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NCT Number: NCT05706103

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

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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Key information

Conditions

Low Back Pain, Recurrent Back Pain Behavior Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Brain macro-structure

    Time frame: Baseline

    Whole brain T1-weighted structural MRI will be acquired.

  2. Brain macro-structure

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

    Whole brain T1-weighted structural MRI will be acquired.

  3. Brain macro-structure

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

    Whole brain T1-weighted structural MRI will be acquired.

  4. Brain macro-structure

    Time frame: At 3 months follow-up

    Whole brain T1-weighted structural MRI will be acquired.

  5. Brain micro-structure

    Time frame: Baseline

    Whole-brain T2-weighted images will be obtained.

  6. Brain micro-structure

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

    Whole-brain T2-weighted images will be obtained.

  7. Brain micro-structure

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

    Whole-brain T2-weighted images will be obtained.

  8. Brain micro-structure

    Time frame: At 3 months follow-up

    Whole-brain T2-weighted images will be obtained.

Secondary outcomes

  1. Functional brain connectivity

    Time frame: Baseline

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

  2. Functional brain connectivity

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

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

  3. Functional brain connectivity

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

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

  4. Functional brain connectivity

    Time frame: At 3 months follow-up

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

  5. Lumbar muscle structure

    Time frame: Baseline

    T1-weighted Dixon MRI will be performed.

  6. Lumbar muscle structure

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

    T1-weighted Dixon MRI will be performed.

  7. Lumbar muscle structure

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

    T1-weighted Dixon MRI will be performed.

  8. Lumbar muscle structure

    Time frame: At 3 months follow-up

    T1-weighted Dixon MRI will be performed.

  9. Lumbar muscle function

    Time frame: Baseline

    T2-weighted mf-MRI will be conducted.

  10. Lumbar muscle function

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

    T2-weighted mf-MRI will be conducted.

  11. Lumbar muscle function

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

    T2-weighted mf-MRI will be conducted.

  12. Lumbar muscle function

    Time frame: At 3 months follow-up.

    T2-weighted mf-MRI will be conducted.

  13. Lumbopelvic control

    Time frame: Baseline

    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.

  14. Lumbopelvic control

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

    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.

  15. Lumbopelvic control

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

    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.

  16. Lumbopelvic control

    Time frame: 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.

  17. Lumbopelvic proprioception

    Time frame: Baseline

    To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.

  18. Lumbopelvic proprioception

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

    To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.

  19. Lumbopelvic proprioception

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

    To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.

  20. Lumbopelvic proprioception

    Time frame: At 3 months follow-up.

    To evaluate lumbar proprioception, the position-reposition accuracy of the lumbar spine will be determined.

  21. Anticipatory postural adjustments

    Time frame: Baseline

    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).

  22. Anticipatory postural adjustments

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

    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).

  23. Anticipatory postural adjustments

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

    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).

  24. Anticipatory postural adjustments

    Time frame: 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).

  25. Compensatory postural adjustments

    Time frame: Baseline

    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).

  26. Compensatory postural adjustments

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

    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).

  27. Compensatory postural adjustments

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

    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).

  28. Compensatory postural adjustments

    Time frame: 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).

  29. Nociceptive flexion reflex - threshold

    Time frame: Baseline

    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.

  30. Nociceptive flexion reflex - threshold

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

    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.

  31. Nociceptive flexion reflex - threshold

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

    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.

  32. Nociceptive flexion reflex - threshold

    Time frame: 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.

  33. Nociceptive flexion reflex - temporal summation

    Time frame: Baseline

    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.

  34. Nociceptive flexion reflex - temporal summation

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

    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.

  35. Nociceptive flexion reflex - temporal summation

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

    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.

  36. Nociceptive flexion reflex - temporal summation

    Time frame: 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.

  37. Conditioned pain modulation

    Time frame: Baseline

    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.

  38. Conditioned pain modulation

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

    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.

  39. Conditioned pain modulation

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

    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.

  40. Conditioned pain modulation

    Time frame: 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.

  41. Anxiety and depression

    Time frame: Baseline

    Hospital Anxiety and depression scale (HADS)

  42. Anxiety and depression

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

    Hospital Anxiety and depression scale (HADS)

  43. Anxiety and depression

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

    Hospital Anxiety and depression scale (HADS)

  44. Anxiety and depression

    Time frame: At 3 months follow-up

    Hospital Anxiety and depression scale (HADS)

  45. Physical activity

    Time frame: Baseline

    International physical activity questionnaire - long form (IPAQ-LF)

  46. Physical activity

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

    International physical activity questionnaire - long form (IPAQ-LF)

  47. Physical activity

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

    International physical activity questionnaire - long form (IPAQ-LF)

  48. Physical activity

    Time frame: At 3 months follow-up.

    International physical activity questionnaire - long form (IPAQ-LF)

  49. Pain coping

    Time frame: Baseline

    Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)

  50. Pain coping

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

    Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)

  51. Pain coping

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

    Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)

  52. Pain coping

    Time frame: At 3 months follow-up

    Pain coping inventory (PCI), Pain Catastrophizing Scale (PCS)

  53. Pain catastrophizing

    Time frame: Baseline

    Pain Catastrophizing Scale (PCS)

  54. Pain catastrophizing

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

    Pain Catastrophizing Scale (PCS)

  55. Pain catastrophizing

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

    Pain Catastrophizing Scale (PCS)

  56. Pain catastrophizing

    Time frame: At 3 months follow-up

    Pain Catastrophizing Scale (PCS)

  57. Pain vigilance and awareness

    Time frame: Baseline

    Pain vigilance and awareness questionnaire (PVAQ)

  58. Pain vigilance and awareness

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

    Pain vigilance and awareness questionnaire (PVAQ)

  59. Pain vigilance and awareness

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

    Pain vigilance and awareness questionnaire (PVAQ)

  60. Pain vigilance and awareness

    Time frame: At 3 months follow-up

    Pain vigilance and awareness questionnaire (PVAQ)

  61. Kinesiophobia

    Time frame: Baseline

    Tampa Scale for Kinesiophobia (TSK)

  62. Kinesiophobia

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

    Tampa Scale for Kinesiophobia (TSK)

  63. Kinesiophobia

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

    Tampa Scale for Kinesiophobia (TSK)

  64. Kinesiophobia

    Time frame: At 3 months follow-up

    Tampa Scale for Kinesiophobia (TSK)

  65. Health status

    Time frame: Baseline

    Short Form Health Survey-36 items (SF-36)

  66. Health status

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

    Short Form Health Survey-36 items (SF-36)

  67. Health status

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

    Short Form Health Survey-36 items (SF-36)

  68. Health status

    Time frame: At 3 months follow-up

    Short Form Health Survey-36 items (SF-36)

  69. Low back pain related pain

    Time frame: Baseline

    LBP related pain intensity will be evaluated by using an 11 point NRS

  70. Low back pain related pain

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

    LBP related pain intensity will be evaluated by using an 11 point NRS

  71. Low back pain related pain

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

    LBP related pain intensity will be evaluated by using an 11 point NRS

  72. Low back pain related pain

    Time frame: At 3 months follow-up

    LBP related pain intensity will be evaluated by using an 11 point NRS

  73. Low back pain related disability

    Time frame: Baseline

    The Roland Morris Disability Questionnaire will be used to evaluate disability.

  74. Low back pain related disability

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

    The Roland Morris Disability Questionnaire will be used to evaluate disability.

  75. Low back pain related disability

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

    The Roland Morris Disability Questionnaire will be used to evaluate disability.

  76. Low back pain related disability

    Time frame: At 3 months follow-up

    The Roland Morris Disability Questionnaire will be used to evaluate disability.

  77. Low back pain recurrence

    Time frame: At 6 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.

  78. Low back pain recurrence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica van Oosterwijck, Prof

CONTACT

[email protected]

+3293326919

Lieven Danneels, Prof

CONTACT

[email protected]

+32 9 332 26 35

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Official study title

Efficacy of Specific Skilled Motor Versus General Exercise Training on Peripheral Muscle and Central Brain Alterations in Patients with Recurrent Low Back Pain

Acronym: ExTraS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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