The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual Analog scale
研究概览
简要总结
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.
详细描述
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study.
The study will be designed as Crossover. The study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. Following both orthosis insertion methods, pain severity will be measured with Visual Analogue Scale (VAS) and comfort level was measured with Orthosis Comfort Score. They will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. Y Balance Test (YBT) and Functional Reach Test (FRT) will be used for dynamic balance. Plantar pressure and static balance will be analyzed with pedobarography device. Static Pressure and stabilometric data will be found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-65,
- •One or more recurrent low back pain during the last 12 months,-At least 6 points on the Oswestry Disability Index,
- •Negative straight leg raising test result,
- •Not having any lower extremity injuries in the last 6 months,
- •No history of recent trauma or infection
排除标准
- •Neurological symptoms due to nerve root compression
- •One-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia,
- •Disease that causes neurological sequelae (stroke, traumatic brain injury, Parkinson's, Those who have had it (such as multiple sclerosis),
- •Presence of malignancy,
研究组 & 干预措施
First Intervention
The application will be done sequentially: without orthosis, with adaptation and with orthosis.
干预措施: First Intervention (Other)
Second Intervention
The application will be done sequentially: with adaptation, with orthosis and without orthosis
干预措施: Second Intervention (Other)
Third Intervention
The application will be done sequentially: with orthosis, without orthosis, and with adaptation
干预措施: Third Intervention (Other)
结局指标
主要结局
Visual Analog scale
时间窗: 5 minutes
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson\[1\]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised
Pedobarographic evaluation
时间窗: 5 minutes
Foot plantar pressure distribution (static pedobarographic) analyzes and postural stability parameters will be performed through a computer-aided data collection and display system. Sensor Medica (Rome, Italy) Pedobarography Device, which has a pressure-sensitive platform connected to the computer and a software system that records and analyzes the data. Measurements will be made for individuals with low back pain.
Y balance test
时间窗: 15 minutes
Y Balance Test, strength, flexibility, filter control and proprioception.Taking a one-legged stand is a reliable test for exercising dynamic balance. Three-way reach carries out operations of individuals of individuals. They were asked to lie down to the last magnification without disrupting the alignment with the side to be tested and to return to the center after each stretch. After trial access, access was requested in three directions. Measurements are fired with 10-second breaks between trials and 20-second breaks between directions. The reach made after 3 reach attempts for each direction was measured and taken into the recording area, and the test was used in the overall performance analysis.
Orthosis comfort score
时间窗: 10 minutes
An orthosis comfort score, which is valid and reliable and developed from the socket comfort score, will be used to evaluate comfort. The score measures the comfort felt by the patient between values of 0 and 10. "How would you rate the comfort of the orthosis?" They are expected to answer the question as 0 is the most uncomfortable orthosis and 10 is the most comfortable orthosis.
Functional Reach Test (FRT)
时间窗: 5 minutes
Functional Reach Test (FRT) is a assessment tool for ascertaining dynamic balance in in simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with risk of falling.
次要结局
未报告次要终点
研究者
merve yilmaz menek
Principal Investigator
Istanbul Medipol University Hospital