Low Back Pain Clinical Trial
Official title:
Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
The aim of this study is to examine the clinical effects of supporting the human pelvis in a neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral sitting posture will be supported by a portable and adjustable "pelvic support device" or "pelvic support assembly" per US Patent number US 8,857,906 B2 that is used in the seat of the user's desk chair.
This study is a randomized control trial with repeated measures. It will include 34 subjects
with low back pain who sit 25 hours a week or more at a desk / computer.
There will be 2 groups: control and experimental, each with 17 subjects. All subjects will
be measured on the same 2 dates (3 weeks apart - pre and post intervention) with the same
measures.
The experimental group will use a pelvic support device, that aids in supporting the user's
pelvis in a neutral position, in their desk chairs at home or work as tolerated during this
3 weeks.
The control group will continue in their current sitting arrangement during the same 3
weeks.
For control of conflict of interest, the Sponsor-Investigator will not perform any of the
measures and data will be coded for subject group assignment until all data analysis is
finalized.
Multiple sessions of 3-week intervals of data collection may be performed as needed to
achieve desired subject number in the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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