Chronic PainDICONCT04191161
Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes (DICO)
A study testing Wearing the rigid brace in people with Chronic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Wearing the rigid brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes
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.
Read more
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.
Read the 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
- Being tested
- Wearing the rigid brace
- Keywords
- Modic type I, Chronic low back pain, Rigid brace
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing the rigid braceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wearing the rigid brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 3
Secondary outcomes (10)
The Roland Morris Disability Questionnaire measures in patients with low back pain
The Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Roland and Morris did not provide descriptions of the varying degrees of disability (eg, 40%-60% is severe disability). Clinical improvement over time can be graded based on the analysis of serial questionnaire scores. If, for example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement
Measured: Month 3
The Roland Morris Disability Questionnaire measures in patients with low back pain
The Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Roland and Morris did not provide descriptions of the varying degrees of disability (eg, 40%-60% is severe disability). Clinical improvement over time can be graded based on the analysis of serial questionnaire scores. If, for example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement
Measured: Month 6
The fears and beliefs measured by questionnaire FABQ
The FABQ can help predict those that have a high pain avoidance behavior. Clinically, these people may need to be supervised more than those that confront their pain. The FABQ contains 2 scales: a work scale (FABQ-W) composed of 7 items and a physical activity scale (FABQ-PA) composed of 4 items. The two scales are scored separately. Higher FABQ scores indicate elevated fear-avoidance beliefs. "FABQ-W" has a point score that ranges from 0-42 points. It can be calculated as follows: (Total points for items 6, 7, 9, 10 11, 12 and 15) = Work scale score. "FABQ-PA" can range from 0-24 points. Scores are calculated as follows: (Total points for items 2, 3, 4 and 5) = Physical activity scale score.
Measured: Month 3
The fears and beliefs measured by questionnaire FABQ
The FABQ can help predict those that have a high pain avoidance behavior. Clinically, these people may need to be supervised more than those that confront their pain. The FABQ contains 2 scales: a work scale (FABQ-W) composed of 7 items and a physical activity scale (FABQ-PA) composed of 4 items. The two scales are scored separately. Higher FABQ scores indicate elevated fear-avoidance beliefs. "FABQ-W" has a point score that ranges from 0-42 points. It can be calculated as follows: (Total points for items 6, 7, 9, 10 11, 12 and 15) = Work scale score. "FABQ-PA" can range from 0-24 points. Scores are calculated as follows: (Total points for items 2, 3, 4 and 5) = Physical activity scale score.
Measured: Month 6
The knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression)
The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
- One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
- Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
Measured: Month 3
The knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression)
The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
- One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
- Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
Measured: Month 6
Patient Global Impression of Change by Scale PGIC
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item. Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.
Measured: Month 3
Patient Global Impression of Change by Scale PGIC
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item. Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.
Measured: Month 6
patient preference towards the treatment received
question asked by investigator to patient
Measured: day 0
medical costs
social security expenses such brace price, number of physiotherapy sessions, sick leave duration, pharmacologic treatment, consultations linked to chronic low back pain (general practitioner or specialist) and complementary examination (MRI, CT scans, radiography, blood analysis)
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start12 Apr 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Coudeyre, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191161
- Sponsor's protocol ID
- RBHP 2019 COUDEYRE
- Other IDs
- 2019-A00861-56
- Acronym
- DICO
- Status last verified
- Sep 2022
- First submitted
- 6 Dec 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lumbar Immobilisation by Rigid Brace for Chronic Low Back Pain Patients With Modic 1 Changes
- ClinicalTrials.gov ID
- NCT04191161
- Acronym / sponsor ID
- DICO / RBHP 2019 COUDEYRE
- Conditions
- Chronic Pain
- Keywords
- Modic type I, Chronic low back pain, Rigid brace
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brace group | Experimental | Device: Wearing the rigid bracepatients 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. |
| Control group | Placebo comparator | Device: Wearing the rigid bracepatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- -- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing the rigid braceCustom 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. | Device | Brace group, Control group |
Primary outcome
Reduction of the pain intensity
Time frame: Month 3
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)
10 secondary outcomes
The Roland Morris Disability Questionnaire measures in patients with low back pain
Time frame: Month 3
The Roland Morris Disability Questionnaire measures in patients with low back pain
Time frame: Month 6
The fears and beliefs measured by questionnaire FABQ
Time frame: Month 3
The fears and beliefs measured by questionnaire FABQ
Time frame: Month 6
The knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression)
Time frame: Month 3
The knowledge of emotional state measured by questionnaire HAD (Hospital Anxiety and Depression)
Time frame: Month 6
Patient Global Impression of Change by Scale PGIC
Time frame: Month 3
Patient Global Impression of Change by Scale PGIC
Time frame: Month 6
patient preference towards the treatment received
Time frame: day 0
medical costs
Time frame: month 3
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Coudeyre principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing the rigid brace in people with Chronic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the pain intensity (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.