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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Notify MeKey information
Conditions
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
Primary outcomes
-
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
-
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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