Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

Low Back Pain Clinical Trial

Official title:

Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02420093
• Other study ID #: IRBnet # 679149-4
• Status: Active, not recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: November 18, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: Oakland University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Strain; Postural

Intervention

Device:
• "Pelvis Support Assembly"
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.

Locations

Country	Name	City	State
United States	Gladwin Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Oakland University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Oswestry Low Back Pain Disability Index	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.	Baseline and 3 Weeks	No
Primary	Change in Left and Right Hamstring Length Testing	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.	Baseline and 3 Weeks	No
Primary	Change in Sorenson Test for Lumbar Muscle Endurance	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.	Baseline and 3 Weeks	No
Primary	Change in Fingertip to Floor Flexibility Test	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.	Baseline and 3 Weeks	No
Primary	Change in Numeric Pain Rating Scale	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".	Change from Baseline after 3 Weeks	No