NCT04701073

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2021-01-08
• Last updated: 2024-09-05

Locations

3 sites across 1 country: France