Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Specific skilled motor training

    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

    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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Specific skilled motor trainingExperimental treatment 1 intervention
Group B: General extension trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brain macro-structure

Whole brain T1-weighted structural MRI will be acquired.

Time frame
Baseline
2

Brain macro-structure

Whole brain T1-weighted structural MRI will be acquired.

Time frame
After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
3

Brain macro-structure

Whole brain T1-weighted structural MRI will be acquired.

Time frame
After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
4

Brain macro-structure

Whole brain T1-weighted structural MRI will be acquired.

Time frame
At 3 months follow-up

Secondary outcomes

1

Functional brain connectivity

Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.

Time frame
Baseline
2

Functional brain connectivity

Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.

Time frame
After low-load training phase (i.e. after 9th supervised treatment session) assessed at approximately 8 weeks
3

Functional brain connectivity

Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.

Time frame
After high-load training phase (i.e. after 18th supervised treatment session) assessed at approximately 13 weeks
4

Functional brain connectivity

Resting-state functional MRI will be performed to acquire insight into subnetworks relating to sensorimotor control and pain processing.

Time frame
At 3 months follow-up

Other outcomes

Sponsors and contacts

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University Ghent

Lead sponsor

Fund for Scientific Research, Flanders, Belgium

Collaborator