Effect of Pain Science Education Combined With Graded Exposure to Movement on Physiological Stress Responses and Motor Performance in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 主要终点
- Pain Intensity
研究概览
简要总结
Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. This clinical trial will evaluate whether a 6-week program combining pain science education with graded exposure to movement is more effective than usual physical therapy for adults with chronic low back pain.
Participants will be randomly assigned to one of two groups: pain science education combined with graded exposure to movement, or usual physical therapy. The study will assess changes in pain, disability, fear of movement, and pain-related thoughts. It will also examine physiological responses to stress and muscle activity while participants perform a lifting task.
The study aims to determine whether combining education about pain with gradual exposure to feared movements can improve clinical outcomes, physiological responses to stress, and motor performance in people with chronic low back pain.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 60 years.
- •Diagnosis of chronic low back pain, defined as low back pain occurring every day for at least 3 months or on at least half of the days during the previous 6 -months.
- •Willingness to participate in the study.
排除标准
- •Body mass index >30 kg/m².
- •Inability to understand study instructions.
- •Neurological conditions affecting the central nervous system (e.g., stroke or spinal cord injury).
- •Pregnancy.
- •Currently receiving alternative therapies.
- •Previous participation in a pain education program.
- •History of trauma or orthopedic surgery within the previous 12 months.
研究组 & 干预措施
Pain Science Education Plus Graded Exposure
Participants will receive a 6-week program combining pain science education with graded exposure to movement. Pain science education will be delivered once weekly through a hybrid format, including group, individual online, and asynchronous sessions. Participants will also receive one individual, in-person graded exposure session per week for 6 weeks. Graded exposure will be individualized according to activities that participants fear or avoid, with progressive modification of load, speed, or range of motion.
干预措施: Pain Science Education Plus Graded Exposure (Behavioral)
Usual Physical Therapy
Participants will receive usual physical therapy for 6 weeks. The intervention will include one group-based educational session on low back pain and one in-person physical therapy session per week for 6 weeks. Physical therapy will include stretching, thermotherapy, electrotherapy, and conventional core stabilization exercises. Participants will also be instructed to perform trunk stabilization exercises at home three days per week.
干预措施: Usual Physical Therapy (Other)
结局指标
主要结局
Pain Intensity
时间窗: Baseline and immediately after the 6-week intervention
Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm ("no pain") to 100 mm ("worst pain imaginable"). Higher scores indicate greater pain intensity.
Low Back Pain-Related Disability
时间窗: Baseline and immediately after the 6-week intervention
Disability will be assessed using the validated Spanish version of the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 items scored as 0 or 1, resulting in a total score ranging from 0 to 24. Higher scores indicate greater low back pain-related disability.
次要结局
- Heart Rate Variability(Baseline and immediately after the 6-week intervention)
- Skin Conductance(Baseline and immediately after the 6-week intervention)
- Trunk Muscle Co-contraction During the Lifting Task(Baseline and immediately after the 6-week intervention)
- Kinesiophobia(Baseline and immediately after the 6-week intervention)
- Task-Specific Fear(Baseline and immediately after the 6-week intervention)
- Pain Catastrophizing(Baseline and immediately after the 6-week intervention)
- Intolerance of Uncertainty(Baseline and immediately after the 6-week intervention)
研究者
RODRIGO NUNEZ
Principal Investigator
University of Chile