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Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

Primary Purpose

Low Back Pain, Strain; Postural

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

"Pelvis Support Assembly"

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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Sites / Locations

Gladwin Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

The experimental group will use the "Pelvis Support Assembly" per US Patent number US 8,857,906 B2, in the seat of their 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.

The control group will not use the "Pelvis Support Assembly" per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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".

Secondary Outcome Measures

Full Information

NCT ID

NCT02420093

First Posted

January 23, 2015

Last Updated

April 9, 2017

Sponsor

Oakland University

1. Study Identification

Unique Protocol Identification Number

NCT02420093

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oakland University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Strain; Postural

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

The control group will not use the "Pelvis Support Assembly" per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval

Intervention Type

Device

Intervention Name(s)

"Pelvis Support Assembly"

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Modified Oswestry Low Back Pain Disability Index

Description

Time Frame

Baseline and 3 Weeks

Title

Change in Left and Right Hamstring Length Testing

Description

Time Frame

Baseline and 3 Weeks

Title

Change in Sorenson Test for Lumbar Muscle Endurance

Description

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.

Time Frame

Baseline and 3 Weeks

Title

Change in Fingertip to Floor Flexibility Test

Description

Time Frame

Baseline and 3 Weeks

Title

Change in Numeric Pain Rating Scale

Description

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".

Time Frame

Change from Baseline after 3 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia A Connors, MSPT

Organizational Affiliation

Oakland University Doctoral Student

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Melodie Kondratek, MS, DScPT

Organizational Affiliation

Oakland University

Official's Role

Study Chair

Facility Information:

Facility Name

Gladwin Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data (IPD) available

Learn more about this trial

Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

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