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NCT Number: NCT05851196

The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.

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Key information

Conditions

Low Back Pain Back Pain Back Pain Lower Back Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

REVAL Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium

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About this study

The Back-to-Back study consists of a cross-sectional study and a proof-of-concept study. The cross-sectional study aims to gain more insight into the peripheral underlying mechanisms of impaired proprioceptive postural control in patients with non-specific low back pain. Macroscopic, microscopic, hemodynamic, and electrophysiological characteristics of the lumbar multifidus and erector spinae muscles will be compared between patients with non-specific low back pain and healthy, age- and sex-matched controls. The interrelatedness between these back muscle characteristics and the correlation with proprioceptive postural control will be examined. The most discriminating muscle characteristics will be determined based upon which phenotypes of patients with non-specific low back pain will be delineated. The proof-of-concept study aims to assess the effects of high-load proprioceptive training on back muscle characteristics and proprioceptive postural control in patients with non-specific low back pain.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients with non-specific low back pain:

  • Aged 18-60 years
  • Non-specific low back pain without radicular leg pain
  • Mechanical low back pain with episodes of <4 on the numerical pain rating scale and episodes of >6 on the numerical pain rating scale
  • Non-specific low back pain for three months or more
  • Score of 20% or more on the Modified Low Back Pain Disability Questionnaire
  • Informed consent to participate

Healthy controls:

  • Aged 18-60 years
  • No history of low back pain needing medical treatment or resulting in a limited activity level
  • No low back pain in the previous six months
  • Informed consent to participate

Exclusion criteria

  • Pregnancy
  • Previous trauma or surgery to the spine, pelvis or lower limbs
  • Structural spinal deformity (e.g., scoliosis)
  • Neurological, neuromuscular, respiratory or systemic disease
  • Central sensitization: score of 50/100 or more on the Central Sensitization Inventory
  • Specific vestibular or balance problems
  • Acute lower limb or neck problems
  • Body mass index of 30 kg/m² or more

Treatment and study plan

Proprioceptive training

Other

A physiotherapist tailors the exercises to the patient's functional demands and pain- or fear-inducing activities. Guided by the therapist, patients look for ways to integrate the exercises into their daily life activities. Each week, patients receive feedback from the physiotherapist, and the training program is gradually progressed. The patients are instructed to perform the exercises daily, integrated into their daily activities, hobbies, and work. The program contains: (1) exercises to improve the sense of posture and movement, (2) exercises to correct the reference frame from which patients control posture and movement, (3) muscle control exercises, (4) exercises to increase variability in postures and movement patterns, (5) functionality: patients search for ways to correct and integrate alternative postures and movement patterns into their daily life, (6) high training frequency and high load, (7) focus on sensing, localizing and differentiating, rather than movement control.

Primary outcomes

  1. Proprioceptive postural control at baseline 1 (t= 0 weeks)

    Time frame: At baseline 1 (t= 0 weeks)

    Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

  2. Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)

    Time frame: At baseline 2 (t= 8 weeks)

    Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

  3. Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)

    Time frame: After 8 weeks of training (t= 16 weeks)

    Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

  4. Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)

    Time frame: After 16 weeks of training (t= 24 weeks)

    Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

  5. Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients)

    Time frame: 16 weeks after the end of training (t= 40 weeks)

    Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

  6. Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)

    Time frame: At t= 0 weeks

    Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.

  7. Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)

    Time frame: At baseline 2 (t= 8w, 2nd baseline)

    Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.

  8. Macroscopic characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)

    Time frame: After 16 weeks of training (t= 24 weeks)

    Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.

  9. Macroscopic characteristisc of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)

    Time frame: 16 weeks after the end of training (t= 40 weeks)

    Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.

  10. Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)

    Time frame: At t= 0 weeks

    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.

  11. Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)

    Time frame: At baseline 2 (t= 8 weeks)

    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.

  12. Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)

    Time frame: After 16 weeks of training (t= 24 weeks)

    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.

  13. Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)

    Time frame: 16 weeks after the end of training (t= 40 weeks)

    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.

  14. Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 1 (t= 0 weeks)

    Time frame: At baseline 1 (t= 0 weeks)

    The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  15. Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)

    Time frame: At baseline 2 (t= 8 weeks)

    The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  16. Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 8 weeks of training (t= 16 weeks) (only for patients)

    Time frame: After 8 weeks of training (t= 16 weeks)

    The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  17. Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)

    Time frame: After 16 weeks of training (t= 24 weeks)

    The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  18. Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)

    Time frame: 16 weeks after the end of training (t= 40 weeks)

    The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  19. Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 1 (t= 0 weeks)

    Time frame: At baseline 1 (t= 0 weeks)

    Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  20. Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 2 (t= 8 weeks) (only for patients)

    Time frame: At baseline 2 (t= 8 weeks)

    Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  21. Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 8 weeks of training (t= 16 weeks) (only for patients)

    Time frame: After 8 weeks of training (t= 16 weeks)

    Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  22. Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 16 weeks of training (t= 24 weeks) (only for patients)

    Time frame: After 16 weeks of training (t= 24 weeks)

    Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

  23. Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae 16 weeks after the end of training (t= 40 weeks) (only for patients)

    Time frame: 16 weeks after the end of training (t= 40 weeks)

    Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).

Secondary outcomes

  1. Disability due to low back pain

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Modified Low Back Pain Disability Questionnaire.

  2. Risk for future work disability due to low back pain

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the short version of the Örebro Musculoskeletal Pain Screening Questionnaire

  3. Pain-related fear of movement

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Tampa Scale for Kinesiophobia.

  4. Fear-avoidance beliefs about physical activity and work

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Fear-Avoidance Beliefs Questionnaire.

  5. Pain catastrophizing

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Pain Catastrophizing Scale.

  6. Anxiety and depression

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Hospital Anxiety and Depression Scale.

  7. Habitual physical activity

    Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

    Participants will be asked to complete the Baecke Questionnaire.

Other outcomes

  1. Age

    Time frame: Immediately after inclusion

    Age (years) will be recorded.

  2. Sex (male/female)

    Time frame: Immediately after inclusion

    Sex will be recorded.

  3. Highest level of education

    Time frame: Immediately after inclusion

    Highest level of education will be recorded.

  4. Current employment status

    Time frame: Immediately after inclusion

    Current employment status will be recorded.

  5. Body weight (kg)

    Time frame: Immediately after inclusion

    Body weight (kg) will be recorded.

  6. Height (cm)

    Time frame: Immediately after inclusion

    Height (cm) will be recorded.

  7. Handedness (left, right)

    Time frame: Immediately after inclusion

    Handedness will be recorded.

  8. Current pain intensity (only for patients)

    Time frame: Immediately after inclusion

    Patients will be asked to rate the current intensity of pain in their lower back (and leg if present) on a Numerical Rating Scale with anchors 0= no pain and 10= worst pain.

  9. Duration of low back pain (only for patients)

    Time frame: Immediately after inclusion

    The duration of low back pain (months) will be recorded.

  10. Medication use (only for patients)

    Time frame: Immediately after inclusion

    Medication use will be recorded.

Study contacts

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

Lotte Janssens, PhD

CONTACT

[email protected]

+3211292174

Simon Brumagne, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • KU Leuven

Registry information

Official study title

Back to Back: the Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

Acronym: Back-to-Back

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 9, 2023
Registry last updated
Feb 28, 2024

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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