Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces

Study Overview
=================
Brief Summary
-----------------
Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of limb muscles and ground reaction forces are different in patients with sacroiliac joint pain, as compared to healthy controls. Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the electromuscular activation of the limb muscles or ground reaction forces. Hypothesis III: The effects proposed in hypothesis II are different in patients with sacroiliac joint pain, as compared to healthy controls.

Detailed Description
-----------------
The sacroiliac joint is among the most frequently involved anatomical structure in low back pain. Pelvic belt anatomy makes the sacroiliac joint more vulnerable to be involved in chronic painful conditions. However, the anatomical and functional correlate of sacroiliac joint pain is yet undetermined. According to the guidelines of International Association for the Study of Pain (IASP), painful conditions should primarily be managed conservatively. However, existing studies fail providing sound evidence on the effects of conservative devices to therapy sacroiliac joint pain. In the study, a total of 17 patients suffering from sacroiliac joint pain and 17 controls were investigated by means of magnetic resonance imaging, EMG, health surveys and ground reaction force measurements. A pelvic compression belt was administered in two levels of compression and the corresponding magnetic resonance imaging, EMG and ground reaction force data were measured.

Conditions
-----------------
Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs, Ground Reaction Force Data

Intervention / Treatment
-----------------
* Device: Pelvic belt application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnostically confirmed sacroiliac joint pain controls without any history of musculoskeletal disorders Exclusion Criteria: endoprostheses, metallic implants somatoform disorders, claustrophobia, pregnancy surgical interventions on the spine, degenerative joint diseases elsewhere

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with sacroiliac joint pain<br>Patients suffering from sacroiliac joint pain | Device: Pelvic belt application<br> <br> |
| Active Comparator: Controls<br>healthy controls | Device: Pelvic belt application<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome | First application of pelvic belt = starting point No compression, moderate and maximum compression Health survey completion = end point | 3-5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life due to pelvic belt application | starting point: end of primary outcome measure ending point: 6 weeks | 6 weeks |