Common Non-specific Low Back PainMIRACLENCT07111286
Impact of Motor Imagery in the Functional Rehabilitation of Patients With Chronic Low Back Pain: a Randomised Controlled Trial
A study testing Assessment, Motor imagery task sessions and Cognitive task sessions in people with Common Non-specific Low Back Pain, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Non-specific low back pain (NSLBP) is a very common condition and one of the leading causes of disability worldwide. It has a significant impact on quality of life, with functional, locomotor and psychological repercussions, and is often associated with kinesiophobia (excessive fear of movement due to apprehension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Non-specific Low Back Pain
- What is being tested?
- Assessment, Motor imagery task sessions and Cognitive task sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Person who has given their verbal consent
- Suffering from chronic non-specific low back pain that has been ongoing for more than 6 months
- Eligible for a multimodal rehabilitation programme according to the investigating physician
Who cannot join
- Persons not affiliated with or not covered by a social security scheme
- Patients subject to legal protection measures (guardianship, curatorship)
- Patients subject to judicial protection measures
- Pregnant women, women in labour or breastfeeding women
- Adults who are incapacitated or unable to give their consent
- Patients with a history of repeated falls
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- Scheduled lumbar spine surgery in the coming year
- Associated conditions other than spinal conditions (orthopaedic, neurological, vascular, cardiac, etc.) that could significantly impair mobility
- Radicular involvement (sciatica or cruralgia) with motor deficit < 3 in the lower limbs
- Impaired comprehension skills making self-assessment impossible
- Patients with poorly controlled epilepsy
- Individuals who are not fluent in English
- Patients who have already completed a multimodal rehabilitation programme in a specialised centre
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Mathieu GUEUGNON, 03 80 29 35 71, mathieu.gueugnon@chu-dijon.fr
About this study
Non-specific low back pain (NSLBP) is a very common condition and one of the leading causes of disability worldwide. It has a significant impact on quality of life, with functional, locomotor and psychological repercussions, and is often associated with kinesiophobia (excessive fear of movement due to apprehension related to pain or injury). For the most severe cases, multidisciplinary rehabilitation programmes are recommended. The objectives are, on the one hand, to offer reconditioning to exercise and, on the other hand, to educate, raise awareness about physical activity and help combat fears in order to reduce symptoms, improve quality of life and re-engage in daily and professional activities. However, these programmes are not entirely effective, and many of you still live with chronic lower back pain.
To improve the management of lower back pain, it is important to understand how the body functions with this condition, particularly when there is chronic pain. It has been shown that people suffering from lower back pain often have difficulty controlling their movements. This means that their brain is less able to prepare certain movements. One method that can help improve movement preparation and control is motor imagery (MI). This involves imagining a movement without physically performing it. This technique activates the same areas of the brain as when the movement is performed. This is why it can be beneficial and help improve treatment.
Read more
This research will evaluate the effectiveness of an innovative rehabilitation programme incorporating motor imagery (MI) in patients with chronic low back pain. MI could improve motor skills at the end of rehabilitation as well as quality of life. Conversely, the inability to perform certain movements, kinesiophobia and pain could be reduced.
Each participant will follow the REAGIR multimodal rehabilitation programme at the Dijon Bourgogne University Hospital (7 hours of rehabilitation per day, 5 days per week for 3 weeks, consisting of activities such as: personalised whole-body exercises (aerobic) on ergometers; resistance training, balneotherapy, therapeutic education, individual and group motivational interviews, nutritional advice, relaxation sessions and psychology sessions). By participating in this study, patients will benefit from this programme as well as 30-minute motor imagery sessions, the content of which will depend on the experimental group to which they are assigned after randomisation.
Participation will also include a visit before the start and after the end of the programme in order to carry out various assessments.
- Conditions
- Common Non-specific Low Back Pain
- Being tested
- Assessment, Motor imagery task sessions, Cognitive task sessions, Assessment of satisfaction and tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Before and after the programme :
- Self-questionnaires: assessment of pain (visual analogue scale), functional disability (Oswestry), kinesiophobia (Tampa scale of Kinesiophobia), mood (Hospital Anxiety Depression Scale), quality of life (SF12), level of physical activity (Simple Physical Activity Questionnaire), and level of motor imagery (Kinesthesic and Visual Imagery Questionnaire-10)
- Functional tests: Sorensen test, Shirado test, Time Up and Go test (TUG), 6-minute walk test, 200-metre fast walk test, measurement of maximum isometric strength of back extensors/flexors, 3D analysis of locomotion, posture and trunk flexion.
- Evaluation of excitability and inhibition mechanisms within the primary motor cortex at rest and during motor imagery using single and double pulse TMS. Excitability between the brain and the erector spinae muscles and inhibition of the primary motor cortex will be measured at rest and during imagery of back flexion and extension movements
Motor imagery task sessionsOther
3 sessions of 30 minutes per week
Cognitive task sessionsOther
3 sessions of 30 minutes per week
Assessment of satisfaction and toleranceOther
During the final assessment, which will take place after the programme. Satisfaction and tolerance will be assessed using a visual analogue scale.
| Study group | Role | What they receive |
|---|---|---|
| Group with motor imagery | Experimental | Not described Receives: Other: Assessment; Other: Motor imagery task sessions; Other: Assessment of satisfaction and tolerance |
| Control | Active comparator | Not described Receives: Other: Assessment; Other: Cognitive task sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration in seconds during the functional endurance test of the trunk extensors (Sorensen test)
Measured: At baseline (Month 1) and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start22 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111286
- Sponsor's protocol ID
- GUEUGNON CRBFC 2023
- Acronym
- MIRACLE
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Motor Imagery in the Functional Rehabilitation of Patients With Chronic Low Back Pain: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07111286
- Acronym / sponsor ID
- MIRACLE / GUEUGNON CRBFC 2023
- Conditions
- Common Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Aug 2025 (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.
Non-specific low back pain (NSLBP) is a very common condition and one of the leading causes of disability worldwide. It has a significant impact on quality of life, with functional, locomotor and psychological repercussions, and is often associated with kinesiophobia (excessive fear of movement due to apprehension related to pain or injury). For the most severe cases, multidisciplinary rehabilitation programmes are recommended. The objectives are, on the one hand, to offer reconditioning to exercise and, on the other hand, to educate, raise awareness about physical activity and help combat fears in order to reduce symptoms, improve quality of life and re-engage in daily and professional activities. However, these programmes are not entirely effective, and many of you still live with chronic lower back pain.
To improve the management of lower back pain, it is important to understand how the body functions with this condition, particularly when there is chronic pain. It has been shown that people suffering from lower back pain often have difficulty controlling their movements. This means that their brain is less able to prepare certain movements. One method that can help improve movement preparation and control is motor imagery (MI). This involves imagining a movement without physically performing it. This technique activates the same areas of the brain as when the movement is performed. This is why it can be beneficial and help improve treatment.
This research will evaluate the effectiveness of an innovative rehabilitation programme incorporating motor imagery (MI) in patients with chronic low back pain. MI could improve motor skills at the end of rehabilitation as well as quality of life. Conversely, the inability to perform certain movements, kinesiophobia and pain could be reduced.
Each participant will follow the REAGIR multimodal rehabilitation programme at the Dijon Bourgogne University Hospital (7 hours of rehabilitation per day, 5 days per week for 3 weeks, consisting of activities such as: personalised whole-body exercises (aerobic) on ergometers; resistance training, balneotherapy, therapeutic education, individual and group motivational interviews, nutritional advice, relaxation sessions and psychology sessions). By participating in this study, patients will benefit from this programme as well as 30-minute motor imagery sessions, the content of which will depend on the experimental group to which they are assigned after randomisation.
Participation will also include a visit before the start and after the end of the programme in order to carry out various assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with motor imagery | Experimental | Other: Assessment, Other: Motor imagery task sessions, Other: Assessment of satisfaction and tolerance |
| Control | Active comparator | Other: Assessment, Other: Cognitive task sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Person who has given their verbal consent
- Suffering from chronic non-specific low back pain that has been ongoing for more than 6 months
- Eligible for a multimodal rehabilitation programme according to the investigating physician
Key exclusion criteria (13 listed)
- Persons not affiliated with or not covered by a social security scheme
- Patients subject to legal protection measures (guardianship, curatorship)
- Patients subject to judicial protection measures
- Pregnant women, women in labour or breastfeeding women
- Adults who are incapacitated or unable to give their consent
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 |
|---|---|---|
| AssessmentBefore and after the programme : * Self-questionnaires: assessment of pain (visual analogue scale), functional disability (Oswestry), kinesiophobia (Tampa scale of Kinesiophobia), mood (Hospital Anxiety Depression Scale), quality of life (SF12), level of physical activity (Simple Physical Activity Questionnaire), and level of motor imagery (Kinesthesic and Visual Imagery Questionnaire-10) * Functional tests: Sorensen test, Shirado test, Time Up and Go test (TUG), 6-minute walk test, 200-metre fast walk test, measurement of maximum isometric strength of back extensors/flexors, 3D analysis of locomotion, posture and trunk flexion. * Evaluation of excitability and inhibition mechanisms within the primary motor cortex at rest and during motor imagery using single and double pulse TMS. Excitability between the brain and the erector spinae muscles and inhibition of the primary motor cortex will be measured at rest and during imagery of back flexion and extension movements | Other | Control, Group with motor imagery |
| Motor imagery task sessions3 sessions of 30 minutes per week | Other | Group with motor imagery |
| Cognitive task sessions3 sessions of 30 minutes per week | Other | Control |
| Assessment of satisfaction and toleranceDuring the final assessment, which will take place after the programme. Satisfaction and tolerance will be assessed using a visual analogue scale. | Other | Group with motor imagery |
Primary outcome
Duration in seconds during the functional endurance test of the trunk extensors (Sorensen test)
Time frame: At baseline (Month 1) and Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment, Motor imagery task sessions and Cognitive task sessions in people with Common Non-specific Low Back Pain, run by Centre Hospitalier Universitaire Dijon 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 13 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie BIZE (03 80 29 57 38, sophie.bize@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration in seconds during the functional endurance test of the trunk extensors (Sorensen test) (time frame: At baseline (Month 1) and 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 27 Jan 2026.