Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT02420093
Eligibility Criteria:
Inclusion Criteria:
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 in English)
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 device.
Exclusion Criteria:
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.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02420093
Study Brief:
Protocol Section:
NCT02420093