Investigating the Effectiveness of Diaphragmatic Release in Patients With Low Back Pain.
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Karabuk University
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain severity
概览
简要总结
Low back pain is one of the most common musculoskeletal disorders, significantly affecting the quality of life of individuals. In non-specific low back pain, a lack of stabilization in the core region negatively impacts the performance of activities. The diaphragm forms the framework of the core region, and its dysfunction can contribute to both respiratory problems and low back pain. This study will investigate the effects of diaphragm relaxation, added to spinal stabilization exercises, on pain, disability, quality of life, central sensitization, and trunk muscle endurance.
详细描述
Low back pain is one of the most common musculoskeletal problems, limiting daily life activities, leading to loss of productivity, and significantly reducing quality of life. In non-specific low back pain, insufficient stabilization in the trunk region and inadequate activation of deep muscles reduce the effectiveness of functional movements and contribute to chronic pain. The diaphragm, a crucial component of trunk stability, plays a critical role not only in respiratory function but also in maintaining spinal stability through the regulation of intra-abdominal pressure. Dysfunction or insufficient relaxation of the diaphragm can lead to changes in breathing patterns, impaired postural control, and persistent low back pain.
Therefore, a better understanding of the diaphragm's role in low back pain mechanisms and its targeting in therapeutic interventions is becoming increasingly important. This study aims to investigate the effects of diaphragm relaxation techniques, applied in addition to spinal stabilization exercises, on pain intensity, disability level, quality of life, central sensitivity, and trunk muscle endurance.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind (Participant, Investigator)
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
- •Being between 18-65 years of age
- •Having been diagnosed with chronic non-specific lower back pain (pain between the gluteal folds and the 12th ribs lasting at least 12 weeks and without a known pathoanatomical cause)
- •Being willing to participate in the study
排除标准
- •Psychological disorders, mental disorders, cancer, and severe depression
- •History of primary or metastatic spinal malignancy or spinal fracture
- •Neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
- •Having been diagnosed with advanced osteoporosis
- •Having undergone previous surgery or had an acute infection in the lumbar region
结局指标
主要结局
Pain severity
时间窗: Baseline, After intervention (eight week later)
The severity of back pain will be assessed using the Visual Analog Scale (VAS). Patients choose the appropriate score between 0 and 10. Higher scores indicate higher pain levels.
Central sensitization
时间窗: Baseline, After intervention (eight week later)
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Disability levels
时间窗: Baseline, After intervention (eight week later)
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Quality of life level
时间窗: Baseline, After intervention (eight week later)
In the SF-36 quality of life assessment, each sub-parameter is scored on a scale of 0. 0 is the lowest score and 100 is the highest.
Trunk muscle endurance
时间窗: Baseline, After intervention (eight week later)
The endurance of the trunk flexor and extensor muscles will be evaluated. Increasing the duration of the test indicates an increase in endurance.
次要结局
未报告次要终点
研究者
Musa Güneş
Principal Investigator, PhD
Karabuk University