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临床试验/NCT04778215
NCT04778215已完成不适用

Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
2
主要终点
Weekly prevalence of LBP from baseline to end of the intervention program

研究概览

简要总结

Specific stabilization training targeting the deep trunk muscles has shown good effect in the rehabilitation of Low Back Pain (LBP) in young female TeamGym (TG) gymnasts. However, if this training can prevent LBP in this young population remains to be investigated. The aim of the present study was to investigate if a specific lumbar stabilization program can reduce and prevent LBP in young female TG gymnasts.

详细描述

Objectives: To study if a progressive specific lumbar stabilization program can reduce and prevent low back pain (LBP) in young female TeamGym (TG) gymnasts aged 10-16 years.

Design A cluster randomized controlled intervention study

Participants: All available competitive youth female TG teams including gymnasts aged 10-16 years, in the area of Stockholm, were invited to participate in the present study. A team consists of approximately 16 gymnasts. Fourteen out of 17 teams and a total of 258 gymnasts accepted to participate. Gymnasts and parents were informed about the study and written consent was collected. A cluster randomization process was undertaken as follows: the gymnasts in each team answered questions at inclusion and the teams were matched with respect to age, level of competition, amount of training sessions per week and reports of LBP. LBP in this study was defined as; "pain between the 12th rib and the gluteal fold". Thereafter a cluster randomization took place. This means that all gymnasts in one team were either in the control or in the intervention group. There were no differences with respect to demographic and training data and reports of LBP between the two groups at randomization. Ninety gymnasts did not report LBP at inclusion or during baseline and were included in a subgroup analysis on the preventive effect of the exercise program.

Methods Every week the gymnasts were visited by a registered physical therapist (RPT). The RPT answered questions from the gymnasts concerning injuries and collected a weekly-based questionnaire. The gymnasts in the intervention group were instructed to perform an eight-week progressive specific lumbar stabilization program, implemented in the warm-up at every training session. The gymnasts answered a weekly based questionnaire regarding training and LBP during the intervention period, and thereafter a questionnaire at 3-, 6- and 12 months follow-up. The gymnasts and the coaches were also instructed to continue with the lumbar stabilization program after the intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • female TeamGym teams, aged 10-16 years, in the Stockholm area
  • competing at national or international level

排除标准

  • male TeamGym gymnasts
  • female TeamGym teams on a regional competitive level

结局指标

主要结局

Weekly prevalence of LBP from baseline to end of the intervention program

时间窗: 3 months

Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group

Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program

时间窗: 3 months

Number of gymnasts reporting LBP 3 days or more or modification of participation (SLBP)/ Total number of gymnasts' reports; comparing the intervention and control group

Prevalence of LBP at 3-, 6- and 12 months follow up

时间窗: 18 months

Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group

次要结局

  • Change of Intensity and prevalence of LBP in gymnasts that report SLBP at the start of the study - from baseline to end of intervention, and at 3-, 6- and 12 months follow-up(18 months)
  • Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months(18 months)

研究者

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

Marita Löfgren Harringe

PhD

Karolinska Institutet

研究点 (2)

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