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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Pelvis Support Assembly" | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Connors, MSPT | Oakland University Doctoral Student | Principal Investigator |
| Melodie Kondratek, MS, DScPT | Oakland University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gladwin Center | Ann Arbor | Michigan | 48103 | United States |
There is no plan to make individual participant data (IPD) available
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | 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. "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. |
| FG001 | Control Group | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | 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. "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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | 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. "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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Connors, PT, DScPT, OMPT | University of Michigan Health System | 734-763-6464 | pattyconnors219@gmail.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| BG001 | Control Group | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | 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 |
|
|
| 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. | Posted | Mean | Standard Error | degrees | Baseline and 3 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | time in seconds | Baseline and 3 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Error | centimeters | Baseline and 3 Weeks |
|
|
|
| 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". | Posted | Mean | Standard Error | units on a scale | Change from Baseline after 3 Weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control Group | 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 | 0 | 7 | 0 | 7 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |