Studies on understanding the relationship between chronic neck pain and sleep disturbance: A physiotherapy intervention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1 Objective (PSG) sleep parameters.
研究概览
简要总结
1. Thisstudy shall provide an understanding of subjective sleep quality andfatigue in chronic neck pain patients (study 1).
2. ThisStudy will examine the prevalence of sleep disturbance and its correlation withpain ,fatigue and other measures in CNP patients(Study1_
3. This study will illustrate objective qualityof sleep, UT fatigue and nocturnal UT muscle activity in CNP patients Study(II).
4. The main clinical contribution of this studyis to help patients with chronic neck pain to reduce their pain and improvetheir sleep quality and QOL Study (II).
5. The present study will also elucidate the effectof various physiotherapy interventions to ameliorate pain in CNP patients withsleep disturbances Study (II).
6. If came out with positive findings, thepresent study protocol may be used for improving sleep, fatigue aswell as reducing the pain and improve the quality of life in CNPpatients Study(II).
7. The study will also further strengthen theevidence on the role of non-invasive and non-pharmacological interventions toimprove sleep and reduce the pain in CNP patients Study (II).
8. As a whole, this study will be one of thevery few adequately sampled randomized control trials investigating the effectof physiotherapy interventions, which could targets the underlying mechanism ofsleep disturbance, fatigue and pain in CNP patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1 CNP patients who were poor sleepers (score > 5 on Pittsburgh Sleep Quality Index (PSQI).
- •2 Aged between 21 to 50 years.
- •3 Suffering from non-radicular CNP for at least 12 weeks < seven years (as it is documented that patients with long term chronic pain (> 7 years) have the capability of developing pain coping skills 4 Had a working knowledge of English.
排除标准
- •Patients were excluded if they were: 1 taking any prescribed medication that could impact sleep.
- •2 suffered from any other musculoskeletal pain condition or having any life-threatening condition 3 Reported any symptoms of Obstructive Sleep Apnea/Sleep disordered breathing.
- •4 Severe fatigue as assessed by Multidimensional Fatigue Inventory 5 Severe daytime sleepiness as assessed by the Epworth Sleepiness Scale( >15) 6 Frequent and severe headache and dizziness.
- •7 Severe depression and anxiety as assessed by Hospital Anxiety and Depression Scale (>10).
- •8 periodic Limb Movement Disorder rating of >5 .
- •9 Reported symptoms of Vertebrobasilar Insufficiency during physical examination.
- •10 High alcohol or caffeine alcohol intake.11 shift worker.
- •12 Having travelled across more than two time zones in the last month or having journeyed across more than one time zone in the last week.
结局指标
主要结局
1 Objective (PSG) sleep parameters.
时间窗: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
2 Myoelectric Manifestations/fatigue parameters of upper trapezius (Mean, median power frequency and RMS).
时间窗: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
4. Pain Intensity
时间窗: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
3. Nocturnal Activity of upper trapezius during Wake, NREM and REM sleep.
时间窗: Pre intervention (day 0) and post intervention (after 7 weeks (30 sessions)
次要结局
- disability(Craniocervical Flexion Test)