Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

Completed · Not applicable

Conditions studied: Low Back Pain, Strain; Postural

In brief

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.

Key facts

Study ID

NCT02420093

Run by

Oakland University

People needed

17

Starts

2015-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-22

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Males or Females who are 20-65 years of age.
• Individuals who engage in work that requires sitting at a desk or computer 25 or more hours a week.
• 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.
• 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.
• Individuals who can read, write and understand English fluently. (Questionnaires are in English)
• 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.
• 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 device.

You may not qualify if…

• Individuals who currently have pain radiating from low back into the legs below hips.
• 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.)
• Individuals who have had any kind of lumbar surgery within the last calendar year.
• Individuals with a currently painful coccyx area or a history of broken coccyx (or tailbone) less than 1 year ago.
• Individuals with a history of total hip replacement in the last year.
• Individuals with significantly limited and painful back backward bending.
• Anyone with known lumbar anterolisthesis (or forward slippage of 1 vertebra on another) > grade 1
• Anyone believing they may be more than 2 months pregnant at the time of the study.
• Anyone who is not able to lie on their stomach for any reason.
• 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.

Where it is running

• Gladwin Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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