Impact of Motor Imagery in the Functional Rehabilitation of Patients With Chronic Low Back Pain: a Randomised Controlled Trial
MIRACLE
1 other identifier
interventional
72
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedStudy Start
First participant enrolled
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
January 27, 2026
January 1, 2026
2.1 years
July 31, 2025
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Duration in seconds during the functional endurance test of the trunk extensors (Sorensen test)
At baseline (Month 1) and Month 3
Study Arms (2)
Group with motor imagery
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
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
During the final assessment, which will take place after the programme. Satisfaction and tolerance will be assessed using a visual analogue scale.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2025
First Posted
August 8, 2025
Study Start
January 22, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
January 27, 2026
Record last verified: 2026-01