Association of Biomechanical Changes and Weight Gain Throughout Pregnancy

NCT01315860 | Completed DMC

• 1 other identifier: 01111110Exp.
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Low Back Pain; Pregnancy

Keywords

Low Back Pain; Pregnancy; Biomechanics

Outcome Measures

Primary Outcomes (1)

• Weight Gain

  Amount of weight gain over the 2nd and 3rd trimester in lbs.

  Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks

Secondary Outcomes (4)

• Degree of Low Back Pain

  Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks

• Sway Rate

  Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks

• Deviation of Center of Mass

  Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks

• Lumbosacral Angle

  Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks

Study Arms (1)

Pregnant Females

Pregnant females in their second or third trimester that meet the inclusion and exclusion criteria.

Other: Postural Analysis

Interventions

Postural Analysis OTHER

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.

Pregnant Females

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females in their second or third trimester.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• All of the following could be contributory for low back pain and may affect the biomechanics of the low back.

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (2)

Red Pearl Yoga Studio

Fort Lauderdale, Florida, 33304, United States

Location

Nova Southeastern University Ob/Gyn Clinic

Fort Lauderdale, Florida, 33314, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Natalie Wessel, OMS3

  Nova Southeastern University College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OMS III

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

US (2)