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

Sacroiliac Joint Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027038
• Other study ID #: 063/11/07032011
• Status: Completed
• Phase: N/A
• First received: January 1, 2014
• Last updated: January 1, 2014
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Pelvic belt application

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Bauerfeind AG, Zeulenroda-Triebes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Health related quality of life due to pelvic belt application	starting point: end of primary outcome measure ending point: 6 weeks	6 weeks	No