跳至主要内容
临床试验/NCT01259167
NCT01259167Unknown不适用

JOBA & Chronic LOw BAck Pain

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1

研究概览

简要总结

The purpose of this study was to assess whether a training program based on Joba® Core Trainer is effective in reducing pain and improving physical function and quality of life of subjects suffering from Chronic Low Back Pain.

详细描述

Background and rational

  1. Definition Low back pain is a clinical condition characterized by pain felt between the bottom edge of the costal arch and the inferior gluteus folds, sometimes radiating to the back side of the thigh.

It may be responsible for functional limitation and inability to perform normal activities of daily living. Low back pain is defined as acute if symptoms have a duration less than 4 weeks, sub-acute if the duration is between 4 weeks and 3 months, and chronic if it lasts beyond 3 months. It is considered recurrent when episodes shorter than 4 weeks alternate with periods of relief from pain. 2. Epidemiology Low Back Pain is the most common musculo-skeletal disorder, and, along with common cold, is the most frequent disease among humans.

Up to 60-80% of population is expected to suffer from Low Back Pain at some time in life. Annual prevalence of Low Back Pain ranges from 30 to 50% amongst people in the working period of their life; out of these individuals, a percentage between 15 and 20% do necessitate medical assistance. Low Back Pain is the fifth-ranking cause of medical referral and the second symptomatic condition. A proportion ranging from 25 and 50% of patients with acute Low Back Pain will suffer from new pain episodes in the following year and 6-10% will progress toward a chronic form.Chronic Low Back Pain is responsible for about 75% of all medical expenses made for the treatment of all types of Low Back Pain. Direct annual costs (medications, medical visits, physiotherapy, hospitalizations) of Chronic Low Back Pain have been estimated to be approximately € 3.100 for patients (year 2002); indirect costs, mainly due to absence from work, represent about 85% of total costs and match up about € 17.600 for patient for year. In conclusion, Chronic Low Back Pain is a disease with very high prevalence and incidence, evenly affecting men and women in their 30's and 50's, which is extremely costly for individuals and society, both in terms of diagnostic interventions and treatments, and of reduction of productivity and functional limitation in everyday life. 3. Non-Pharmacologic treatments Non-Pharmacologic treatments of Chronic Low Back Pain include: acupuncture, back school, psychological interventions, functional restoration, interdisciplinary rehabilitation, interferential therapy, low-level laser therapy, lumbar support, massage, short wave diathermy, spinal manipulations, tractions, superficial heat, transcutaneous electrical nerve stimulations (TENS), ultrasound therapy, yoga and physical exercise.

A recent meta-analysis based on 43 clinical controlled trials involving 3.907 subjects with Chronic Low Back Pain demonstrated that physical exercise is effective in reducing pain and improving functional level. The most recent Guidelines, published in October 20007, underline that, along with cognitive-behavioural therapy, spinal manipulations and interdisciplinary rehabilitation, physical exercise is the only non pharmacologic treatment having a positive effect on Chronic (or subacute) Low Back Pain. 4. Vertebral instability and physical exercise Several theories link the etiology of Low Back Pain clinical signs and symptoms to the mechanical instability of the lumbar spine. Stability of the lumbar spine requires both passive stiffness, through the osseous and ligamentous structures, and active stiffness, through "core" muscles, such as rectus abdominis, external oblique, internal oblique, transversus abdominis, quadratus lumborum, multifidi, psoas major, iliocostalis, gluteus major. It has been shown that therapeutic exercise improves vertebral stability through stretching and strengthening of "core" muscles, but also by enhancing neuromuscular proprioceptive facilitation. This is the reason why physical exercise programs usually do include strengthening and trunk-stabilizing exercises. 5. Joba® Core Trainer Joba® Core Trainer is a gym equipment which makes use of the counterbalance principle to efficiently engage trunk muscles, including both abdominals and trunk extensors. This equipment has been proved to be effective in improving cardio-respiratory fitness level, increasing resting energy expenditure, reducing weight and enhancing glycaemic control in diabetic patients. Furthermore it significantly strengthens diverse muscular groups (abdominals, trunk extensors, abductors, thigh flexors and extensors).

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of low back pain (back pain, felt between the bottom edge of the costal arch and the inferior gluteus fold)
  • Chronic (with symptoms that persist for more than 12 weeks)
  • Not specific (i.e. not caused by specific pathophysiological mechanisms, such as infections, fractures, tumors, spinal canal stenosis)
  • With or without irradiation of the sciatic nerve

排除标准

  • Spondylolisthesis > First Instance
  • Osteoporosis with vertebral collapse
  • Herniated discs expelled for less than 6 months
  • Herniated discs with an indication for surgical treatment
  • Facet joint syndrome, high grade
  • Previous surgery to stabilize the spine in any section
  • Conditions that contraindicate the practice of physical exercise
  • Neuro-sensory limitations (blindness, deafness) that hinder the practice of physical exercise or communication (speech disorder)
  • Cognitive impairment
  • Diagnosis terminal
  • Change of residence over the next four months

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验