Clinical trial NCT05706103: Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Recurrent
Keywords: low back pain
motor control
exercise
randomized controlled trial
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2023-01-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Brain macro-structure
timeFrame: Baseline
measure: Brain macro-structure
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Brain macro-structure
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Brain macro-structure
timeFrame: At 3 months follow-up
measure: Brain micro-structure
timeFrame: Baseline
measure: Brain micro-structure
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Brain micro-structure
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Brain micro-structure
timeFrame: At 3 months follow-up
Secondary outcomes:
measure: Functional brain connectivity
timeFrame: Baseline
measure: Functional brain connectivity
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Functional brain connectivity
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Functional brain connectivity
timeFrame: At 3 months follow-up
measure: Lumbar muscle structure
timeFrame: Baseline
measure: Lumbar muscle structure
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Lumbar muscle structure
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Lumbar muscle structure
timeFrame: At 3 months follow-up
measure: Lumbar muscle function
timeFrame: Baseline
measure: Lumbar muscle function
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Lumbar muscle function
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Lumbar muscle function
timeFrame: At 3 months follow-up.
measure: Lumbopelvic control
timeFrame: Baseline
measure: Lumbopelvic control
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Lumbopelvic control
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Lumbopelvic control
timeFrame: At 3 months follow-up.
measure: Lumbopelvic proprioception
timeFrame: Baseline
measure: Lumbopelvic proprioception
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Lumbopelvic proprioception
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Lumbopelvic proprioception
timeFrame: At 3 months follow-up.
measure: Anticipatory postural adjustments
timeFrame: Baseline
measure: Anticipatory postural adjustments
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Anticipatory postural adjustments
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Anticipatory postural adjustments
timeFrame: At 3 months follow-up
measure: Compensatory postural adjustments
timeFrame: Baseline
measure: Compensatory postural adjustments
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Compensatory postural adjustments
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Compensatory postural adjustments
timeFrame: At 3 months follow-up
measure: Nociceptive flexion reflex - threshold
timeFrame: Baseline
measure: Nociceptive flexion reflex - threshold
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Nociceptive flexion reflex - threshold
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Nociceptive flexion reflex - threshold
timeFrame: At 3 months follow-up
measure: Nociceptive flexion reflex - temporal summation
timeFrame: Baseline
measure: Nociceptive flexion reflex - temporal summation
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Nociceptive flexion reflex - temporal summation
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Nociceptive flexion reflex - temporal summation
timeFrame: At 3 months follow-up
measure: Conditioned pain modulation
timeFrame: Baseline
measure: Conditioned pain modulation
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Conditioned pain modulation
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Conditioned pain modulation
timeFrame: At 3 months follow-up
measure: Anxiety and depression
timeFrame: Baseline
measure: Anxiety and depression
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Anxiety and depression
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Anxiety and depression
timeFrame: At 3 months follow-up
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Physical activity
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Physical activity
timeFrame: At 3 months follow-up.
measure: Pain coping
timeFrame: Baseline
measure: Pain coping
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Pain coping
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Pain coping
timeFrame: At 3 months follow-up
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Pain catastrophizing
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Pain catastrophizing
timeFrame: At 3 months follow-up
measure: Pain vigilance and awareness
timeFrame: Baseline
measure: Pain vigilance and awareness
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Pain vigilance and awareness
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Pain vigilance and awareness
timeFrame: At 3 months follow-up
measure: Kinesiophobia
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Kinesiophobia
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Kinesiophobia
timeFrame: At 3 months follow-up
measure: Health status
timeFrame: Baseline
measure: Health status
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Health status
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Health status
timeFrame: At 3 months follow-up
measure: Low back pain related pain
timeFrame: Baseline
measure: Low back pain related pain
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Low back pain related pain
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Low back pain related pain
timeFrame: At 3 months follow-up
measure: Low back pain related disability
timeFrame: Baseline
measure: Low back pain related disability
timeFrame: After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
measure: Low back pain related disability
timeFrame: After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
measure: Low back pain related disability
timeFrame: At 3 months follow-up
measure: Low back pain recurrence
timeFrame: At 6 months follow-up
measure: Low back pain recurrence
timeFrame: At 12 months follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, vakgroep revalidatiewetenschappen
state: Oost-Vlaanderen
Study officials:
affiliation: Ghent University, Pain in Motion
name: Jessica van Oosterwijck, Prof
role: STUDY_DIRECTOR
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