Orthotic Use for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.
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
- None
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
- •Males and females must be at least 18 years old.
- •Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
- •Symptoms must have been present for at least three months.
排除标准
- •Use of custom-made shoe orthotics in the past year
- •Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
- •Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
- •Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
- •Current or future litigation for low back pain.
- •Chronic pain other then low back pain such as fibromyalgia
- •Low back surgery in last six months.
- •Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
- •Peripheral neuropathy due to disorders such as diabetes.
- •Low back or leg pain that is not reproducible.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Randomization, Week 6, and Week 12
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Visual Analog Scale (VAS)
时间窗: Randomization, Week 6, and Week 12
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
次要结局
未报告次要终点
研究者
Jerrilyn Cambron, DC, PhD
Research and Professor in Dept of Research
National University of Health Sciences