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

NCT04191161 | Terminated

• 2 other identifiers: RBHP 2019 COUDEYRE2019-A00861-56
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Modic type I; Chronic low back pain; Rigid brace

Outcome Measures

Primary Outcomes (1)

• Reduction of the pain intensity

  Average change from baseline in the pain intensity measured on a Visual Analogical Scale (VAS) Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

  Month 3

Secondary Outcomes (10)

• The Roland Morris Disability Questionnaire measures in patients with low back pain

  Month 3

• The Roland Morris Disability Questionnaire measures in patients with low back pain

  Month 6

• The fears and beliefs measured by questionnaire FABQ

  Month 3

• The fears and beliefs measured by questionnaire FABQ

  Month 6

• The knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression)

  Month 3

Study Arms (2)

Brace group

EXPERIMENTAL

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.

Device: Wearing the rigid brace

Control group

PLACEBO COMPARATOR

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.

Device: Wearing the rigid brace

Interventions

Wearing the rigid brace 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.

Brace group; Control group

Eligibility Criteria

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

You may qualify if:

• \-- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Coudeyre

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients will be recruited if aged between 18 and 55 years old and suffering from chronic lumbar pain (Visual Analogic Scale (VAS) \> 3) associated with Modic type I changes diagnosed with a MRI achieved less than 6 months before the consultation and interpreted by a radiologist specialised in spine disease. Patients must also be capable of giving a clear consent. Will not be included patients suffering from other types of Modic change, or any 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. Patients will be recruited from the consultation in PMR units across 5 centres in France.

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 9, 2019
• Study Start: April 12, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

FR (1)