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临床试验/NCT06687148
NCT06687148已完成不适用

Global Changes Associated With Sacroiliac Joint Dysfunction and Its Reversal by Manipulation - Pilot Study

Aveiro University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Pain

研究概览

简要总结

  • Summary Sacroiliac joint dysfunction (ASI) is an alteration in the normal biomechanics of the joint, which leads to hypomobility or hypermobility of that joint. It is one of the most common causes of misdiagnosis in low back pain and when not treated correctly, it often evolves into chronic pain (30% to 42%) and disability. Manipulating the dysfunctional ASI appears to result in benefits and significantly positive changes at various levels, in all segments of the human body. With this investigation, we intend to clarify and deepen the possible correlation between the changes that normally accompany this dysfunction, as well as its possible reversibility with its normalization.
  • Objectives

The investigators will essentially have two main objectives:

  1. Mapping of the most evident symptomatic changes, when sacroiliac joint dysfunction is present, in terms of pain and muscle tone;
  2. To try to understand the immediate, global and immediate effect of ASI manipulation.
  • Study design Quantitative, with experimental study design, with the sample comprising individuals with SIJ dysfunction, where all participants will be randomly allocated to the experimental, control and sham groups. It will be carried out at the University of Aveiro facilities.

Initially, we will assess the participants with sacroiliac dysfunction. The experimental will be manipulated, the control group will do nothing, and the sham group will be submitted to a hypothetical manipulation (sham manipulation). Consequently, the patients will be assessed again, measuring the subjective and objective degree of pain and muscle tone.

- Material and methods

We will make use of:

  • Standing flexion test;
  • Sitting Flexion Test;
  • Faber Test;
  • EVA , to subjectively assess pain;
  • Pressure algometer, to objectively assess pain ;
  • MyotonPro, to assess muscle tone;

详细描述

Introduction

ASI dysfunction refers to a state of altered biomechanics of this joint . This dysfunction can result from repetitive stress , degeneration, lumbar deformities, inflammation, and previous lumbar fusion.

ASI dysfunction is an alteration in the normal biomechanics of the joint, which leads to hypomobility or hypermobility of that joint. It is one of the most common causes of misdiagnosis in low back pain and when not treated correctly, it often develops into chronic pain (30% to 42%) and disability.

The SIJ has a crucial function in mobility, stability and resistance against shear forces, and is also wrongly undervalued as the origin of low back pain and, with the increase in average life expectancy, it has become an extremely prevalent problem.

Manipulation of the SIJ in dysfunction appears to bring about benefits and significantly positive changes at various levels. The analysis of the results of two manipulative therapy techniques in patients with sacroiliac dysfunction revealed a statistically significant improvement immediately after treatment, after 48 hours and one month later, in terms of both pain and disability, as favourable developments were recorded in measurements using the VAS and the Oswestry Disability Index (ODI).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of sacroiliac joint dysfunction.

排除标准

  • Students of the Bachelor's Degree in Physiotherapy;
  • Individuals with neurological injuries:
  • Under the effect of local anesthetics;
  • Subject to another type of therapeutic intervention, during the intervention period.

研究组 & 干预措施

Manipulative therapy

Experimental

Experimental group, subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018).

干预措施: Manual manipulation (Other)

Participants will be submitted to a simulated manipulation.

Sham Comparator

Sham group, subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group.

干预措施: Sham manipulation (Other)

Group will not be subject to any intervention.

No Intervention

Control group, which will not be subject to any intervention.

结局指标

主要结局

Pain

时间窗: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week

Pain will be assessed with the Visual Analogue Scale (VAS), with a horizontal line graded 0 (no pain) to 10 (worse pain).

Myotonometric assessment of muscular tonus

时间窗: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week

The investigators measure the muscle tone with the device Myoton Pro

Pain assessment with algometry

时间窗: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week

Pressure algometer

Pain intensity assessed using the Visual Analogue Scale (VAS)

时间窗: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week

Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).

Passive muscle mechanical properties assessed using MyotonPRO

时间窗: Immediately before and immediately after the intervention.

Passive muscle mechanical properties were assessed using the MyotonPRO, including muscle tone (frequency), stiffness, and logarithmic decrement.

Pressure Pain Threshold (PPT) assessed using pressure algometry

时间窗: Immediately before and immediately after the intervention.

Pressure pain threshold (PPT) was assessed using the Commander™ pressure algometer (JTECH Medical) at the predefined anatomical sites.

次要结局

未报告次要终点

研究者

发起方
Aveiro University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luís Filipe Albuquerque

Principal Investigator

Aveiro University

研究点 (2)

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