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临床试验/NCT03046472
NCT03046472已完成不适用

Physical Therapy Treatment Once a Month Versus Physical Treatment Once a Week for Posture Improvement in Children and Adolescents Who Suffer From Posture Problem or Low Back Pain

Assuta Hospital Systems2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月15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
Thoracic Kyphosis Angle

研究概览

简要总结

This study is design in a clinical setting for testing whether physical therapy treatment that includes postural awareness exercises for strength flexibility and endurance is improving low back pain and postural behavior. The study will consist of two groups, basic treatment that will get one on one treatment once a month for 3 months and the intervention group, will get an additional group therapy once a week.

详细描述

Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from 32% to 66%. This prevalence gets higher with age and among 17 years old it's equal to prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to the next one, hence we should do preventative care at a young age, even before the first attack occur. Poor posture was found as one of the risk factors for Low Back Pain in children. Adolescence with neutral posture had less prevalence of Low Back Pain then those with poor posture. Prolong slouch sitting was associated with Low Back Pain. Prevention education programs, focusing on knowledge, did not show effective change in posture behavior. Hence, the researchers concluded that it's better if they focus on exercise.

Research Goal: comparison between physical therapy treatment for good posture once a week versus once a month, on postural behavior, thorax curve angle and Low Back Pain.

Research type: randomize, Interventional, blinded. Methods and Procedures Population: the study will include 50 children and adolescents age 10-18 years suffering from poor back posture, with or without Low Back Pain.

Procedure: The study will consist of two groups: both groups will get personal meeting once a month and a program of exercising at home every day. Treatment group will have in addition group meeting once a week and control group not. The intervention program will include physical awareness and practice for good posture, and exercises for flexibility, strength and muscle endurance.

Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural observation for measuring postural habits. Back pain and postural habits questionnaire for measuring LBP on VAS SCALE, postural knowledge and habits of participant, including demographic data. Parents' questionnaire for measuring parents' knowledge and ideas.

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 (Investigator)

盲法说明

One of the investigators has the role of examining the participants before and after the intervention. She will be blinded from the group allocation.

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and Adolescent who referred by their pediatrician or orthopedic doctor to Physical Therapy treatment due to bad posture or Low Back Pain
  • At the Physical Therapy clinic was found that this is truly the condition of bad posture or low back pain with bad posture.
  • age 10-18 years
  • they signed on informed consent.

排除标准

  • Children and Adolescent who suffer from risk of structural deterioration as structural scoliosis(Cob angle above 20° and Risser sign equal or below 3) or structural Kyphosis (above 40° Risser sign equal or below 3 or Scheuermann Disease)
  • Any sever health condition neurologic internal or orthopedic like Cerebral Palsy, Juvenile rheumatoid arthritis or Malignancy.

结局指标

主要结局

Thoracic Kyphosis Angle

时间窗: 2 time points. before starting intervention and after 3 months.

Normal thoracic kyphosis angle ranges between 25°-40°. Measuring by Digital Inclinometer by placing it on the spinous process of T1 and T12 and the outcome off subtraction the two numbers is our out come. The participant is to stand how ever he think is the best posture.

Low Back Pain

时间窗: 2 time points. before starting intervention and after 3 months.

VAS Scale 0-10 0 no pain 1-2 very mild pain 2-3 mild pain 4-6 moderate pain 7-8 high pain 9-10 very high pain

Back Postural Behavior

时间窗: 2 time points. before starting intervention and after 3 months.

the investigator observes the participant in 8 different positions: sitting in the waiting room, walking to the treatment room, sitting in front of the therapist, placing a mattress on the floor, exercising in six position, exercising in sitting position, exercising in standing position, and changing between positions. Each position get a subscore as 0-bad posture 1-fair 2-good. Overall postural behavior: was comprised of all 8 observations including: grades 0 to 16. An higher score is a better behavior. spontaneous behavior was comprised of 4 sob score that ha a spontaneous characteristics: sitting waiting for treatment, walking into the room, sitting during treatment and transition between exercises. summation of these 4 would range 0-8 . an Higher score is a better behavior.

次要结局

未报告次要终点

研究者

发起方
Assuta Hospital Systems
申办方类型
Other
责任方
Sponsor

研究点 (2)

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