean at effort and at rest : 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)

Time Frame

Week: 0, 4 and 12

Title

Evolution of pain characteristics

Description

Characteristics of pain are evaluated by specific questions regarding the description of pain

Time Frame

Week: 0, 4 and 12

Title

Evolution of Quality of Life

Description

Time Frame

Week: 0 and 12

Title

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

Description

Time Frame

Week 0, 4 and 12

Title

Assessment of patient's opinion on Global Impression of Change about his general condition

Description

Time Frame

Week: 4 and 12

Title

Evolution of spinal mobility vie Finger to floor distance test

Description

Time Frame

Week: 0, 4 and 12

Title

Evolution of spinal mobility via Schober Mac Rae test

Description

Time Frame

Week: 0, 4 and 12

Title

Evolution of physical activity

Description

Time Frame

Week: 0, 4 and 12

Title

Evolution of drug consumption

Description

Drug consumption (analgesics, anti-inflammatories, etc), is recorded by the patient each week in ePRO (name of the drug, frequency of taking the medication)

Time Frame

Week: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Title

Medical and paramedical consultations

Description

Number of consultations (physiotherapy / doctors / osteopathy…) or hospitalization and complementary examinations carried out are measured by patient's interview

Time Frame

Week: 0, 4 and 12

Title

Duration of Sick leave

Description

Global duration of sick leave (number of days, Saturday and Sunday included) is measured by patient's interview

Time Frame

Week: 0, 4 and 12

Title

Assessment of tolerance

Description

Tolerance is measured by adverse events reported. Number and type of serious and non-serious Adverse Device Effects (ADE) are reported..

Time Frame

Week: 4 and 12

Title

Assessment of time of belt's wearing

Description

Compliance is measured by a thermosensor specific device fixed to the belt

Time Frame

through study completion, an average of 12 weeks

Title

Assessment of patient's satisfaction about the lumbar belt comfort and design

Description

Satisfaction is measured by a specific questionnaire completed by the patient. Questions are about comfort, easy to use, performance on pain, aesthetic...

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphanie VILLET, Dr

Phone

+33 6 47 78 04 29

stephanie.villet@thuasne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Astrid PICOLET

Phone

+33 6 40 39 24 90

astrid.picolet@thuasne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent GRANGE, MD, PH

Organizational Affiliation

CHU de Grenoble Alpes

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Grenoble Alpes

City

Grenoble

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent Grange, MD, PH

Facility Name

Hôpital Cochin

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François Rannou, MD, PUPH

Facility Name

CHU de St Etienne

City

Saint-Étienne

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Calmels, MD, PUPH

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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