Effectiveness of Functional Rehabilitation With HUBER Platform Compared to a Standard Program, on the Flexion/Extension Ratio of the Spine, in Patients With Non-specific Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in the flexor to extensor ratio measured by Cybex at 60°/s.
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of centre-based program of 6 weeks with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s, pain and trunk flexibility in individuals with chronic low back pain (CLBP). A total of 70 individuals with Non-specific Chronic Low Back Pain will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week.
详细描述
The prevalence of chronic low back pain (CLBP) is increasing with age and the prevalence of sedentary lifestyle. According to guidelines, non-pharmacological approaches such as exercise and physical therapy have been proposed in first line treatments along with psychological follow-up and pain medication if needed. The physiotherapy, used in a comprehensive CLBP rehabilitation program, aims to decrease chronic pain and promotes proprioceptive and postural work, as well as spinal mobility, flexibility and muscle strengthening of the spinal area. Isokinetic concentric strength assessment at 60 and 120˚/s is one of the most commonly used criteria to examine the trunk flexors and extensors muscles strength. The objective of this study is therefore to evaluate the effectiveness of an intensive care program with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s measured by Cybex, pain and trunk flexibility in individuals with non-specific CLBP. A total of 70 individuals with CLBP will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week. All the sessions will be supervised by a physiotherapist and will include 1h of physiotherapy, 30min of balneotherapy and 30min of exercise on cycloergometer for the standard rehabilitation group or 30min of exercise on the HUBER platform for the HUBER group. All patients included will benefit from medical monitoring, evaluations and the rehabilitation program set up at the Clinique de Tréboul, Douarnenez, France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people aged between 20 - 55 years old
- •with non-specific chronic low back pain (over 3 months)
- •with clinical and radiological assessment.
排除标准
- •chronic low back pain of specific etiology (trauma, tumor, inflammatory or infectious disease, and radicular syndrome)
- •spine with major anatomical deformations
- •any contraindication for the rehabilitation program
- •surgery less than 3 months and/or receiving treatment with corticosteroids.
结局指标
主要结局
Change in the flexor to extensor ratio measured by Cybex at 60°/s.
时间窗: Baseline and post-intervention at 6 weeks
change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s
次要结局
- Change in the flexor to extensor ratio measured by Cybex at 120°/s.(Baseline and post-intervention at 6 weeks)
- Change in the peak torque of the extensor muscles of the spine measured by Cybex at 60 and 120°/s.(Baseline and post-intervention at 6 weeks)
- Change in the peak torque of the flexor muscles of the spine measured by Cybex at 60 and 120°/s.(Baseline and post-intervention at 6 weeks)
- Change in the hamstring extensibility (Right/Left) (in degrees)(Baseline and post-intervention at 6 weeks)
- Change in Extensibility of the Psoas (Right/Left) (in degrees)(Baseline and post-intervention at 6 weeks)
- Change in Extensibility of the Quadriceps (Right/Left) (in cm)(Baseline and post-intervention at 6 weeks)
- Change in the double-lumbar inclinometry in flexion (in degrees)(Baseline and post-intervention at 6 weeks)
- Change in the double-lumbar inclinometry in extension (in degrees)(Baseline and post-intervention at 6 weeks)
- Change in the double-lumbar inclinometry in inclination (Right/Left) (in degrees)(Baseline and post-intervention at 6 weeks)
- Change in the muscular endurance of the trunk and of the lower limbs (in secondes)(Baseline and post-intervention at 6 weeks)
- Change in the Score of Pain (Scale from 0 to 10)(Baseline and post-intervention at 6 weeks)
- Change in Fear and Avoidance Belief Questionnaire (FABQ) score(Baseline and post-intervention at 6 weeks)
- Change in Oswestry Disability Index questionnaire score(Baseline and post-intervention at 6 weeks)
研究者
Thibaut Guiraud
Thibaut Guiraud, PhD
Orpea Group