Trial Outcomes & Findings for Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting (NCT NCT02420093)
NCT ID: NCT02420093
Last Updated: 2017-05-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Baseline and 3 Weeks
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
Baseline characteristics by cohort
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 WeeksThis 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.
Outcome measures
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
|---|---|---|
|
Change in Modified Oswestry Low Back Pain Disability Index
|
-8.25 units on a scale
Standard Error 1.62
|
-0.86 units on a scale
Standard Error 1.43
|
PRIMARY outcome
Timeframe: Baseline and 3 WeeksThis 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.
Outcome measures
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
|---|---|---|
|
Change in Left and Right Hamstring Length Testing
Left Hamstring
|
4.79 degrees
Standard Error 4.95
|
0.19 degrees
Standard Error 1.89
|
|
Change in Left and Right Hamstring Length Testing
Right Hamstring
|
1.71 degrees
Standard Error 4.41
|
2.38 degrees
Standard Error 3.06
|
PRIMARY outcome
Timeframe: Baseline and 3 WeeksThis 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.
Outcome measures
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
|---|---|---|
|
Change in Sorenson Test for Lumbar Muscle Endurance
|
5.88 time in seconds
Standard Deviation 2.19
|
4.07 time in seconds
Standard Deviation 2.68
|
PRIMARY outcome
Timeframe: Baseline and 3 WeeksThis 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.
Outcome measures
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
|---|---|---|
|
Change in Fingertip to Floor Flexibility Test
|
1.25 centimeters
Standard Error 0.94
|
0.71 centimeters
Standard Error 1.60
|
PRIMARY outcome
Timeframe: Change from Baseline after 3 WeeksThis 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".
Outcome measures
| Measure |
Experimental Group
n=8 Participants
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.
|
Control Group
n=7 Participants
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
|
|---|---|---|
|
Change in Numeric Pain Rating Scale
|
-1.5 units on a scale
Standard Error 0.433
|
-0.18 units on a scale
Standard Error 0.34
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Connors, PT, DScPT, OMPT
University of Michigan Health System
Phone: 734-763-6464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place