Association of Biomechanical Changes and Weight Gain Throughout Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natalie Wessel, Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01315860
First received: March 14, 2011
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

Low back and posterior pelvic pain are common in pregnant females. Previous studies have demonstrated disability and it is estimated that all women experience some degree of musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females have temporarily disabling symptoms.

There is demonstrated controversy over the mechanism of low back pain in pregnancy. The biomechanical theory implies that the enlarging uterus causes the maternal center of gravity to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight gain correlated with biomechanical changes. The changes were measured by weight gain in segmental regions of the body and in principal moments of inertia from the sit to stand movement. Literature does not demonstrate a specific correlation between weight gain and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three measurements may have a correlating effect on the underlying cause of low back pain in pregnant women.

This study aims to determine the correlation between weight gain of pregnant females and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center of gravity.


Condition Intervention
Low Back Pain
Pregnancy
Other: Postural Analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Biomechanical Changes and Weight Gain Throughout Pregnancy

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Weight Gain [ Time Frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks ] [ Designated as safety issue: No ]
    Amount of weight gain over the 2nd and 3rd trimester in lbs.


Secondary Outcome Measures:
  • Degree of Low Back Pain [ Time Frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks ] [ Designated as safety issue: No ]
    Degree of Low Back Pain as measured by the Oswestry Low Back Pain Scale.

  • Sway Rate [ Time Frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks ] [ Designated as safety issue: No ]
    The rate (in mm/s) that subject sways while standing still for 15 seconds.

  • Deviation of Center of Mass [ Time Frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks ] [ Designated as safety issue: No ]
    The degree of weight in percentage and lbs. that shifts anterior or posterior.

  • Lumbosacral Angle [ Time Frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks ] [ Designated as safety issue: No ]
    Degree of lumbosacral angle as measured by an inclinometer.


Enrollment: 28
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant Females
Pregnant females in their second or third trimester that meet the inclusion and exclusion criteria.
Other: Postural Analysis
Measure the subject's weight, sway rate and shift of center of gravity on a postural scale for 15 seconds. Measure lumbosacral angle with an inclinometer.

Detailed Description:

The principal investigator will recruit subjects at the yoga studio and one of the investigators and the research assistant will recruit subjects at the NSU clinic. Potential subjects will go through a short verbal pre-screening to ensure they fit the inclusion and exclusion criteria. Subjects that fit this criteria will read and sign the consent form. The PI and research assistant will answer any questions about the study prior to the subject giving consent.

Then the subject's initial weight will be measured on the postural scale and documented. Change in weight is the dependent variable in this study. The following independent variables will be measured: lumbosacral angle, sway rate and shift of weight posteriorly. The lumbosacral angle will be measured by a digital inclinometer. The lumbosacral angle is measured between the plane of the superior surface of S1 to the horizontal plane. Saur et. al., demonstrated that the inclinometer technique for lumbosacral angle has established validity and reliability in comparison to radiographic x-rays. Comparison of radiographic and inclinometer technique is clinically suitable for measuring lumbar position. Keeley et. al. reported high correlation coefficients for interrater reliability with the inclinometer technique on patients with chronic low back pain.

The additional measurements of sway rate and center of gravity will be measured by the postural analyzer. The quadruple scale that will be used in this study is based on four digital force plates with computer communication operated by software enabling test analysis. The quadruple scale will provide numeric and graphic data on total weight, weight distribution (kg. or lb.), percentage weight difference, sway rate and an estimate of the location and deviation of the subject's center of mass. All data will be recorded and saved.

Following those measurements, the subject will be asked to complete the Oswestry Low Back Pain Scale. The Oswestry Low Back Pain Scale is a suitable questionnaire for an English-speaking population and to enquire about areas of functioning specifically relevant to low back pain sufferers, such as lifting, walking, sitting, standing, sleeping and socializing. Fisher et. al. demonstrated that the Oswestry Low Back Pain Scale is an acceptable instrument for back pain patients with evidence of criterion-related validity, factorial validity and moderately high internal consistency. It has good face validity for the patients. According to Fisher et. al., the Oswestry Scale can be recommended as a relevant measure of disability with evidence of validity, reliability and sensitivity to change for both clinical and research purposes.

The total amount of time needed to complete the measurements and the Oswestry Low Back Pain Scale should take 15 minutes. Biweekly, willing participants will be recruited and previous participants will be continually measured for weight, lumbosacral angle, sway rate and deviation of the subject's center of mass.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant females in their second or third trimester.

Criteria

Inclusion Criteria:

  • Pregnant patients in their second or third trimester who are patients at NSU Ob/Gyn clinic or prenatal yoga students at Red Pearl Yoga Studio who are willing to participate in the study and follow up with measurements for three months.

Exclusion Criteria:

  • Exclusion criteria include women who have a BMI of over 30 or whom are clinically obese.
  • Abdominal obesity can cause low back pain and it increases the lumbosacral angle.
  • Women will be excluded who have prior history of back surgery, acute disc herniation, arthritis, immunological disorder, acute fracture and osteoporosis.
  • Additional exclusion criteria include high risk pregnancies such as gestational diabetes, preeclampsia, placenta previa and abruptio placentae.
  • All of the following could be contributory for low back pain and may affect the biomechanics of the low back.
  • If the patients at the NSU clinic have these exclusion criteria documented in their medical chart, they will not be approached for recruitment in the study. During the verbal pre-screening, the research assistant will ask the subject if they have any of the above conditions. If so, they will not be eligible to participate in the study. The same verbal pre-screening will be used at the yoga studio for recruitment. No data will be collected for subjects who are excluded during the pre-screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315860

Locations
United States, Florida
Nova Southeastern University Ob/Gyn Clinic
Fort Lauderdale, Florida, United States, 33314
Red Pearl Yoga Studio
Fort Lauderdale, Florida, United States, 33304
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Natalie Wessel, OMS3 Nova Southeastern University College of Osteopathic Medicine
  More Information

No publications provided

Responsible Party: Natalie Wessel, OMS III, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01315860     History of Changes
Other Study ID Numbers: 01111110Exp.
Study First Received: March 14, 2011
Last Updated: June 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Low Back Pain
Pregnancy
Biomechanics

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Weight Gain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on July 23, 2014