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

Not Applicable

Completed

• Conditions: Sacroiliac Joint Pain; Helath Related Quality of Life; Electromuscular Activation of the Pelis and Limbs; Ground Reaction Force Data
• Interventions: Device: Pelvic belt application

• Registration Number: NCT02027038
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2014-01
• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-01
• Last Update Submitted: 2014-01-01
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with sacroiliac joint pain	Pelvic belt application	Patients suffering from sacroiliac joint pain
Controls	Pelvic belt application	healthy controls

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Health related quality of life due to pelvic belt application	6 weeks	starting point: end of primary outcome measure ending point: 6 weeks