Association Between Cardiac Autonomic Function, Stress And Sleep in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cardiac Autonomic Nervous system: Heart rate variability
研究概览
简要总结
This study will be carried out at the Human performance laboratory and out-patient department, Centre for Physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia University, New Delhi, India. The participants in both groups will be recruited based on inclusion and exclusion criteria. Participants will fill questionnaires (PSQI, Cohen’s perceived stress questionnaaire and PROMIS-8 B scale, ) followed by objective assessment of HRV,orthostatic stress test, Hand Grip test,Cold Pressor test. The HRV will be recorded through a 3-lead ECG in the supine position. The electrodes will be placed on bony prominences, and depending on the color of the electrode, white is placed on the right ulnar styloid process, green on the right medial malleolus, and black on the left medial malleolus. It has time domains such as mean R-R interval, SDNN, rMMSD and PNN50 and frequency domains – high frequency (HF), low frequency (LF), and LF/HF.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic Low back pain patients Participants having chronic low back pain for more than 3 months.
- •Age between 18 to 45 years Both the genders.
- •NPRS score more than 2 and less than 7 i.e. mild and moderate pain BMI between 18 to 29.9 kg/m2 Willing to participate in the study Working knowledge of English Inclusion criteria for healthy subjects Participants who are healthy and free from physical illness (not having musculoskeletal disorder and not taking any medications currently).
- •Age between 18 to 45 years.
- •Both the gender BMI between 18 to 29.9 kg/m2 Willing to participate in the study Working knowledge of English.
排除标准
- •Conditions or medications that will affect the HRV measurements, such as Hypertension, Diabetes.
- •Currently using anti-inflammatory, pain-reducing medication on a daily basis, steroids, beta-blockers or antidepressants such as benzodiazepine or any other psychotic drugs which can affect pain, autonomic function and sleep.
- •Subject with Radiculopathy Subjects who are already diagnosed with any sleeping disorder Any associated cardiovascular disease (valvular heart disease, coronary artery disease, recent myocardial infarction etc Subjects who are considered having chronic secondary musculoskeletal pain (pain due to inflammatory conditions, infections, auto-immune disease, nervous system disease, local structural musculoskeletal changes) Subjects having any lifestyle disorders (hypertension, diabetes, hypothyroidism, etc) Subjects who are involved in major life stress situation, such as during the examination period Subjects taking heavy caffeine (more than 350 mg/day), alcohol (more than 5 standard drinks per week) or other recreational drugs and intense regular physical exercise Women who are pregnant History of any cardiac and spinal, upper limb and lower limb surgery.
结局指标
主要结局
Cardiac Autonomic Nervous system: Heart rate variability
时间窗: At day 1
A) Orthostatic stress test
时间窗: At day 1
B) Deep breathing test
时间窗: At day 1
C) Cold pressor test
时间窗: At day 1
D) Hand grip test (HGT)
时间窗: At day 1
次要结局
- Stress assessed subjectively(Subjective sleep quality)
研究者
Dr Zubia Veqar
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia