The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
- Conditions
- Low Back PainBack Pain Lower Back Chronic
- Interventions
- Other: Proprioceptive training
- Registration Number
- NCT05851196
- Lead Sponsor
- Hasselt University
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with non-specific low back pain Proprioceptive training Individuals with chronic non-specific ow back pain
- Primary Outcome Measures
Name Time Method 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 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 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 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 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.
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.
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).
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.
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.
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 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 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).
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 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).
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.
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).
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).
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 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 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).
- Secondary Outcome Measures
Name Time Method Disability due to low back pain 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.
Pain-related fear of movement 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.
Anxiety and depression 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.
Habitual physical activity 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.
Risk for future work disability due to low back pain 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
Fear-avoidance beliefs about physical activity and work 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.
Pain catastrophizing 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.
Trial Locations
- Locations (2)
REVAL Rehabilitation Research Center, Hasselt University
🇧🇪Diepenbeek, Belgium
Department of Rehabilitation Sciences, KU Leuven
🇧🇪Leuven, Belgium