A Randomized Controlled Trial Comparing Abdominal Expansion and Abdominal Drawing-In Training With Manual and Verbal Cueing in Individuals With Chronic Non-Specific Low Back Pain
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Pain intensity
概览
简要总结
This study aims to investigate the interactive effects of two core stability training strategies-abdominal drawing-in manoeuvre (ADIM) and Dynamic Neuromusculoskeletal Stabilization abdominal expansion (DNS-AE)-and two instructional approaches (verbal cueing and manual facilitation) on training outcomes in individuals with chronic non-specific low back pain.
A 2×2 factorial randomized controlled trial design will be employed. Ninety-six participants with chronic non-specific low back pain will be randomly allocated, using block randomization, to one of four intervention groups in equal proportions. All groups will receive a 4-week intervention program, with training conducted twice per week.
Outcome measures will be assessed at four time points: before the intervention (baseline), immediately after the first training session, at the completion of the 4-week intervention, and at a 3-month follow-up, to evaluate short-term and mid-term effects as well as the sustainability of training outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Clinically diagnosed with chronic non-specific low back pain, with symptoms persisting for more than 12 weeks.
- •Able to understand the study procedures and comply with the full intervention and assessment protocol.
排除标准
- •History of surgery involving the lower back or lower extremities.
- •Presence of neurological symptoms, such as numbness or tingling sensations.
- •Signs or symptoms of nerve root compression.
- •History of any surgical procedure within the past 3 months.
- •Diagnosis of cancer.
- •Presence of major medical or psychiatric disorders.
- •Presence of systemic inflammatory disease.
- •Pregnancy.
- •Structural scoliosis of the spine.
- •Inability to ambulate or stand independently, or other conditions deemed unsuitable for participation.
研究组 & 干预措施
ADIM With Verbal Cueing
Participants receive abdominal drawing-in manoeuvre training with verbal cueing, delivered twice weekly for 4 weeks.
干预措施: Abdominal Drawing-In Manoeuvre Training (Behavioral)
ADIM With Manual Cueing
Participants receive abdominal drawing-in manoeuvre training with manual facilitation, delivered twice weekly for 4 weeks.
干预措施: Abdominal Drawing-In Manoeuvre Training (Behavioral)
DNS-AE With Verbal Cueing
Participants receive Dynamic Neuromusculoskeletal Stabilization abdominal expansion training with verbal cueing, delivered twice weekly for 4 weeks.
干预措施: Dynamic Neuromusculoskeletal Stabilization Abdominal Expansion Training (Behavioral)
DNS-AE With Manual Cueing
Participants receive Dynamic Neuromusculoskeletal Stabilization abdominal expansion training with manual facilitation, delivered twice weekly for 4 weeks.
干预措施: Dynamic Neuromusculoskeletal Stabilization Abdominal Expansion Training (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: At baseline, after the first week of intervention, and at the end of the 4-week intervention.
Pain intensity assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable, with higher scores indicating greater pain intensity.
Movement control performance
时间窗: At baseline, after the first week of intervention, and at the end of the 4-week intervention.
Movement control performance assessed using the Nine-Item Movement Control Test Battery, which evaluates movement quality during standardized functional movement tasks. Each item is scored according to predefined error-based criteria, and item scores are summed to produce a total score ranging from 0 to 93, with higher scores indicating poorer movement control performance.
次要结局
- Pressure pain threshold(At baseline and at the end of the 4-week intervention.)
- Learning acquisition during training(After each training session during the 4-week intervention.)
- Disability related to low back pain(At baseline, at the end of the 4-week intervention, and at 3-month follow-up.)
- Patient-specific functional ability(At baseline, at the end of the 4-week intervention, and at 3-month follow-up.)
- Perceived movement difficulty assessed using the Perceived Difficulty Index (PDI).(At baseline, after the first week of intervention, and at the end of the 4-week intervention.)
- Central sensitization symptoms(At baseline and at the end of the 4-week intervention.)
- Fear-avoidance beliefs(At baseline and at the end of the 4-week intervention.)
- Pain catastrophizing(At baseline and at the end of the 4-week intervention.)
- Global perceived change(At the end of the 4-week intervention and at 3-month follow-up.)
研究者
Wendy Tzyy-Jiuan Wang
Professor, Department of Physical Therapy, National Yang Ming Chiao Tung University
National Yang Ming Chiao Tung University