Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes (DICO)

NCT ID: NCT04191161

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-09-15

Brief Summary

Chronic low back pain may be associated with active discopathy. This subset of individuals are defined by a clinical and radiological syndrome with specific MRI signals, known as MODIC changes.

Three types (I, II and III) of MODIC changes are described. Type I refers to the inflammatory reaction regarding the intervertebral-disc subchondral bone and adjacent vertebral-endplate subchondral bone. The natural evolution of this active discopathy will lead to sclerosis (type III) supposedly less painful. So far the underlying mechanism remains unclear and debated (mechanical, local infection, genetic). In the absence of international guidelines on the management on chronic low back pain with MC type 1, different therapeutic strategies have been described. The main goal is to accelerate the transition to MC type 2, which is supposedly less painful. The estimated time to expect a transition from type 1 to type 2 is at least 1 year.

The mechanical hypothesis found its origin in the Modic et al. initial study, linking Modic changes (MC) types 1 and 2 to degenerative disc disease.

The Histological analysis of patient suffering from active discopathy has shown signs of micro fractures regarding vertebral endplates. The local inflammatory reaction may be part of a repair process following the micro fracture. Based on this mechanical explanation an orthopaedic treatment with a lumbar brace may accelerate the healing, thus the transition from modic I to type II. This approach has been studied in a retrospective analysis on 62 patients suffering from active discopathy (modic type I) who were prescribed a custom lumbar rigid brace for 3 months, at endpoint 80% of the patients treated described a reduction of at least 30% of their initial pain.

This study aims to confirm the previous hypothesis, that lumbar immobilisation by custom rigid brace can reduce the pain after being worn for 3 months. Secondary objective will be to assess the pain reduction at 6 months along with functional outcome, fears and beliefs, mood and medical costs at short (3 months) and mid (6months) term.

Detailed Description

This will be a 2 parallel group multicentre randomised controlled trial. Patients will undergo 3 consultations with the physician, based on the usual follow up for this pathology. During the first consultation the physician will check the inclusion criteria, medical history, clinical data relative to the different outcomes, and prescribe optimizated pain killers and deliver information about self care and physical activity. Patient reported outcome measures will be assessed through self answering questionnaires with the help of a research assistant if necessary. After randomisation the prosthetist will take the measurement to conceive the custom brace. Patients will then be re-examined during a 2nd consultation 3 month later to assess the main outcome (pain reduction) and other secondary outcome (proms). A third consultation will be organised 6 months later for secondary outcome (pain reduction and proms).

Conditions

Chronic Pain

Study Design

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

Study Groups

Brace group

patients will receive their brace 2 weeks after the first consultation (usual delay to conceive and deliver the brace), they will be asked to wear the brace all day and will be allowed to redraw it at night. Brace must be worn for 3 months. A specific eduction on how to wear the brace will also be delivered. A thermal sensor chip will be placed in the brace to assess the observance. No physiotherapy will be prescribed during this period. Patient will attend to 3 consultations, day 0, 3 months and finally at 6 months later. These three consultations are part of usual care.

Group Type: EXPERIMENTAL

Wearing the rigid brace

Intervention Type: DEVICE

Custom braces are made from 4mm thick polyethylene with Velcro® fastening. They are Computer Aided Designed and are made by the same manufacturer (LAGARRIGUE). A thermal sensor chip will placed in the brace to assess observance.

Control group

patients will continue physiotherapy sessions if already prescribed but no extra sessions will be prescribed. Pain killers will be adjusted. Patients will also attend to three consultations such as described above. Main outcome will be assessed at M3. After M3, patients who did not receive the brace will have the choice to receive it for the next 3 months and secondary outcome will be assessed at 6 months.

Group Type: PLACEBO_COMPARATOR

Wearing the rigid brace

Intervention Type: DEVICE

Custom braces are made from 4mm thick polyethylene with Velcro® fastening. They are Computer Aided Designed and are made by the same manufacturer (LAGARRIGUE). A thermal sensor chip will placed in the brace to assess observance.

Interventions

Wearing the rigid brace

Custom braces are made from 4mm thick polyethylene with Velcro® fastening. They are Computer Aided Designed and are made by the same manufacturer (LAGARRIGUE). A thermal sensor chip will placed in the brace to assess observance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-- Age: > 18 years < 55 years

• Patient affiliated to a social security scheme ( beneficiary entitled )
• Patient has given its consent in writing to participate in the study
• Low back pain associated with a MODIC I signal at the lumbar stage objectified by an MRI dated less than 6 months and confirmed by a radiologist.

Exclusion Criteria

• Other types of Modic change
• Other cause of back pain such as spondylolisthesis, fracture, spondylitis, scoliosis, rheumatoid arthritis and also
• Patient not willing to wear the brace for at least 3 months
• Pregnancy

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

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Coudeyre

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2019-A00861-56

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 COUDEYRE

Identifier Type: -

Identifier Source: org_study_id