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Clinical Trials/NCT06687148
NCT06687148CompletedNot Applicable

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

Aveiro University2 sites in 1 country21 target enrollmentStarted: February 19, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
2
Primary Endpoint
Pain

Study Overview

Brief Summary

  • 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;

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Clinical diagnosis of sacroiliac joint dysfunction.

Exclusion Criteria

  • 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.

Arms & Interventions

Manipulative therapy

Experimental

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

Intervention: 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.

Intervention: Sham manipulation (Other)

Group will not be subject to any intervention.

No Intervention

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

Outcomes

Primary Outcomes

Pain

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aveiro University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luís Filipe Albuquerque

Principal Investigator

Aveiro University

Study Sites (2)

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