Association between Heart Rate Variability and Sleep among subjects with Chronic Neck Pain and Healthy Controls - A Case-control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- sleep quality measured by polysomnography
研究概览
简要总结
Introduction: Theliterature provides evidence for an association between disturbed sleep and chronic neck pain. Psychological factors (such as depression and anxiety) act as a mediating factor between sleep and pain. Autonomic dysregulation is another important consequence of chronic pain. their is an association between sleep quality and HRV, but only a limited number of studies have explored it.
objective of the study; to identify whether any direct association exists between heart rate variability and sleep quality in subjects with chronic neck pain and healthy controls (HCs) and to compare the differences in heart rate variability and sleep quality in subjects with CNP and HCs.
Methodology; The study will employ case control design (n=38), recruiting subjects in 2 groups – subjects with CNP (n=19) and age- and sex- matched HCs (n=19), based on inclusion and exclusion criteria. Data collection will include HRV, Polysomnography, PPT measurement and self-reported measures (NPRS, NDI, PSQI, WHOQOL-BREF, PIRS). Statistical analysis will be done using correlational analysis and group comparisons.
Conclusion and clinical implication; Result from this study may provide evidence of association between HRV and sleep in subjects with CNP, help in understanding the underlying mechanism, highlighting the importance of addressing sleep disturbance in pain management strategies. Thus, contributing to development of interventions to improve sleep for better treatment outcomes and quality of life
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
- •FOR CASES Chronic non-radicular neck pain lasting more than 6 months Age between 18 and 45 years, regardless of their sex NPRS score greater than 2 and less than 7, i.e., mild and moderate pain Willing to participate in the study Working knowledge of English (had to complete the questionnaires in English).
- •FOR CONTROLS Aged between 18 and 45, regardless of sex Subjects who are healthy and free from physical illness (not having any musculoskeletal pain disorder and not taking any medications currently) Willing to participate in the study Working knowledge of English (have to fill the questionnaires in English).
排除标准
- •H/O any cardiac, spinal, upper limb and lower limb surgery Had CNP ≥ 7 years, which lead to development of coping with pain skills Women who are pregnant and those who are diagnosed with any gynaecological conditions (polycystic ovarian syndrome, dysmenorrhoea, regular contraceptive pills intake, menopause) Cognitive impairment that would limit their participation Subjects taking heavy caffeine (> 350 mg/day), alcohol (>5 standard drinks per week) or other recreational drugs and intense regular physical exercise Subjects who are involved in major life stress situation, such as during the examination period Subjects who are already diagnosed with any sleep disorders Subjects having any lifestyle disorders (hypertension, diabetes, hypothyroidism, 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 using anti-inflammatory, antidepressant drugs such as benzodiazepine, B-blockers, or any other psychotic drugs which can affect pain, autonomic function, and sleep.
- •Any associated cardiovascular disease (valvular heart disease, coronary artery disease, recent myocardial infarction, etc.).
结局指标
主要结局
sleep quality measured by polysomnography
时间窗: Baseline
cardiac autonomic function measured by Heart rate variability
时间窗: Baseline
pain intensity measured by NPRS
时间窗: Baseline
disability assessed by neck disability index
时间窗: Baseline
次要结局
- Quality of life assessed by WHOQOL-BREF(Subjective sleep quality assessed by Pittsburgh sleep quality index (PSQI))
研究者
Dr Zubia Veqar
Jamia Millia Islamia University