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临床试验/NCT05264311
NCT05264311已完成不适用

Effect of a Pilates Exercise Program on the Flexion-relaxation Rate in Women With Chronic

University of Valencia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
FRR was calculated by dividing the maximal EMG amplitude during flexion by the minimum EMG amplitude at full flexion. The mean of the 3 trials performed was used to determine the FRR for each muscle for each subject.

研究概览

简要总结

The purpose of this study is to evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal is to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR.

详细描述

Purpose: To evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal was to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR. Material and methods: Thirty women with chronic LPB were randomly assigned to either PEP (EG, n=15) or control group (CG=15). EG followed an 8-week PEP while no specific intervention was carried out on the controls. Before and after this period all variables were recorded.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • lumbar or lumbosacral pain (with or without radicular pain) for at least six months;
  • a score higher than 6/50 on the Oswestry Disability Index (ODI)
  • absence of any back treatment for the last three months.

排除标准

  • body mass index > 30 kg/m2
  • prior surgery of the pelvis,
  • spinal column or lower extremity
  • scoliosis;
  • systemic or degenerative disease
  • history of neurological diseases or deficits not related to back pain
  • pregnancy or hypertension.

结局指标

主要结局

FRR was calculated by dividing the maximal EMG amplitude during flexion by the minimum EMG amplitude at full flexion. The mean of the 3 trials performed was used to determine the FRR for each muscle for each subject.

时间窗: 2 months

A lower FRR indicated a greater state of muscle relaxation. Asymmetry in muscle activity between both (right and left) ES muscles was calculated as their mean difference in RMS in the three flexion-extension tasks. Asymmetry in the FRR was calculated as the absolute difference between FRR of the right and left ES muscles.

次要结局

  • The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.(2 months)
  • A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity(2 months)
  • Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Romagnoli

Principal Investigator

University of Valencia

研究点 (2)

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