Global Changes Associated With Sacroiliac Joint Dysfunction

NCT06687148 | Not Yet Recruiting

• 1 other identifier: Global changes with SIJD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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:
• Mapping of the most evident symptomatic changes, when sacroiliac joint dysfunction is present, in terms of pain and muscle tone;
• 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;

Conditions

Sacroiliac Dysfunction

Keywords

manipulative intervention; pain; muscle tone; semiology of sacroiliac dysfunction

Outcome Measures

Primary Outcomes (3)

• Pain

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

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

• Myotonometric assessment of muscular tonus

  The investigators measure the muscle tone with the device Myoton Pro

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

• Pain assessment with algometry

  Pressure algometer

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

Study Arms (3)

Manipulative therapy

EXPERIMENTAL

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

Other: Manual manipulation

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.

Other: Sham manipulation

Group will not be subject to any intervention.

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.

Manipulative therapy

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.

Participants will be submitted to a simulated manipulation.

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of sacroiliac joint dysfunction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

Aveiro University

Aveiro, Aveiro District, 3810-193, Portugal

Location

Related Publications (3)

• Kamali F, Shokri E. The effect of two manipulative therapy techniques and their outcome in patients with sacroiliac joint syndrome. J Bodyw Mov Ther. 2012 Jan;16(1):29-35. doi: 10.1016/j.jbmt.2011.02.002. Epub 2011 Mar 11.

  PMID: 22196424 BACKGROUND

• Grieve E. Lumbo-pelvic rhythm and mechanical dysfunction of the sacro-iliac joint. Physiotherapy. 1981 Jun;67(6):171-3. No abstract available.

  PMID: 7301975 BACKGROUND

• Gartenberg A, Nessim A, Cho W. Sacroiliac joint dysfunction: pathophysiology, diagnosis, and treatment. Eur Spine J. 2021 Oct;30(10):2936-2943. doi: 10.1007/s00586-021-06927-9. Epub 2021 Jul 16.

  PMID: 34272605 BACKGROUND

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

Central Study Contacts

Luís F Albuquerque, PT

CONTACT

+351962970056; lfalbuquerque@ua.pt

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 12, 2024
• First Posted: November 13, 2024
• Study Start: April 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 12, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

PT (1)