Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting

NCT02420093 | Completed Results DMC

• 1 other identifier: IRBnet # 679149-4
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Strain; Postural

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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.

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

Interventions

"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.

Experimental Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oakland University: lead

Study Sites (1)

Gladwin Center

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Conditions

Low Back Pain; Sprains and Strains

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Patricia Connors, PT, DScPT, OMPT
• Organization: University of Michigan Health System

pattyconnors219@gmail.com

734-763-6464

Study Officials

• Patricia A Connors, MSPT

  Oakland University Doctoral Student

  PRINCIPAL INVESTIGATOR

• Melodie Kondratek, MS, DScPT

  Oakland University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patricia Connors - Doctoral Student

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: April 17, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 22, 2017
• Results First Posted: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)