Investigation of the Effect of Low Back Pain Level on Symptoms in Individuals With Chronic Consipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Bristol Stool Scale
研究概览
简要总结
Consipation is the most common digestive complaint in the general population
详细描述
Chronic constipation and low back pain are two common and often co-existing health conditions that affect millions of people worldwide. On the surface, these conditions appear to be unrelated and are associated with different anatomical sites (gastrointestinal tract and musculoskeletal system). However, a growing body of research is beginning to shed light on the complex interplay between chronic constipation and low back pain, highlighting potential links between these seemingly disparate health conditions. Common etiologic factors such as neuromuscular function, chronic inflammation and lifestyle-related variables are known to exist
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •18-65 ages
- •Rome III diagnostic criteria
排除标准
- •Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as
- •Multiple sclerosis, stroke, Parkinson's disease or spinal injury,
- •Impaired awareness (mini-mental score < 15),
- •Legal blindness, pregnancy,
- •Rectal prolapse
- •Anal fissure and altered constipation and diarrhea pattern.
结局指标
主要结局
Bristol Stool Scale
时间窗: one day
Lewis and Heaton classified the type of stool in 7 different groups in the scale. In the Bristol Stool Scale, the transit time of stool through the intestine is evaluated over seven different stool types. According to BGS, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool (diarrhea)".
Pelvic Pain Impact Questionnaire
时间窗: one day
The questionnaire for clinical assessment of the impact of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of scores to be obtained from the questionnaire varies between 1- 32. As the score value to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person increases.
Constipation Severity Scale
时间窗: one day
Constipation Severity Scale (CSS) is a scale for determining the frequency, intensity and difficulty/difficulty during defecation. The scale includes 16 questions. The score that can be obtained from the DT sub-dimension is between 0-28, the score that can be obtained from the CBT sub-dimension is between 0-29, and the score that can be obtained from the Pain sub-dimension is between 0-16. The minimum total score that can be obtained from the KCS is 0 and the maximum score is 73. A high score on the scale indicates that the symptoms are serious. The highest score that can be obtained from the five-point Likert-type scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as the scores obtained from the scale increase
Disability level
时间窗: one day
The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain (12). This index consists of 10 items, 8 related to activities of daily living and 2 related to pain. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to more disability). Increasing scores on the Oswestry Disability Index indicate a higher level of disability.
Autonomic nervous system device (Polar H10)
时间窗: one day
The Polar H10 device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can connect to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that contacts the chest to capture heart rate in real time. The study will evaluate the autonomic nervous system with the Polar H10 device. The data will be recorded by connecting the device to a smart phone via bluetooth and the software supported by the device will be used to analyze the data. The participant will be in a sitting position and a measurement will be made for 1 minute. In order for the device to make an accurate measurement, the electrode surface must be wetted before each measurement. The subject should not talk or move during the measurement.
次要结局
未报告次要终点
研究者
hazal genc
Principal Investigator
Istanbul Medipol University Hospital