A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Tolerability of Electrical Stimulation (NMES)
研究概览
简要总结
The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Between 18 years of age and
- •Body Mass Index (BMI) of less than
- •Low Back Pain duration of 3 months or greater (chronic).
- •Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
- •Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
- •Understands English
排除标准
- •Positive nerve root tension signs
- •Progressive neurological deficit
- •Positive Babinski sign.
- •Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
- •History of spinal surgery
- •History of inflammatory joint disease
- •Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
- •Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
- •History of metastatic cancer in previous 5 years or present treatment for cancer
- •Women who indicate that they are pregnant or plan to become pregnant
结局指标
主要结局
Tolerability of Electrical Stimulation (NMES)
时间窗: Participants were followed from baseline to 6 weeks
NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks. To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low. Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up.
Modified Oswestry Disability Questionnaire (MODQ)
时间窗: Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).
The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.
次要结局
- Fear-avoidance Behavior Questionnaire(Baseline to 6 weeks (post-treatment))
- Patient Satisfaction Survey(only post-treatment at 6 weeks)
- Numeric Pain Rating Scale (NPRS)(Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up))
- Paraspinal Muscle Strength(Baseline - 6 weeks (post-treatment))