Geriatric Balance and Low Back Pain and Balance Assessment and Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
研究概览
简要总结
This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.
详细描述
This study uses a randomized controlled research design and will enroll up to three hundred patients. Treatment will take place in outpatient facilities. It is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. The results of this study will help to further define effective treatment protocols.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between ages 60-85
- •self reported balance problems
- •With or with out low back pain.
排除标准
- •History of recent fracture or surgery of lumbar spine, pelvis, hip or femur
- •History of recent neoplasm (minor skin cancers are not excluded)
- •Acute infectious disease
- •Chronic low back pain persisting for >8 weeks
- •Severe disabling health problems so that patient is not ambulatory
- •Non-mechanical low back pain
- •Recent unstable peripheral vascular disease and or cardiac disease requiring recent hospitalization < 6 months ago
- •Patients with balance problems related to the following: Meniere's disease, vertigo, or vestibular disorders
- •Recent history of self reported substance abuse
- •Ongoing treatment for balance problems or low back pain by chiropractor, physical therapist, or orthopedic physician or other physician.
- •Current use of medication from the following categories: antipsychotics, anxiolytics, and sedative/hypnotics
结局指标
主要结局
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
时间窗: Baseline, week 6 and week 12.
Participants complete functional performance tests and self-report questionnaires related to balance, pain, and quality of life. Testing is performed at baseline, after 6 weeks of care, and at 12 weeks. Balance tests included the Berg Balance Scale, The Timed Get up and Go (TGUG) test, Performance-oriented mobility assessment (POMA), NeuroCom Balance assessment tests which included the Limits of Stability (LOS) Test and Modified Clinical test for the sensory integration of Balance (Mod CTSIB).
次要结局
- Change in patient pain levels at baseline, 6 weeks and 12 weeks.(Baseline, week 6 and week 12.)
研究者
Dennis Enix, DC, MBA
Associate Professor
Logan College of Chiropractic