A Polysomnographic Investigation of Sleep Disturbance 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
- 32
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The patients will be recruited from the community and the Centre for Physiotherapy and Rehabilitation Sciences(CPRS) clinic, Jamia Millia Islamia on the basis of the inclusion and exclusion criteria. Patients would be required to sign the consent form explaining the rights as research subjects. All the identifying information on the consent form and the demographic data shall be confidential. The assessment of the patient will include demographic data, anthropometric characteristrics and screening for chronic low back pain, following which the patients will be assessed for objective sleep using Polysomnography device, pain using NPRS, quality of life using WHOQOL-BREFF, subjective sleep quality using St. Mary’s Hospital Sleep Questionnaire and functional disability by 10-item Oswestry Disability Index.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Chronic Low back Pain more than twelve weeks and less than seven years NPRS score of 3-7 participant who are healthy and free from physical illness Willingness to participate in the present study Working knowledge of the English language (to fill out the questionnaires and consent form).
排除标准
- •They will have a history of low back pain ≥ 7 years, leading to the development of coping with pain skills more than 50 years of age because of the decrease in slow wave sleep (SWS) that occurs in this age group Cognitive impairment that would limit their participation Participant who will be taking heavy caffeine (more than 350 mg/day), alcohol (more than 5 standard drinks per week), or other recreational drugs Participant who will be performing intense regular physical exercise Participant dealing with major life stress situations, such as examination preparation, job seeking, etc.
- •Participant already diagnosed with any sleep disorders Participant having any lifestyle disorders (hypertension, diabetes, hypothyroidism, etc) Subjects having chronic secondary musculoskeletal pain (pain due to inflammatory conditions, infections, auto-immune disease, nervous system disease, local structural musculoskeletal changes) Participant consuming any anti-inflammatory, antidepressant drugs such as benzodiazepine, B-blockers, or any other psychotic drugs that can affect pain, autonomic function, and sleep.
- •Psychological disorders, cognitive impairment for atleast six weeks Any associated cardiovascular disease (valvular heart disease, coronary artery disease, recent myocardial infarction, etc.).
结局指标
主要结局
Pain intensity
时间窗: On day 1
Functional disability
时间窗: On day 1
Objective sleep
时间窗: On day 1
次要结局
- Subjective sleep quality(Quality of life)
研究者
Dr Zubia Veqar
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia