Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
- Conditions
- Low Back Pain, Recurrent
- Interventions
- Behavioral: General extension trainingBehavioral: Specific skilled motor training
- Registration Number
- NCT05706103
- Lead Sponsor
- University Ghent
- Brief 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 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General extension training 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). Specific skilled motor training 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).
- Primary Outcome Measures
Name Time Method Brain macro-structure At 3 months follow-up Whole brain T1-weighted structural MRI will be acquired.
Brain micro-structure At 3 months follow-up Whole-brain T2-weighted images will be obtained.
- Secondary Outcome Measures
Name Time Method Lumbopelvic proprioception At 3 months follow-up. To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.
Anxiety and depression At 3 months follow-up Hospital Anxiety and depression scale (HADS)
Functional brain connectivity At 3 months follow-up Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.
Lumbar muscle function At 3 months follow-up. T2-weighted mf-MRI will be conducted.
Lumbopelvic control At 3 months follow-up. 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.
Pain vigilance and awareness At 3 months follow-up Pain vigilance and awareness questionnaire (PVAQ)
Pain catastrophizing At 3 months follow-up Pain Catastrophizing Scale (PCS)
Compensatory postural adjustments At 3 months follow-up 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).
Nociceptive flexion reflex - threshold At 3 months follow-up 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.
Conditioned pain modulation At 3 months follow-up 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.
Health status At 3 months follow-up Short Form Health Survey-36 items (SF-36)
Low back pain related disability At 3 months follow-up The Roland Morris Disability Questionnaire will be used to evaluate disability.
Lumbar muscle structure At 3 months follow-up T1-weighted Dixon MRI will be performed.
Nociceptive flexion reflex - temporal summation At 3 months follow-up 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.
Physical activity At 3 months follow-up. International physical activity questionnaire - long form (IPAQ-LF)
Pain coping At 3 months follow-up Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)
Kinesiophobia At 3 months follow-up Tampa Scale for Kinesiophobia (TSK)
Low back pain related pain At 3 months follow-up LBP related pain intensity will be evaluated by using an 11 point NRS
Anticipatory postural adjustments At 3 months follow-up 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).
Low back pain recurrence At 12 months follow-up 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.
Trial Locations
- Locations (1)
Ghent University, vakgroep revalidatiewetenschappen
🇧🇪Ghent, Oost-Vlaanderen, Belgium