Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change from baseline Muscular fitness at 2 months: lower body strength
研究概览
简要总结
Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP. The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al.
- •Intend to participate in the intervention and perform all the tests included in the study.
- •Able to read and understand informed consent, as well as the objective of the study.
- •Able to walk and move without outside help.
- •Able to communicate without problems
- •Be between 18 and 65 years old.
排除标准
- •Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered).
- •Having lumbar surgery as source of pain.
- •Having acute or terminal illness.
- •Having medical prescription that prevents the performance of the tests.
- •Having injury or circumstance that makes it impossible to perform the tests correctly.
- •Having other physical or mental illness that prevents participating in the intervention.
研究组 & 干预措施
Exercise
The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
干预措施: Exercise (Behavioral)
Exercise + mindfulness
The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
干预措施: Exercise + mindfulness (Behavioral)
Control
The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks
干预措施: Control group (Other)
结局指标
主要结局
Change from baseline Muscular fitness at 2 months: lower body strength
时间窗: Change from baseline at 2 months (Postest minus Retest)
It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
Change from baseline Muscular fitness at 5 months: lower body strength
时间窗: Change from baseline at 5 months (Retest minus Pretest)
It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance
时间窗: Change from baseline at 2 months (Postest minus Retest)
It will be measured with the Biering-Sørensen test and the plank test.
Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance
时间窗: Change from baseline at 5 months (Retest minus Pretest)
It will be measured with the Biering-Sørensen test and the plank test.
Change from baseline Muscular fitness at 2 months: upper body strength
时间窗: Change from baseline at 2 months (Postest minus Retest)
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
Change from baseline Muscular fitness at 5 months: upper body strength
时间窗: Change from baseline at 5 months (Retest minus Pretest)
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
次要结局
未报告次要终点
研究者
Víctor Segura Jiménez
Principal Investigator
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental