Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sleep Measures
研究概览
简要总结
Our goal is to observational study is to determine feasibility of partial sleep restriction in individuals with CLBP+I and correlation findings with features of central sensitization.
- Identify feasibility of sleep restriction protocol
- Identify correlation between less sleep and central sensitization Sleep will be monitored for 2 weeks (baseline sleep monitoring period). Then participants will be asked to restrict their sleep to 80% of their normal sleep duration for 5 nights (sleep restriction period). Then sleep will be monitored again for 2 weeks (sleep recovery period).
详细描述
Actigraph and sleep diaries will be used to record sleep time and quality of sleep for 2 weeks baseline period. During this period several measures for pain, sleep, fatigue, cognition, and psychological status will be completed. Quantitative sensory testing will be used to establish pain threshold. Then, the participants will partial sleep restriction (20% sleep reduction/night for 5 nights). Following the completion of restricted sleep period, all outcome measures related to pain, sleep, fatigue, cognition, and psychological status will be assessed (post-sleep restriction assessment). Then participants' sleep will be monitored for 2-weeks (sleep recovery period). During the 5-night of sleep restriction, participants will be asked to complete electronic daily diary related to sleep, pain, fatigue, psychological distress and physical activity. Potential risk related to less sleep will be clearly explained to all potential individuals interested in participating.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-65 years old individuals
- •Additional inclusion criteria for individuals with CLBP+I:
- •With or without insomnia
- •CLBP (LBP for at least 3 months with or without referred or radiating leg pain; pain intensity 1 or greater on 0 - 10 VAS scale
- •likely to participate in all scheduled evaluations and study procedures by self-report
- •agrees to abide by safely protocol e.g. not to drive or operate heavy machinery and perform heavy labor work, during the sleep-restriction period
排除标准
- •spine compression, tumor, infection, history of spine surgery
- •neurological conditions such as stroke, Parkinson's disease, Alzheimer's disease or other cognitive impairments.
- •pregnancy
- •known untreated sleep disorder (such as current sleep apnea or current restless leg syndrome) screened by the following scales to ensure insomnia symptoms are due to insomnia and not another common sleep disorders:
- •Those with increased risk of sleep apnea
- •Increased risk of restless leg syndrome on RLS-Diagnosis Index
- •Increased risk of circadian rhythm sleep-wake disorder
- •Increased risk of parasomnia
- •Moderate level of depression identified by Patient Health Questionnaire (PHQ-9)
- •Moderate level of anxiety identify by Generalized Anxiety Disorder (GAD-7)
- •history of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- •severe mental illness such as schizophrenia or bipolar disorder
- •developmental history of learning disability or attention-deficit/hyperactivity disorder
- •is currently receiving CBT-I, physical therapy or chiropractic treatment
- •history of spinal surgery
- •current use of blood thinning medications
- •resting blood pressure greater than 160/90 mmHg40,49,50
- •performs overnight shift work
- •Additional exclusion criteria for HC individuals:
- •pain rating 0 out of 0 - 10 Numeric Rating Pain Scale in any parts of the body
结局指标
主要结局
Sleep Measures
时间窗: Through study completion, up to 5 weeks
Pittsburgh Sleep Quality
Pain Measures
时间窗: Through study completion, up to 5 weeks
SF-McGill (MPQ),
次要结局
- Sleep Measures(Through study completion, up to 5 weeks)
- Psychological Measures(Through study completion, up to 5 weeks)
- Daily questionnaire(Through study completion, up to 5 weeks)
- Pain Measures(Through study completion, up to 5 weeks)
研究者
Neena Sharma, PT, PhD, CMPT
Associate Professor
University of Kansas Medical Center