Low Back PainNCT02420093

Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

A study testing "Pelvis Support Assembly" in people with Low Back Pain and Strain; Postural, run by Oakland University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Low Back Pain, Strain; Postural
What is being tested?: "Pelvis Support Assembly"
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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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Trial locations and contacts

1 site in 1 country.

United States1 site

Gladwin Center
Ann Arbor, Michigan, 48103

Other trials in United States

About this study

Read the 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.

Conditions: Low Back Pain, Strain; Postural
Being tested: "Pelvis Support Assembly"
Medical subject headings: Low Back Pain, Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"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.

Study groups in NCT02420093
Study group	Role	What they receive
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. Receives: Device: "Pelvis Support Assembly"
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Change from Baseline after 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted17 Apr 2015 (estimated)
Study startJan 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02420093
Sponsor's protocol ID: IRBnet # 679149-4
Status last verified: Nov 2016
First submitted: 23 Jan 2015
Last updated: 22 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: There is no plan to make individual participant data (IPD) available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
ClinicalTrials.gov ID: NCT02420093
Acronym / sponsor ID: IRBnet # 679149-4
Conditions: Low Back Pain, Strain; Postural
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Oakland UniversityUniversity, hospital or other
Study start: Jan 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Posted 21 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental Group	Experimental	Device: "Pelvis Support Assembly"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

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"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.	Device	Experimental Group

Primary outcome

Change in Modified Oswestry Low Back Pain Disability Index
Time frame: Baseline and 3 Weeks
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
Time frame: Baseline and 3 Weeks
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
Time frame: Baseline and 3 Weeks
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
Time frame: Baseline and 3 Weeks
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
Time frame: Change from Baseline after 3 Weeks
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".

Results and safety

Results posted to the registry on 21 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	9	8
Control Group	8	7

Primary outcome: Change in Modified Oswestry Low Back Pain Disability Index

Time frame: Baseline and 3 Weeks. Mean (Standard Error). Unit: units on a scale

Measure	Experimental Group n = 8	Control Group n = 7
Value	-8.25 (1.62)	-0.86 (1.43)

Primary outcome: Change in Left and Right Hamstring Length Testing

Time frame: Baseline and 3 Weeks. Mean (Standard Error). Unit: degrees

Measure	Experimental Group n = 8	Control Group n = 7
Left Hamstring	4.79 (4.95)	0.19 (1.89)
Right Hamstring	1.71 (4.41)	2.38 (3.06)

Primary outcome: Change in Sorenson Test for Lumbar Muscle Endurance

Time frame: Baseline and 3 Weeks. Mean (Standard Deviation). Unit: time in seconds

Measure	Experimental Group n = 8	Control Group n = 7
Value	5.88 (2.19)	4.07 (2.68)

Primary outcome: Change in Fingertip to Floor Flexibility Test

Time frame: Baseline and 3 Weeks. Mean (Standard Error). Unit: centimeters

Measure	Experimental Group n = 8	Control Group n = 7
Value	1.25 (0.94)	0.71 (1.60)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 8 (0%)	0 of 8 (0%)	Not reported
Control Group	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia A Connors, MSPT principal investigator

Oakland University Doctoral Student

Melodie Kondratek, MS, DScPT study chair

Oakland University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing "Pelvis Support Assembly" in people with Low Back Pain and Strain; Postural, run by Oakland University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Oswestry Low Back Pain Disability Index (time frame: Baseline and 3 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.