The Effect of Sleep Hygiene, Breathing and Stabilization Exercises on Pain, Sleep Quality and Anxiety Level in Patients With Chronic Non-Specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pain at 3 weeks and 8 weeks
研究概览
简要总结
The aim of this study is to compare the effect of sleep hygiene, breathing exercises, and stabilization exercises on pain, sleep quality, and anxiety level in patients with non-specific chronic low back pain.
详细描述
Addressing sleep problems in patients with chronic non-specific low back pain (LBP) can reduce chronic pain, the risk of developing depressive illness and improve pain-related quality of life.
Sleep is a concept that has physiological, psychological, and social dimensions. Sleep is one of the essential and indispensable daily life activities that affect individuals' quality of life and well-being. Decreasing pain is expected and likely to improve sleep quality. Still, it is unknown what will happen due to improving sleep quality to resolve the pain of unknown origin.
Education about sleep hygiene with physiotherapy has not been assessed before on individuals with nonspecific LBP. Since this training will require a lifestyle change, individuals should be warned not once but several times in a certain time, and this training should be reinforced. This will be an advantage for the patients receiving physiotherapy, and their therapists will support them in applying this training during the physiotherapy sessions.
In our study, individuals with nonspecific chronic low back pain will be divided into three groups using the blinding method as part of a randomized controlled trial.
The first group, as the conventional physical therapy group, will receive a hot pack and TENS only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals between the ages of 18-65
- •Having low back pain for at least the last 3 months
- •Pain at 4 out of 10 according to VAS (Visual Analogue Scale)
排除标准
- •Radiculopathies
- •Body mass index > 35
- •Neurological, orthopedic, or cardiopulmonary diseases that will contraindicate exercise
- •Treatment for pain in the last 3 months who have received
- •individuals who can't cooperate and those who have problems adapting to exercises
结局指标
主要结局
Change from Baseline in Pain at 3 weeks and 8 weeks
时间窗: Baseline, 3 weeks, 8 weeks
Visual Analogue Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 3 weeks intervention and at the end 8 weeks from baseline.
Change from Baseline in Form of Pain at 3 weeks and 8 weeks
时间窗: Baseline, 3 weeks, 8 weeks
Form of Pain will be assessed with the Mcgill Melzack Pain Questionnaire. The questionnaire consists of four parts. In the first part, the individual marks the place where they feel pain on a representative body picture and indicates with the letters "D" if the pain is deep, "S" if it is on the body surface, and "D-S" if it is both deep and superficial. In the second part, there are 20 statements that examine pain from various aspects. The individual is asked to choose the word group that fits their pain and to marks only one word in the selected group that fits their pain. In the third part, there are questions about the relationship between time and pain. In the fourth part, five word-groups ranging from "mild to unbearable" pain are defined to determine the severity of pain.
Change from Baseline in Anxiety at 3 weeks and 8 weeks
时间窗: Baseline, 3 weeks, 8 weeks
Anxiety will be assessed with the Spielberger State-Trait Anxiety Inventory. It consists of two separate scales, each with 20 questions, assessing the levels of state anxiety and trait anxiety. The score that can be obtained from both scales is a minimum of 20 and a maximum of 80. If the score from the scale is high, the person's anxiety is high.
Change from Baseline in Sleep Quality at 3 weeks and 8 weeks
时间窗: Baseline, 3 weeks, 8 weeks
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a 19-item self-report questionnaire that measures subjective sleep quality over the previous month. The individual 19 items in the PSQI are aggregated into seven components that assess various aspects of sleep, and the sum of these seven components yields a score that distinguishes between "good" and "bad" sleepers.
Change from Baseline in Fatigue at 3 weeks and 8 weeks
时间窗: Baseline, 3 weeks, 8 weeks
Fatigue will be assessed with the Fatigue Severity Scale. This scale consists of 9 items in total. Individuals give points from 1 to 7 for each item. If the average score is greater than 6.1, it is concluded as chronic fatigue.
次要结局
- Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain(Baseline)
研究者
Samed Gulyilmaz
Principal Investigator
Hasan Kalyoncu University