Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- Total Costs
研究概览
简要总结
The specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the United States.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic low back pain (lasting more than 3 months) who are between 18 to 84 years old will be eligible for the study. Inclusion criteria will be specified by the following the 2017/2018 International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes associated with chronic low back pain:
- •M54.16 Lumbar radiculopathy
- •G57.01 Lesion of sciatic nerve, right lower limb
- •G57.02 Lesion of sciatic nerve, left lower limb
- •M48.061 Lumbar spinal stenosis, without neurogenic claudication
- •M48.062 Lumbar spinal stenosis, with neurogenic claudication
- •M47.816 Lumbar spondylosis
- •M48.07 Lumbar spinal stenosis, lumbosacral
- •M54.41 Lumbago with sciatica, right side
- •M54.42 Lumbago with sciatica, left side
排除标准
- •Patients with diabetic neuropathy, congenital lumbar and sacral abnormalities, lumbar fracture, multiple myeloma, metastatic bone disease, history of spinal and/or pain lasting less than three months will be excluded from the study.
结局指标
主要结局
Total Costs
时间窗: 4 months
The cost data will be collected from the electronic medical record of each patient enrolled in the study. Because the costs for comparable treatments vary with respect to different socioeconomic and geographic regions in the United States, the mean total-healthcare costs per patient will be calculated based on codes for 2018 Medicare fee schedules for each clinic listed in the Current Procedural Terminology (CPT) for office visits, medications, OMT, and referrals.
次要结局
- Total Morphine-Equivalents(4 months)
研究者
Richard Jermyn, DO
Director of the NeuroMusculoskeletal Institute (NMI) and Professor and Chair of Rehabilitation Medicine
Rowan University