Low Back Pain, RecurrentExTraSNCT05706103
Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
A study testing Specific skilled motor training and General extension training in people with Low Back Pain, Recurrent, run by University Ghent at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Specific skilled motor training and General extension training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jan 2021to 31 Dec 2025
- Phase
- Interventional
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University, vakgroep revalidatiewetenschappen
Ghent, Oost-Vlaanderen, 9000
Jessica van Oosterwijck, Prof, +32 9 332 69 19, Jessica.VanOosterwijck@UGent.be
Jaap Wijnen, Msc, +32 9 332 12 16, jaap.wijnen@ugent.be
About this study
Official title: Efficacy of Specific Skilled Motor Versus General Exercise Training on Peripheral Muscle and Central Brain Alterations in Patients with Recurrent Low Back Pain
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Recurrent
- Being tested
- Specific skilled motor training, General extension training
- Keywords
- low back pain, motor control, exercise, randomized controlled trial
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific skilled motor trainingBehavioural
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 trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Specific skilled motor training | Experimental | 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). Receives: Behavioral: Specific skilled motor training |
| General extension training | Active comparator | 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). Receives: Behavioral: General extension training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain macro-structure
Whole brain T1-weighted structural MRI will be acquired.
Measured: Baseline
Brain macro-structure
Whole brain T1-weighted structural MRI will be acquired.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Brain macro-structure
Whole brain T1-weighted structural MRI will be acquired.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Brain macro-structure
Whole brain T1-weighted structural MRI will be acquired.
Measured: At 3 months follow-up
Brain micro-structure
Whole-brain T2-weighted images will be obtained.
Measured: Baseline
Brain micro-structure
Whole-brain T2-weighted images will be obtained.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Brain micro-structure
Whole-brain T2-weighted images will be obtained.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Brain micro-structure
Whole-brain T2-weighted images will be obtained.
Measured: At 3 months follow-up
Secondary outcomes (78)
Functional brain connectivity
Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.
Measured: Baseline
Functional brain connectivity
Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Functional brain connectivity
Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Functional brain connectivity
Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.
Measured: At 3 months follow-up
Lumbar muscle structure
T1-weighted Dixon MRI will be performed.
Measured: Baseline
Lumbar muscle structure
T1-weighted Dixon MRI will be performed.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Lumbar muscle structure
T1-weighted Dixon MRI will be performed.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Lumbar muscle structure
T1-weighted Dixon MRI will be performed.
Measured: At 3 months follow-up
Lumbar muscle function
T2-weighted mf-MRI will be conducted.
Measured: Baseline
Lumbar muscle function
T2-weighted mf-MRI will be conducted.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Lumbar muscle function
T2-weighted mf-MRI will be conducted.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Lumbar muscle function
T2-weighted mf-MRI will be conducted.
Measured: At 3 months follow-up.
Lumbopelvic control
Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction.
Measured: Baseline
Lumbopelvic control
Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Lumbopelvic control
Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Lumbopelvic control
Lumbopelvic control will be examined by means of a clinical thoracolumbar dissociation test which assesses the quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction.
Measured: At 3 months follow-up.
Lumbopelvic proprioception
To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.
Measured: Baseline
Lumbopelvic proprioception
To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Lumbopelvic proprioception
To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Lumbopelvic proprioception
To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.
Measured: At 3 months follow-up.
Anticipatory postural adjustments
To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM).
Measured: Baseline
Anticipatory postural adjustments
To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM).
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Anticipatory postural adjustments
To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM).
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Anticipatory postural adjustments
To examine anticipatory postural adjustments (APAs) trunk muscle onset latencies in response to internal-induced perturbations will be measured by means of surface electromyography (EMG). APAs will be measured by inducing internal perturbations in the trunk muscles during a reliable and valid unilateral rapid arm movement task (RAM).
Measured: At 3 months follow-up
Compensatory postural adjustments
To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT).
Measured: Baseline
Compensatory postural adjustments
To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT).
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Compensatory postural adjustments
To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT).
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Compensatory postural adjustments
To examine compensatory postural adjustments (CPAs), trunk muscle onset latencies in response to external-induced perturbations will be measured by means of surface electromyography (EMG). CPAs will be measured by using external perturbations of trunk muscles during a quick-force-release test (QFRT).
Measured: At 3 months follow-up
Nociceptive flexion reflex - threshold
The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris.
Measured: Baseline
Nociceptive flexion reflex - threshold
The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Nociceptive flexion reflex - threshold
The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Nociceptive flexion reflex - threshold
The NFR will be elicited in the dominant leg by transcutaneous electrical stimulation of the sural nerve in its retromalleolar path using a stimulation bar electrode connected to a constant current stimulator. Surface EMG electrodes will be placed on the skin of the muscle belly of the ipsilateral biceps femoris.
Measured: At 3 months follow-up
Nociceptive flexion reflex - temporal summation
Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times.
Measured: Baseline
Nociceptive flexion reflex - temporal summation
Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Nociceptive flexion reflex - temporal summation
Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Nociceptive flexion reflex - temporal summation
Five 1ms rectangular wave pulse train will be administered 3 times at a frequency of 2 Hz at a constant stimulation intensity. This procedure will be repeated 5 times.
Measured: At 3 months follow-up
Conditioned pain modulation
The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side.
Measured: Baseline
Conditioned pain modulation
The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Conditioned pain modulation
The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Conditioned pain modulation
The conditioning stimulus will comprise of immersion of the non-dominant hand until the proximal wrist crease in a hot circulating water bath of 45.5°C during 6 minutes. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) during and after completion of the conditioning stimulus. Before, after 2 min of immersion and 2 minutes after completion of immersion, the test stimulus will be repeated twice at each test location at the dominant body side.
Measured: At 3 months follow-up
Anxiety and depression
Hospital Anxiety and depression scale (HADS)
Measured: Baseline
Anxiety and depression
Hospital Anxiety and depression scale (HADS)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Anxiety and depression
Hospital Anxiety and depression scale (HADS)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Anxiety and depression
Hospital Anxiety and depression scale (HADS)
Measured: At 3 months follow-up
Physical activity
International physical activity questionnaire - long form (IPAQ-LF)
Measured: Baseline
Physical activity
International physical activity questionnaire - long form (IPAQ-LF)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Physical activity
International physical activity questionnaire - long form (IPAQ-LF)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Physical activity
International physical activity questionnaire - long form (IPAQ-LF)
Measured: At 3 months follow-up.
Pain coping
Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)
Measured: Baseline
Pain coping
Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Pain coping
Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Pain coping
Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)
Measured: At 3 months follow-up
Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Measured: Baseline
Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Measured: At 3 months follow-up
Pain vigilance and awareness
Pain vigilance and awareness questionnaire (PVAQ)
Measured: Baseline
Pain vigilance and awareness
Pain vigilance and awareness questionnaire (PVAQ)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Pain vigilance and awareness
Pain vigilance and awareness questionnaire (PVAQ)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Pain vigilance and awareness
Pain vigilance and awareness questionnaire (PVAQ)
Measured: At 3 months follow-up
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK)
Measured: Baseline
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK)
Measured: At 3 months follow-up
Health status
Short Form Health Survey-36 items (SF-36)
Measured: Baseline
Health status
Short Form Health Survey-36 items (SF-36)
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Health status
Short Form Health Survey-36 items (SF-36)
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Health status
Short Form Health Survey-36 items (SF-36)
Measured: At 3 months follow-up
Low back pain related pain
LBP related pain intensity will be evaluated by using an 11 point NRS
Measured: Baseline
Low back pain related pain
LBP related pain intensity will be evaluated by using an 11 point NRS
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Low back pain related pain
LBP related pain intensity will be evaluated by using an 11 point NRS
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Low back pain related pain
LBP related pain intensity will be evaluated by using an 11 point NRS
Measured: At 3 months follow-up
Low back pain related disability
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Measured: Baseline
Low back pain related disability
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Measured: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
Low back pain related disability
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Measured: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
Low back pain related disability
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Measured: At 3 months follow-up
Low back pain recurrence
Self-report via telephone interview: (1) the number of episode(s), (2) the duration of the LBP episode(s), (3) pain intensity, measured with three NRS for average-, worst- and current pain during the LBP episode(s), (4) location and quality of pain (i.e. sharp, burning, etc. sensation), (5) subjects opinion about what caused the new episode of LBP, (6) degree of impairments in daily life activities due to the LBP, (7) whether participants sought treatment (i.e. physiotherapist, general practitioner, etc.) and (8) strategies to cope with the new LBP episode.
Measured: At 6 months follow-up
Low back pain recurrence
Self-report via telephone interview: (1) the number of episode(s), (2) the duration of the LBP episode(s), (3) pain intensity, measured with three NRS for average-, worst- and current pain during the LBP episode(s), (4) location and quality of pain (i.e. sharp, burning, etc. sensation), (5) subjects opinion about what caused the new episode of LBP, (6) degree of impairments in daily life activities due to the LBP, (7) whether participants sought treatment (i.e. physiotherapist, general practitioner, etc.) and (8) strategies to cope with the new LBP episode.
Measured: At 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start4 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- 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
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Jessica van Oosterwijck, Prof, Study director, Ghent University, Pain in Motion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706103
- Sponsor's protocol ID
- BC-05152
- Other IDs
- U1111-1283-4631
- Acronym
- ExTraS
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
PubMed 29480409Deyo RA. Diagnostic evaluation of LBP: reaching a specific diagnosis is often impossible. Arch Intern Med. 2002 Jul 8;162(13):1444-7; discussion 1447-8. doi: 10.1001/archinte.162.13.1444. No abstract available.
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