Phenotyping Chronic Low Back Pain Patients With Central Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Opioid consumption
研究概览
简要总结
By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.
详细描述
Chronic low back pain is a common condition in the world. About 85% of people with low back pain do not know the cause of their pain. This leads to ineffective treatments.
Recently, the idea of an over activated nervous system is thought to be one of the main reasons for chronic pain. Over activated nervous system means pain processing areas in the spine or brain might be more sensitive. Aerobic exercise, such as walking and cycling, is often used to decrease chronic pain. Aerobic exercise is a form of physical exercise that strengthen the heart and lungs in order to improve the body's utilization of oxygen.
The researchers want to examine if aerobic exercise is effective in decreasing over activation of the nervous system. Gaining a better understanding of effects of aerobic exercise on the nervous system may lead to more effective treatments for low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower back pain (LBP) for more than 3 months
- •A minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
- •Can read and understand English.
排除标准
- •Nerve root compression that resulted in numbness or decrease in sensation in the areas for the pain sensitivity tests as reported by the subject
- •cervical or thoracic pain as a main complaint
- •spinal pathologies such as fracture, tumor, infection, and severe inflammation
- •severe spinal deformity
- •severe cardiovascular and neurological diseases
- •history of spinal surgery
- •currently seeking active treatments for LBP other than medications
- •resting blood pressure more than 160/90 mmHg 49
- •currently taking blood thinning medications
- •uncontrolled diabetes
- •cannot have blood pressure taken
- •participated in a similar trial in the past
研究组 & 干预措施
Aerobic exercise program
Participants will complete 12 week exercise program.
干预措施: Aerobic exercise program (Behavioral)
结局指标
主要结局
Opioid consumption
时间窗: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Use of opioids (dose, frequency, and duration) will be obtained by interviewing the subjects
Pain sensitivity (Pressure pain threshold)
时间窗: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Sensitivity will be measured using a pressure algometer.
2011 FM survey
时间窗: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Sensitivity will be measured using the 2011 Fibromyalgia (FM) Survey Criteria. The survey includes widespread pain index and symptom severity scale. The total score is 31 and scores more than 13 is considered fibromyalgia positive, suggesting presence of central sensitization.
Oswestry Disability Index
时间窗: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
This questionnaire consists of questions related to daily functions and degrees to which back pain interferes with these functions. Each items is measured on a 6-point scale with a total possible score of 50. Higher numbers indicate greater disability.
次要结局
- Pittsburgh Sleep Quality Index(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Lumbar spine range of motion(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Pain Sensitivity (CPM test)(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Beck Depression Inventory(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Fear Avoidance Belief Questionnaire(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Pain Catastrophizing Scale(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))
- Beck Anxiety Inventory(Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment))