Comparison of the Effects of Foundation and Functional Inspiratory Muscle Training in Addition to Classical Physiotherapy in Non-Specific Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of Sociodemographic Information
研究概览
简要总结
This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.
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 (Outcomes Assessor)
盲法说明
Evaluations will be made by a single evaluator who is unaware of the groups.
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
- 否
入选标准
- •Volunteering to participate in the study,
- •Being between the ages of 18-65,
- •Having low back pain that has been ongoing for at least 3 months (12 weeks),
- •Having a Visual Analog Scale (VAS) of pain intensity of ≥3,
- •Being right-hand dominant.
排除标准
- •Not volunteering to participate in the study,
- •Having a history of cancer,
- •Having a spinal infection,
- •Having a rheumatological condition,
- •Having a spinal fracture,
- •Having red flag signs (sudden and unexpected weight loss, fever, etc.)
- •Having a psychological disorder,
- •Having a previous spinal surgery,
- •Having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression),
- •Not continuing home exercises more than 80%,
- •Having an anatomical and congenital abnormality
研究组 & 干预措施
Classical Physiotherapy Group
干预措施: Classical Physiotherapy Group (Other)
Foundation Inspiratory Muscle Training
干预措施: Classical Physiotherapy Group (Other)
Foundation Inspiratory Muscle Training
干预措施: Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy (Other)
Functional Inspiratory Muscle Training Group
干预措施: Classical Physiotherapy Group (Other)
Functional Inspiratory Muscle Training Group
干预措施: Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy (Other)
结局指标
主要结局
Evaluation of Sociodemographic Information
时间窗: Baseline
Participants' sociodemographic information form will include body weight (kilogram).
Assessment of Pain Intensity
时间窗: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
Pain intensity will be measured with Visual Analog Scale (VAS). VAS asks the patient to mark the intensity of pain he/she has felt during the past week between 0-10 cm (0- I have no pain, 10- I have the most severe pain I can feel). High scores indicate severe pain. VAS is a valid and reliable method for determining the intensity of pain in individuals with NSCLBP.
Evaluation of Disability Level
时间窗: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
The level of disability will be assessed with the Oswetry Disability Index (ODI). The level of disability due to back pain in patients with limitations in their daily lives and functional movements was assessed with the ODI. The ODI, consisting of 10 questions, questions the patients' travel activities, sexual life, sleep, social life, sitting, walking, standing, pain intensity, lifting and personal care activities. Each question is scored between 0-5 (0- Does not interfere at all, 5- Completely interferes). High scores indicate a high level of disability.
Respiratory Muscle Strength Assessment
时间窗: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
Respiratory muscle strength will be measured before and after interventions for peripheral muscle strength. Respiratory muscle strength will be measured with a portable device (Intraoral pressure measuring device) that can measure intraoral pressure electronically. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be recorded with intraoral pressure measurement, which is a non-invasive method .
Diaphragm, Transversus abdominis and Multifidus, Muscle Thickness Evaluation
时间窗: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
Diaphragm thickness and mobility will be evaluated with ultrasonography Clarius C3HD, (Clarius Mobile Health, BC, Canada). Diaphragm thickness measurements will be made using 8-15 mHz linear probe from 8-9th intercostal space. Functional residual capacity (FRC) level will be measured at the end of maximum expiration and total lung capacity (TLC) level will be measured at the end of maximum inspiration. Thickening ratio will be calculated using end-inspiratory diaphragm thickness/end-expiratory diaphragm thickness formula, and thickening fraction will be calculated using end-inspiratory thickness-end-expiratory thickness/end-expiratory thickness formula. Diaphragm mobility will be evaluated using M-mode during rest and deep inspiration with 1-6 mHz convex probe.
次要结局
- Physical Activity Assessment(Baseline)
- Evaluation of Exercise Capacity(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Evaluation of Flexibility(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Lower and Upper Extremity Muscle Strength(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Core Endurance Assessment(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Postural Control Evaluation(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Evaluation of Quality of Life(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Fear of Movement(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Pain Catastrophizing(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Anxiety and Depression(Baseline- 10 weeks- 3 Months- 6 Months- 1 Year)
- Treatment Satisfaction(10 weeks)
- Willingness for Treatment(Baseline)
研究者
Fatih ÖZYURT
Physiotherapist, Research Assistant
Kirsehir Ahi Evran Universitesi