Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
NCT ID: NCT05706103
Last Updated: 2025-03-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
62 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-04
Study Completion Date
2025-12-31
Brief Summary
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Exercise therapy has been shown to be effective in decreasing pain and improving function for patients with recurrent low back pain (LBP). Research on the mechanisms that trigger and/or underlie the effects of exercise therapy on LBP problems is of critical importance for the prevention of recurring or persistence of this costly and common condition. One factor that seems to be crucial within this context is the dysfunction of the back muscles. Recent pioneering results have shown that individuals with recurring episodes of LBP have specific dysfunctions of these muscles (peripheral changes) and also dysfunctions at the cortical level (central changes). This work provides the foundation to take a fresh look at the interplay between peripheral and central aspects, and its potential involvement in exercise therapy. The current project will draw on this opportunity to address the following research questions: What are the immediate (after a single session) and the long-term effects (after 18 repeated sessions) of exercise training on: (1) back muscle structure; (2) back muscle function; (3) the structure of the brain; (4) and functional connectivity of the brain. This research project also aims to examine whether the effects are dependent on how the training was performed. Therefore a specific versus a general exercise program will be compared.
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Detailed Description
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Although the cause of persistent non-specific LBP remains unknown, structural and functional alterations of the brain and paravertebral muscles have been proposed as underlying mechanisms. As it is hypothesized that these alterations contribute to, or maintain non-specific LBP, exercise therapy is a key element in the rehabilitation of reoccurring LBP. Specific training of sensorimotor control of the lumbopelvic region (i.e. specific skilled motor training) has shown to decrease pain and disability in patients with LBP, but has not been found superior to other forms of exercise training regarding improvements in clinical outcome measures. On the other hand, this type of training seems to differentially impact the recruitment of the back muscles compared to general exercise training. However, research using multiple treatment sessions and including follow-up outcome assessments is scarce. Furthermore, it is unknown if improvements may be attributed to measurable peripheral changes in the muscle and/or central neural adaptations in the brain. The primary aim of this study is to examine the short and long-term effects of specific skilled motor control training versus unspecific general extension training on pain, functional disability, brain structure/function and muscle structure/function in recurrent LBP patients.
Method: In this double-blind, randomized controlled clinical trial 62 recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training (i.e. the experimental group) or general extension training (i.e. control group). Each training group will receive 13 weeks of treatment, during which a total of 18 supervised treatment sessions will be delivered in combination with an individualized home-exercise program. Both groups will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18). Primary outcome measures include: LBP-related pain and disability (RMDQ, NRS and Margolis pain diagram), lumbar muscle structure and function (Dixon MRI and mf-MRI) and brain structure and function (MRI, DTI and fMRI). Secondary measures include: lumbopelvic control and proprioception (thoracolumbar dissociation test and position-reposition test), trunk muscle activity (RAM and QFRT) and psychosocial factors, including measures of physical activity (IPAQ-LF, SF-36), pain cognitions and perceptions (PCS, PCI and PVAQ), anxiety and depression (HADS), and kinesiophobia (TSK). Experimental data collection will be performed at baseline, immediately following the low-load training (i.e. after the 9th supervised treatment session), following the high-load training (i.e. after the 18th supervised treatment session), and at 3 months follow-up. Experimental data collection will comprise of magnetic resonance imaging of the brain and trunk muscles, clinical assessments assessing muscle function, and a battery of questionnaires evaluating psychosocial factors.
Method: In this double-blind, randomized controlled clinical trial 62 recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training (i.e. the experimental group) or general extension training (i.e. control group). Each training group will receive 13 weeks of treatment, during which a total of 18 supervised treatment sessions will be delivered in combination with an individualized home-exercise program. Both groups will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18). Primary outcome measures include: LBP-related pain and disability (RMDQ, NRS and Margolis pain diagram), lumbar muscle structure and function (Dixon MRI and mf-MRI) and brain structure and function (MRI, DTI and fMRI). Secondary measures include: lumbopelvic control and proprioception (thoracolumbar dissociation test and position-reposition test), trunk muscle activity (RAM and QFRT) and psychosocial factors, including measures of physical activity (IPAQ-LF, SF-36), pain cognitions and perceptions (PCS, PCI and PVAQ), anxiety and depression (HADS), and kinesiophobia (TSK). Experimental data collection will be performed at baseline, immediately following the low-load training (i.e. after the 9th supervised treatment session), following the high-load training (i.e. after the 18th supervised treatment session), and at 3 months follow-up. Experimental data collection will comprise of magnetic resonance imaging of the brain and trunk muscles, clinical assessments assessing muscle function, and a battery of questionnaires evaluating psychosocial factors.
Conditions
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Low Back Pain, Recurrent
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The study model is parallel. Participants experiencing recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training or general extension training (i.e. parallel study model). Both groups will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18) (i.e. cross-over study model).
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Specific skilled motor training
13 weeks of treatment, with 18 supervised treatment sessions in combination with an individualized home-exercise program. This group will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18).
Group Type
EXPERIMENTAL
Specific skilled motor training
Intervention Type
BEHAVIORAL
Participants allocated to the skilled motor training group will receive sensorimotor training of the intrinsic muscles of the lumbopelvic region, namely the multifidus, transversus abdominis, and pelvic floor muscles.
General extension training
13 weeks of treatment, with 18 supervised treatment sessions in combination with an individualized home-exercise program. This group will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18).
Group Type
ACTIVE_COMPARATOR
General extension training
Intervention Type
BEHAVIORAL
Participants allocated to the general extension training group will receive general training exercises using the David Back equipment from the Back Unit at Ghent University Hospital
Interventions
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Specific skilled motor training
Participants allocated to the skilled motor training group will receive sensorimotor training of the intrinsic muscles of the lumbopelvic region, namely the multifidus, transversus abdominis, and pelvic floor muscles.
Intervention Type
BEHAVIORAL
General extension training
Participants allocated to the general extension training group will receive general training exercises using the David Back equipment from the Back Unit at Ghent University Hospital
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* History of non-specific recurrent LBP with the first onset being at least 6 months ago
* At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
* Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
* During remission the NRS intensity for LBP should be 0.
* LBP should be of that severity that it limits activities of daily living
* LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints
* Flexion pattern of LBP
* At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
* Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
* During remission the NRS intensity for LBP should be 0.
* LBP should be of that severity that it limits activities of daily living
* LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints
* Flexion pattern of LBP
Exclusion Criteria
* Chronic LBP (i.e. duration remission \<1 month)
* Subacute LBP (i.e. first onset between 3 and 6 months ago)
* Acute (i.e. first onset \<3 months ago) LBP
* Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy)
* Patients with neuropathic pain
* Patients with chronic widespread pain as defined by the criteria of the 1990 ACR (i.e. fibromyalgia)
* A lifetime history of spinal traumata (e.g. whiplash), surgery (e.g. laminectomy) or deformations (e.g. scoliosis)
* A lifetime history of respiratory, metabolic, neurologic, cardiovascular, inflammatory, orthopedic or rheumatologic diseases
* Concomitant therapies (i.e. rehabilitation, alternative medicine or therapies)
* Contra-indications for MRI (e.g. suffering from claustrophobia, the presence of metallic foreign material in the body, BMI \>30kg/m²)
* Professional athletes
* Pregnant women
* Breastfeeding women
* Women given birth in the last year before enrolment
* Subacute LBP (i.e. first onset between 3 and 6 months ago)
* Acute (i.e. first onset \<3 months ago) LBP
* Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy)
* Patients with neuropathic pain
* Patients with chronic widespread pain as defined by the criteria of the 1990 ACR (i.e. fibromyalgia)
* A lifetime history of spinal traumata (e.g. whiplash), surgery (e.g. laminectomy) or deformations (e.g. scoliosis)
* A lifetime history of respiratory, metabolic, neurologic, cardiovascular, inflammatory, orthopedic or rheumatologic diseases
* Concomitant therapies (i.e. rehabilitation, alternative medicine or therapies)
* Contra-indications for MRI (e.g. suffering from claustrophobia, the presence of metallic foreign material in the body, BMI \>30kg/m²)
* Professional athletes
* Pregnant women
* Breastfeeding women
* Women given birth in the last year before enrolment
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fund for Scientific Research, Flanders, Belgium
OTHER
Sponsor Role
collaborator
University Ghent
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jessica van Oosterwijck, Prof
Role: STUDY_DIRECTOR
Ghent University, Pain in Motion
Locations
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Ghent University, vakgroep revalidatiewetenschappen
Ghent, Oost-Vlaanderen, Belgium
Site Status
RECRUITING
Countries
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Belgium
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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U1111-1283-4631
Identifier Type: REGISTRY
Identifier Source: secondary_id
BC-05152
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
NA
COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
NCT04715789
UNKNOWN
NA
An Exercise Program in Patients With Chronic Low Back Pain
NCT05524129
COMPLETED
NA
Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
NCT05780021
RECRUITING
NA
Sensorimotor Training in Low-back Pain Rehabilitation
NCT02304120
COMPLETED
NA
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention
NCT02398760
COMPLETED
NA
Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
NCT02103036
UNKNOWN
NA
Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk
NCT02837653
COMPLETED
NA
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
NCT00256373
UNKNOWN
PHASE3
Effects of Different Kinds of Exercise in Low Back Pain
NCT06330961
COMPLETED
NA
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
NCT02633917
COMPLETED
NA
Optimize Low Back Pain
NCT03859713
UNKNOWN
PHASE3
Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
NCT02221609
COMPLETED
NA
Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
NCT03200509
UNKNOWN
NA
Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
NCT01556581
COMPLETED
NA