Clinical trial NCT02420093: Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
Official title: Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Strain; Postural
Lead sponsor: Oakland University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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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Primary outcomes:
measure: Change in Modified Oswestry Low Back Pain Disability Index
timeFrame: Baseline and 3 Weeks
measure: Change in Left and Right Hamstring Length Testing
timeFrame: Baseline and 3 Weeks
measure: Change in Sorenson Test for Lumbar Muscle Endurance
timeFrame: Baseline and 3 Weeks
measure: Change in Fingertip to Floor Flexibility Test
timeFrame: Baseline and 3 Weeks
measure: Change in Numeric Pain Rating Scale
timeFrame: Change from Baseline after 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Gladwin Center
state: Michigan
Study officials:
affiliation: Oakland University Doctoral Student
name: Patricia A Connors, MSPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Oakland University
name: Melodie Kondratek, MS, DScPT
role: STUDY_CHAIR
References: