Low Back PainNCT01315860
Association of Biomechanical Changes and Weight Gain Throughout Pregnancy
An observational study of Low Back Pain and Pregnancy, run by Nova Southeastern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pregnancy
- What is being tested?
- Postural Analysis
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant females in their second or third trimester.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Red Pearl Yoga Studio
Fort Lauderdale, Florida, 33304
Nova Southeastern University Ob/Gyn Clinic
Fort Lauderdale, Florida, 33314
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Pregnancy
- Being tested
- Postural Analysis
- Keywords
- Low Back Pain, Pregnancy, Biomechanics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Females | Pregnant females in their second or third trimester that meet the inclusion and exclusion criteria. Receives: Other: Postural Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Amount of weight gain over the 2nd and 3rd trimester in lbs.
Measured: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Secondary outcomes (4)
Degree of Low Back Pain
Degree of Low Back Pain as measured by the Oswestry Low Back Pain Scale.
Measured: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Sway Rate
The rate (in mm/s) that subject sways while standing still for 15 seconds.
Measured: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Deviation of Center of Mass
The degree of weight in percentage and lbs. that shifts anterior or posterior.
Measured: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Lumbosacral Angle
Degree of lumbosacral angle as measured by an inclinometer.
Measured: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Wessel, Nova Southeastern University
- Investigators
- Natalie Wessel, OMS3, Principal investigator, Nova Southeastern University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315860
- Sponsor's protocol ID
- 01111110Exp.
- Status last verified
- Jun 2012
- First submitted
- 14 Mar 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Biomechanical Changes and Weight Gain Throughout Pregnancy
- ClinicalTrials.gov ID
- NCT01315860
- Acronym / sponsor ID
- 01111110Exp.
- Conditions
- Low Back Pain, Pregnancy
- Keywords
- Low Back Pain, Pregnancy, Biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Females | – | Other: Postural AnalysisPregnant females in their second or third trimester that meet the inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant females in their second or third trimester.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Postural AnalysisMeasure 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. | Other | Pregnant Females |
Primary outcome
Weight Gain
Time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Amount of weight gain over the 2nd and 3rd trimester in lbs.
4 secondary outcomes
Degree of Low Back Pain
Time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Sway Rate
Time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Deviation of Center of Mass
Time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Lumbosacral Angle
Time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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.
Natalie Wessel, OMS3 principal investigator
Nova Southeastern University College of Osteopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Pregnancy, run by Nova Southeastern University at 2 sites 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 1 inclusion and 6 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 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Gain (time frame: Every 2-3 weeks in 2nd and/or 3rd trimester for eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2012.