Comparison Of Spinal Manipulation Applied to the Cervical Spine and Sacroiliac Joints With Pedobarographic Analysis and It's Immediate Effect on the Autonomic Nervous System in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Evaluation of Autonomic Nervous System
研究概览
简要总结
The aim of this study is to investigate the immediate effects of high-velocity low-amplitude (HVLA) chiropractic manipulation on the autonomic nervous system and baropodometric parameters. The effects of different manipulation techniques on pedobarographic analysis and the autonomic nervous system were examined.
详细描述
Ninety-six individuals who met the inclusion criteria participated in the study. The participants were divided into three groups: the sacroiliac joint manipulation group (n=32), the cervical manipulation group (n=32), and the control group (n=30). No treatment was administered to the control group, while sacroiliac joint manipulation and cervical manipulation were applied to the sacroiliac joint manipulation group and the cervical manipulation group, respectively. Autonomic nervous system activity was assessed using the Polar H-10 device, pedobarographic analysis was performed using the METISENS pedobarographic evaluation device, and blood pressure and pulse were measured manually from the left arm using a sphygmomanometer. A 30-minute waiting period was used during the evaluation of the control group. A significance level of p<0.05 was considered
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate voluntarily.
- •Signed informed consent form.
- •Age between 18 and 35 years.
- •No contraindications for chiropractic practices.
排除标准
- •History of orthopedic disabilities related to the lower extremity.
- •Ankylosing spondylitis, rheumatoid arthritis.
- •History of foot sprain/strain within the past six months.
- •Presence of pathologies in the lumbar and sacroiliac regions (herniated discs, spondylosis, spondylolisthesis).
- •History of cardiovascular and respiratory diseases.
- •Psychiatric disorders such as psychosis and depression.
- •Radicular root compressions causing progressive neurological deficits.
- •Bleeding/coagulation disorders and receiving anticoagulant treatment.
- •Acute fractures and orthopedic trauma.
- •Spinal cord tumors and meningeal tumors.
- •Intraosseous infections and acute inflammation, such as osteomyelitis.
- •Cauda equina syndrome.
- •Intracanicular hematomas.
- •Spinal cord hematomas in the spine.
- •Basilar invagination of the upper cervical region.
- •Aneurysmal bone cysts, osteoid osteomas, osteolastomas, giant cell bone tumors.
- •Post-surgical fixation prostheses.
- •Neoplastic diseases in muscles or other tissues.
- •Lhermitte's sign.
- •Syringomyelia.
- •Vertebral dislocations or hypermobile joints.
- •Advanced osteoporosis.
- •Vertebrobasilar insufficiency.
- •Criteria for Withdrawal from the Study:
- •Pregnancy or suspicion of pregnancy.
- •The volunteer's desire to discontinue participation in the study.
结局指标
主要结局
Evaluation of Autonomic Nervous System
时间窗: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
The assessment of the autonomic nervous system was conducted using the Polar H10 device, which is a high-accuracy, gold-standard HRV sensor that comes with a chest-worn strap. The device can connect to multiple components via Bluetooth and ANT+. This device facilitates the measurement of heart rate variability (HRV), R-R intervals, RMSSD (an instantaneous assessment of the parasympathetic system), LF Power (activation of the sympathetic nervous system), HF Power (activation of the parasympathetic nervous system), HF band, and LF/HF ratio (sympathetic-vagal balance). For data analysis, the Elite HRV software supported by the device is utilized. Measurements are conducted while the participant is seated and last approximately one minute. To ensure accurate measurements, it is necessary to moisten the electrode surface before each measurement. During the assessment, the participant should not speak or move
Evaluation of Blood Pressure
时间窗: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Blood pressure of the participants were evaluated with a manual sphygmomanometer on the left arm.
Analysis of Pedobarographic Data
时间窗: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
The analysis of pedobarographic data was conducted using METISENS pedobarographic assessment devices. During the measurements of pressure analysis in individuals participating in our study, static conditions were maintained, and the load distribution on both the right and left feet, as well as the loads on the anterior and posterior aspects of the foot (%), were reported. Pressure analyses were determined using the Metisens Baropodometric Analysis software, which is the proprietary software that operates in conjunction with the Metisens Pedobarographic Assessment Device (It is not possible to separate these measurements as the device takes all measurements and provides a total analysis.)
Evaluation of Pulse
时间窗: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
The pulse of the participants were evaluated with a manual sphygmomanometer on the left arm.
次要结局
未报告次要终点
研究者
SEFA HAKTAN HATIK
Asst. Professor
Sinop University