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临床试验/NCT03571880
NCT03571880已完成不适用

Intra- And Inter-operator Reliability Of Isometric Back And Abdominal Muscle Strength Testing In Healthy Controls And Persons With Nonspecific Chronic Low Back Pain.

Hasselt University4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
4
主要终点
Back isometric strength

研究概览

简要总结

Low back pain (LBP) is currently the most common cause of functional impairment with regard to the musculoskeletal system1. LBP occurs in men and women in all age groups and has a peak incidence between 30 and 65 years. Although 10% of the persons with LRP can be diagnosed with a specific underlying pathology (e.g., disc herniation, canal stenosis, spondylolysis, ...), 90% have symptoms with an unclear origin. 23% of the latter group will eventually develop chronic nonspecific low back pain (CNSLBP)2.

Exercise therapy is seen as an important component in the rehabilitation of persons with CNSPLBP3. Because previous research showed reduced muscle strength of the back muscles4, exercise therapy that improves / recovers muscle strength is being investigated. However, there is still a lack of clarity concerning the effect that reduced muscle strength has on the development and further development of back pain5-6. The objective testing of back muscle strength remains a recurring issue. Up to now, back muscle strength has been mainly tested by a battery of clinical tests (eg Sorensen test) or the use of "iso machines"7. These Iso machines contain a dynamometer that can very specifically reflect the isometric or isokinetic force on an axis of rotation. Different types of these iso machines (eg Cybex, Biodex) have already been developed, each with specific designs (eg differences in the hip angle, differences in the stabilization of the participant). However, to date no standardized protocols are available for evaluating both abdominal and back muscle strength. Furthermore, it is also essential that before such systems can be used in clinical intervention studies, the reliability of such systems is investigated and that reference data from healthy subjects are collected with which data from patients can be compared.

The aim of the current research is therefore to investigate the intra- and inter-operator reliability of a standardized protocol drawn up according to the latest scientific evidence. A second goal is to set standard values for healthy persons for the developed protocol using the Biodex 3 dynamometer system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • medically diagnosed with non-specific chronic low back pain,
  • between 25-60 years old,
  • able to understand Dutch (spoken and written).

排除标准

  • invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
  • radiculopathy (uni- or bilateral),
  • co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, pregnancy,
  • ongoing compensation claims and/or (work)disability > 6 months,
  • rehabilitation/exercise therapy program for LBP in the past 6 months.

研究组 & 干预措施

CNSLBP group

Experimental

干预措施: Biodex-assisted isometric strength testing (Device)

Healthy control group

Active Comparator

干预措施: Biodex-assisted isometric strength testing (Device)

结局指标

主要结局

Back isometric strength

时间窗: day 2

The maximum voluntary isometric strength of the back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

Back dynamic strength

时间窗: day 2

The maximum voluntary dynamic strength of back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

Abdominal isometric strength

时间窗: day 2

The maximum voluntary isometric strength of the abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

Abdominal dynamic strength

时间窗: day 2

The maximum voluntary dynamic strength of abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

abdominal isometric strength

时间窗: day1

The maximum voluntary isometric strength of the abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

次要结局

  • Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)(day 1)
  • Pain(day 1)
  • The Modified Oswestry Disability Index (ODI)(Day 1)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annick Timmermans

Principal Investigator

Hasselt University

研究点 (4)

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