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临床试验/NCT04387032
NCT04387032已完成不适用

The Influence of the Sacroiliac Joint Manipulation on Changes in the Values of the Center of Pressure in the Process of Maintaining Static Body Balance

Poznan University of Physical Education2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年6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
59
试验地点
2
主要终点
COP X POST

研究概览

简要总结

The study can be identified as an experimental study with a quasi-randomized control. It consisted of HVLA manipulation on blocked sacroiliac joints (SIJ) and it was checked whether it affected the appropriate parameters determining the pressure center (COP). The value of the parameters were examined twice, before (PRE) and after (POST) manipulation. The results were compared with the control group (people without hypomobility SIJ) in which sham manipulation was performed, and COP parameters (PRE and POST) were measured twice. In addition, PRE and POST results were compared within the group, i.e. separately in the experimental group (E) and separately in the control group (C) to check the effect of HVLA manipulation and placebo manipulation.

The first hypothesis assumes that persons belonging to the experimental group are characterized by significantly higher values of COP parameters before manipulation than values in the control group. The second hypothesis assumes that COP parameters will normalize as a result of sacroiliac joint mobilization performed in the experimental group.

详细描述

The aim of the project was to determine the effectiveness of HVLA manipulation in maintaining static body balance. To implement it, it was necessary to conduct an experiment consisting in performing HVLA manipulation in people with SIJs hypomobility and checking whether it affects the COP parameters. It was assumed to measure these parameters twice (before (PRE) and after (POST) manipulation) and compare them with the measurements in the C group (sham manipulation).

The sample size necessary to power the study was determined at the test planning stage, using the G * Power 3.1.9 software. The standard threshold α = .05 was established; then the acceptable power level of the 1-β = .90 test and the expected moderate effect size η2 = .30 were determined for within-between interaction. The calculated total expected size of the sample is N = 32, i.e. 16 subjects in one research group, assuming that their number will not decrease during the study. With a higher test power 1-β = .95 and a moderate achieved result for observed effect size η2 = .25, the sample should have to consist of 26 subjects per subgroup. It was decided to examine a slightly larger number of available entities due to the possibility of excluding incorrect data.

Poznan University of Physical Education's students were invited to the research, electronically. Before starting the research, they were informed about the purpose and manner of conducting the research, and the type of methods used. Participation in the experiment was voluntary and free. Participants could withdraw from cooperation in the research at any time. They obtained assurance that the data obtained will be used only for scientific purposes and their processing will be fully anonymous.

Among 202 students of the Poznań University of Physical Education who responded to the invitation to the study project interview has been conducted, as a result of which 22 people were excluded from further actions due to disqualification criteria. Then sacroiliac mobility tests has been performed which made it possible to recognize hypomobility in 72 people. From the group of people with hypomobility, 36 people were randomly selected and included in the E group. From among people without hypomobility, 31 people were randomly selected for the C group. An random number table was used in the draw. The subjects did not know any group they were assigned to.

Subsequently, the examination of each project participant consisted of performing podometric measurements and SIJs mobilization in the E group or placebo in the C group, and re-performing functional tests and podometrics in both groups after the procedure. At the stage of analyzing data rejected 8 people who did not meet the assumed criteria, thus finally there were 30 people in the experimental group and 29 in the control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

blinded patient blinded researcher and person evaluating results

入排标准

年龄范围
19 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Student at the Poznan University of Physical Education;
  • age 19-24;
  • asymptomaticity in the form of no pain symptoms in the LS segment of the spine;
  • written consent to participate in the study;
  • presenting no disqualification criteria;
  • no health contraindications to perform manipulation;
  • no hypomobility of the SI joints, negative mobility test results PRE (to the control group);
  • occurrence of hypomobility of the SI joint on one or both sides PRE (to the experimental group);
  • noting the sound of cavitation during the procedure (in the experimental group);
  • confirmation of a treatment effectiveness by noting negative results of SI joints mobility tests POST (in the experimental group).

排除标准

  • Persons who were characterized by LBP, neurological symptoms, rheumatic problems, orthopedic, or ongoing treatment in the lumbar spine and pelvis area were excluded. Pregnancy and the anatomical difference in the length of the lower limbs exceeding 5mm were also an excluding criterion.

结局指标

主要结局

COP X POST

时间窗: POST (immediately after the intervention)

deflection of the COP in the X axis after manipulation

COP Y PRE

时间窗: PRE (immediately before the intervention)

deflection of the COP in the Y axis before manipulation

COP Length PRE

时间窗: PRE (immediately before the intervention)

path travelled by COP before manipulation;

COP Length POST

时间窗: POSt (immediately after the intervention)

path travelled by COP after manipulation;

COP Av.Q-speed POST

时间窗: POST (immediately after the intervention)

the average speed of COP after manipulation

COP X PRE

时间窗: PRE (immediately before the intervention)

deflection of the COP in the X axis before manipulation

COP Area PRE

时间窗: PRE (immediately before the intervention)

COP area before manipulation

COP Y POST

时间窗: POST (immediately after the intervention)

deflection of the COP in the Y axis after manipulation

COP Area POST

时间窗: POST (immediately after the intervention)

COP area after manipulation

COP Av.Q-speed PRE

时间窗: PRE (immediately before the intervention)

the average speed of COP before manipulation

次要结局

未报告次要终点

研究者

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

Małgorzata Waszak

Study Director

Poznan University of Physical Education

研究点 (2)

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