NCT07111286

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress14%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

July 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

July 31, 2025

Last Update Submit

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

EXPERIMENTAL
Other: AssessmentOther: Motor imagery task sessionsOther: Assessment of satisfaction and tolerance

Control

ACTIVE COMPARATOR
Other: AssessmentOther: Cognitive task sessions

Interventions

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

ControlGroup with motor imagery

3 sessions of 30 minutes per week

Group with motor imagery

3 sessions of 30 minutes per week

Control

During the final assessment, which will take place after the programme. Satisfaction and tolerance will be assessed using a visual analogue scale.

Group with motor imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Interventions

Restraint, PhysicalDrug Tolerance

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesPharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

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

Locations