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Completed

NCT Number: NCT02027038

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic belt application

Device

Primary outcomes

  1. Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome

    Time frame: 3-5 hours

    First application of pelvic belt = starting point No compression, moderate and maximum compression Health survey completion = end point

Secondary outcomes

  1. Health related quality of life due to pelvic belt application

    Time frame: 6 weeks

    starting point: end of primary outcome measure ending point: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Bauerfeind AG, Zeulenroda-Triebes

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 3, 2014
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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