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
- Lotte Janssens, PhD (Principal Investigator) — Hasselt University