Comparison of Internal Disc Decompression (IDD) vs. a Standardized Non-surgical Treatment Program for Chronic Low Back Pain Secondary to Mild to Moderate Degenerative Disc Disease (DDD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.
研究概览
简要总结
This study is looking at a new machine called the Accu-Spina which administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.
详细描述
This study is a randomized trial where out of every 3 people, 2 will receive IDD therapy and 1 will have standardized physical therapy. Patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. If at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Chronic low back pain for > 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies
- •Over 18 years old
- •Able to provide written informed consent
排除标准
- •Infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system
- •Evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc
- •Uncontrolled mood disorder
- •History of drug or substance abuse
- •Lumbar spine pathology requiring surgical intervention
- •Previous spine surgery of the lumbar spine, except discectomies >12 months
- •Improvement with similar non-surgical treatments in the last 3 months
- •Active litigation, workers compensation
- •Females whom are pregnant
结局指标
主要结局
Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.
次要结局
- Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.
研究者
Kyle Webb
Research Administrator
Emory University