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临床试验/NCT04765293
NCT04765293已完成不适用

The Effect of GRAVITY System Therapy on Chronic Low Back Pain in Disc Disease

Józef Piłsudski University of Physical Education2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

The aim of the study was to examine the effect of GRAVITY system therapy on chronic disc-related pain in lumbar spine. Investigators made a hypothesis that patients who regularly perform core strengthening exercises based on gravity system will decrease pain and disability, and increase muscle strength in higher extent comparing to control group, that receive passive physical therapy.

详细描述

GRAVITY therapy group had therapy twice a week for 4 weeks for 40 minutes that made 2x40 minx 4 weeks=320 minutes.

Clinical control group had standard, two weeks ambulant, every day, physical therapy sessions, 5 times a week 30 min, that is 10 sessions 30 min x10=300 min. So the total amount of treatment was comparable.

All participants in both groups completed the study. Investigators used the Oswestry Disability Index (ODI) to determine the disability level of patient with low back pain (Shah et al, 2016), and VAS scale (visual analogue scale) (0-10) to measure pain intensity.

The next stage of examination was the lumbopelvic complex stability test. The test comprised of several activities which had to be performed without lifting the lumbar region. The more difficult activity a patient was able to perform, the higher was assessed their muscle strength.

All the patients were examined twice:

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)

盲法说明

Outcomes Assessor was blinded concerning participants therapy model and results.

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with chronic, local low back pain
  • diagnosed with lumbar spinal disc disease confirmed with medical examination and anamnesis by a physiotherapist/ neurosurgeon; current MRI scan,
  • no history of spinal surgery,
  • no earlier physiotherapy

排除标准

  • other spinal dysfunctions
  • history of spinal surgery,
  • physiotherapy attendance before the start of the study

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

Visual Analogue Scale (0-10)

次要结局

  • Abdominal muscle strength(4 weeks)
  • Disability(4 weeks)

研究者

发起方
Józef Piłsudski University of Physical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Truszczynska Baszak

Assoc Prof

Józef Piłsudski University of Physical Education

研究点 (2)

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