Sacroiliac Joint Dysfunction Consequences and Its Reversal by Manipulation

NCT06710535 | Completed

• 1 other identifier: Aveiro University
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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, 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

• 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 ;

Conditions

Sacroiliac Dysfunction

Keywords

pain; single-leg static balance; Gait assessment; sacroiliac joint manipulation

Outcome Measures

Primary Outcomes (5)

• 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\*.

  Immediately after the last treatment

Study Arms (3)

Manual manipulation

EXPERIMENTAL

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

Other: Manual Manipulation

Sham Manipulation

SHAM COMPARATOR

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

Other: Sham Manipulation

Control Group

NO INTERVENTION

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

Interventions

Manual Manipulation OTHER

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.

Manual manipulation

Sham Manipulation OTHER

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.

Sham Manipulation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with sacroiliac joint dysfunction demonstrated
• Students of Aveiro University
• Aged between 18 and 30 years

You may not qualify if:

• Individuals with neurological injuries
• Subject to another type of therapeutic intervention, during the intervention period.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

Aveiro University

Aveiro, 3810-193, Portugal

Location

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: February 10, 2025
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-12

Locations

PT (1)