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
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
The control group will continue in their current sitting arrangement during the same 3
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
Multiple sessions of 3-week intervals of data collection may be performed as needed to
achieve desired subject number in the study.
1. Individuals with a history of 1 or more episodes of low back pain (LBP) in the last
calendar year or who currently has LBP without radiation of pain from the low back
into the legs.
2. Males or Females who are 20-65 years of age.
3. Individuals who engage in work that requires sitting at a desk or computer 25 or more
hours a week.
4. Individuals who plan to work full time for each of the 3 weeks of the trial (April.
22 - May. 14, 2015), with no planned business travel or time off.
5. Individuals who can commit to attending two 1-1.5 hours data collection events
(appointments times from 4:30-8:30 pm): Either on: Wed. April 22, 2015 and Wed May
13, 2015 or Thurs. April 23, 2015 and Thurs. May 14, 2015 at a location on the west
side of Ann Arbor, MI.
6. Individuals who can read, write and understand English fluently. (Questionnaires are
7. Individuals who, while maintaining upright sitting, can lift their knee approximately
3-6 inches off the chair (as in marching), one at a time, on both sides.
8. Individuals who are willing to wear non-binding or flexible clothing around their
hips and pelvis at work during the three weeks of the trial if chosen to be in the
experimental group. Note: Because the posture device being studied tilts the user's
pelvis more upright, compared to the common slump / backward pelvic tilt that occurs
in sitting, some find, especially males , that this binds them in the front of their
pelvis and groin area when their clothing is tight or restrictive. Looser or flexible
clothing has significantly aided in tolerance of this positioning and will be
recommended if subject is chosen to be in the experimental group, assigned to use the
1. Individuals who currently have pain radiating from low back into the legs below hips.
2. Individuals with a history of low back surgery that includes:
- Spinal Fusion at any level
- Placement of any plates or screws in the low back (Note: those with a history of
back surgery > 1 year ago that did not involve plates or screws and are not
under medical restrictions associated with their back will be accepted.)
3. Individuals who have had any kind of lumbar surgery within the last calendar year.
4. Individuals with a currently painful coccyx area or a history of broken coccyx (or
tailbone) less than 1 year ago.
5. Individuals with a history of total hip replacement in the last year.
6. Individuals with significantly limited and painful back backward bending.
7. Anyone with known lumbar anterolisthesis (or forward slippage of 1 vertebra on
another) > grade 1
8. Anyone believing they may be more than 2 months pregnant at the time of the study.
9. Anyone who is not able to lie on their stomach for any reason.
10. Anything not listed above but known to subject that makes them believe they will be
unable to meet the requirements of the study as outlined.