Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for pain
研究概览
简要总结
Chronic low back pain is one of the main causes of pain, dysfunction and disability worldwide. In Spain, 93% of the population has had back pain in the last year, and it is estimated that 50% of sick leave is due to this cause. This entails a great socioeconomic burden, since it is the main cause of absenteeism from work and the excessive use of therapeutic services.
Musculoskeletal disorders are related and associated with psychologically stressful jobs, that is, with psychosocial factors at work and related work stressors, such as time pressure, low job control, poor social or supervisor support, effort-reward imbalance or work-life conflict. Clinical management of both situations encompasses a variety of approaches, including medication and early physical exercise, which have shown promise in reducing pain and improving function.
A novel approach to address these problems is the use of Xiaxi, a patented postural hammock with multiple angles of inclination that promotes relaxation and elongation of the posterior chain, thereby improving overall well-being. Combining the use of Xiaxi with a comprehensive program of strengthening, stretching and relaxation exercises could offer benefits in the prevention and reduction of back pain.
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
- •Age > 18 years.
- •Presence of back pain.
排除标准
- •Have undergone surgery of the spine, ischiosural muscles, psoas-iliac, pectoral and rotator cuff.
- •to have any structured spinal spine alteration diagnosed by health personnel.
- •have had a rupture of the ischiosural, psoas-iliac, pectoral and rotator cuff muscles in the last year or during the intervention.
- •have any type of injury that prevents you from performing the initial assessment in the first week of the procedure.
- •to have practiced vigorous physical exercise on the day of the investigation or 24 hours before the initial or final assessment.
- •having eaten large meals on the days of the investigation
- •less than two hours had elapsed since any prolonged recumbent rest at the start of the assessment.
研究组 & 干预措施
Control
The control group will lie on a mat on the floor for 10 minutes, 5 days of intervention.
干预措施: Yoga mat (Behavioral)
Xiaxi
The experimental group will lie in the Xiaxi postural hammock for 10 minutes for 5 days.
干预措施: Xiaxi postural hammock (Device)
结局指标
主要结局
Visual Analog Scale (VAS) for pain
时间窗: 1 minute
The VAS will be used to assess the level of pain intensity. The VAS scale allows measuring the intensity of pain described by the patient with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at the ends of which are the extreme expressions of a symptom. On the left side is located the absence or lower intensity and on the right side the higher intensity. The patient is asked to mark on the line the point indicating the intensity and it is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. It is a common, simple, well constructed, validated and reliable method.
次要结局
- International Physical Activity Questionnaire (IPAQ) for Physical Activity(5 minutes)
- General health status, the "SF-36", for quality of life(5 minutes)
- Oswestry Low Back Pain Disability Scale, for disability(5 minutes)
- Pressure pain threshold (PPT), for pain(5 minutes)
- Satisfaction With Life Scale (SWLS) questionnaire, for quality of life(5 minutes)
- Perceived Stress Scale (PSS), for stress(5 minutes)
- The Hospital Anxiety and Depression Scale (HADS), for Anxiety and Depression(5 minutes)
- Modified-Modified Schober Test, for flexibility(2 minutes)
- Angular and a linear test for the assessment of hamstring extensibility for flexibility(2 minutes)
研究者
Josue Fernandez Carnero
Principal Investigator
Universidad Rey Juan Carlos