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LOUIS
Global Changes Associated With Sacroiliac Joint Dysfunction and Its Reversal by Manipulation - A Randomized Controlled Trial
Sponsor study identifier
interventional
90
1 country
1
Study Start
February 10, 2025
Actual (reported)Primary Completion
March 31, 2025
Actual (reported)Study Completion
March 31, 2025
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 26, 2024
Actual (reported)November 29, 2024
Actual (reported)February 10, 2025
Actual (reported)March 31, 2025
Actual (reported)March 31, 2025
Actual (reported)Subjective Pain Assessment
Pain will be assessed with the Visual Analogue Scale (VAS), a horizontal line graded 0 (better outcome) to 10 (worse outcome).
From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Algometry Pain Assessment
Pressure algometer
From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Single-leg balance
Assess single-leg balance with a force platform
From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Gait parameters
Assess gait parameters with G-Walk, a wearable inertial sensor for motion analysis
From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Global perception of change and satisfaction with treatment
PGIC ( Patient Global Improvement Change Scale ) - is an instrument for measuring and evaluating the global perception of change and satisfaction with treatment, used in any health condition, unidimensional, with a scoring system on a positive orientation scale from 1 to 7, with a completion time of 1 minute\*.
Experimental group, subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018).
Sham group, subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group.
Control group, which will not be subject to any intervention.
The participants will receive one session of manipulation if in the experimental group. It should be mentioned that the technique will be carried out by a physiotherapist with a history of more than 10 years of manual therapy. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation a thrust will be executed.
Aveiro University
Aveiro, 3810-193, Portugal
90 participants (actual enrollment reported by the registry).
First Submitted
November 26, 2024
First Posted
November 29, 2024
Study Start
February 10, 2025
Actual (reported)Immediately after the last treatment
The participants will receive one session of sham manipulation if in the sham group. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation, the physiotherapist will pretend to execute a thrust.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2025
Actual (reported)Study Completion
March 31, 2025
Actual (reported)Last Updated
April 9, 2025
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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