Back to Back: the Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proprioceptive postural control at baseline 1 (t= 0 weeks)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proprioceptive postural control at baseline 1 (t= 0 weeks)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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 16 weeks after the end of training (t= 40 weeks) (only for patients)
时间窗: 16 weeks after the end of training (t= 40 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)
时间窗: 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)
时间窗: 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 baseline 2 (t= 8 weeks) (only for patients)
时间窗: 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)
时间窗: After 16 weeks of training (t= 24 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
研究者
Lotte Janssens
Prof. Dr.
Hasselt University