Studies

Observational Recruiting

NCT05851196 on ClinicalTrials.gov

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

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

  • Sponsor: Hasselt University
  • Collaborators: KU Leuven
  • Enrollment: 100 (Estimated)
  • Study start: 2024-01-15 (Actual)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2027-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Low Back Pain
  • Back Pain Lower Back Chronic

Intervention / Treatment

  • Other: Proprioceptive training

Primary Outcome Measures

  • Proprioceptive postural control at baseline 1 (t= 0 weeks) (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.
  • Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients) (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.
  • Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients) (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.
  • Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients) (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.
  • Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients) (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.
  • Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls) (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.
  • Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients) (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.
  • Macroscopic characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients) (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.
  • Macroscopic characteristisc of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients) (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.
  • Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls) (At t= 0 weeks)
    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
  • Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients) (At baseline 2 (t= 8 weeks))
    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
  • Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients) (After 16 weeks of training (t= 24 weeks))
    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
  • Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients) (16 weeks after the end of training (t= 40 weeks))
    Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
  • Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 1 (t= 0 weeks) (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).
  • Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients) (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).
  • Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 8 weeks of training (t= 16 weeks) (only for patients) (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).
  • Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients) (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).
  • Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients) (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).
  • Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 1 (t= 0 weeks) (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).
  • Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 2 (t= 8 weeks) (only for patients) (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).
  • Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 8 weeks of training (t= 16 weeks) (only for patients) (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).
  • Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 16 weeks of training (t= 24 weeks) (only for patients) (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).
  • Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae 16 weeks after the end of training (t= 40 weeks) (only for patients) (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).

Countries

Belgium

Locations and Investigators

  • REVAL Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium (Recruiting)
    • Lotte Janssens, PhD
    • Nina Goossens, PhD
    • Lotte Janssens, PhD (Principal Investigator)
    • Nina Goossens, PhD
    • Frank Vandenabeele, PhD
    • Anouk Agten, PhD
  • Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium (Recruiting)
    • Simon Brumagne, PhD
    • Vasiliki Karagiannopoulou, MSc
    • Simon Brumagne, PhD (Principal Investigator)
    • Lieven Moke, PhD
    • Kaat Desloovere, PhD
    • Zafeiris Louvaris, PhD
    • Vasiliki Karagiannopoulou, MSc

Study Officials