NCT06710535: LOUIS

Sacroiliac Joint Dysfunction Consequences and Its Reversal by Manipulation

Completed NA Last updated 9 April 2025

What this trial tests

NA trial testing Manual Manipulation in Sacroiliac Dysfunction in 90 participants. Completed in 31 March 2025.

Timeline

10 February 2025

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	Aveiro University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	10 February 2025
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across Portugal

Drugs / interventions tested

• Manual Manipulation
• Sham Manipulation

Conditions studied

• Sacroiliac Dysfunction — all drugs for Sacroiliac Dysfunction →

Sponsor

Aveiro University

Who can join

Adults 18 to 30, any sex, with Sacroiliac Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, the investigators 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, balance and gait ;
2. To try to understand the immediate, global and short-term effect of ASI manipulation, studying the cumulative effect of six sessions and the possible interrelationship between the changes recorded.

\- Study design Quantitative, with experimental study design, RCT, with the sample comprising individuals with SIJ dysfunction, where all participants in study 2 will be randomly allocated to the experimental, control and placebo groups. It will be carried out at the University of Aveiro facilities.

Initially, the investigators will map the changes present at a physical level, followed by manipulation, evaluating the immediate effect, measuring the degree of pain, unipodal balance and satisfaction with the treatment.

The investigators will then evaluate the effect of 3 sessions, on a weekly basis, for 3 weeks.

\- Material and methods

The investigators will make use of:
* Standing flexion test, to define the laterality of the dysfunction;
* VAS , to subjectively assess pain;
* Pressure algometer, to objectively assess pain ;
* Force Platform, to assess balance;
* G-Walk, for gait assessment;
* PGIC, to assess satisfaction with treatment ;

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.