Gladwin Center
Ann Arbor, Michigan, 48103, United States
NCT Number: NCT02420093
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.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48103, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Use of a portable and adjustable "Pelvis Support Assembly" in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2.
Time frame: Baseline and 3 Weeks
This questionnaire measures the impact subject's low back pain on functional tolerance levels. Scale range is 0-100 with the lower score indicating a higher functional / activity level as it relates to Low Back Pain.
Time frame: Baseline and 3 Weeks
This test measures left and right hamstring length of the subject while they are lying on their back. The angle between the femur and tibia/fibula were measured when the hip angle held constant at 90 degrees and knee in full amount of available knee extension. This measure will use inclinometers for measurement.
Time frame: Baseline and 3 Weeks
This test measures a persons back strength in 1 repetition of holding a back posture in neutral as long as can while lying on their stomach, legs stabilized on a treatment table.
Time frame: Baseline and 3 Weeks
This test measures subjects flexibility in forward trunk bending while subject is standing on a block 20 cm high. Measurement is in centimeters from fingertip to edge of step, above or below the step edge.
Time frame: Change from Baseline after 3 Weeks
This questionnaire measures subjective perception of pain levels on a 0-10 (11 point) scale, with "0" being "no pain" and "10" being the "worst pain imaginable".
Oakland University
Other
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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