View Clinical Trial (Medical Research Study)
A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.
| City: |
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Portland |
| State: |
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Oregon |
| Zip Code: |
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97239 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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This study compares three treatments for low back pain that started during pregnancy. The
study hypothesizes that exercise, spinal manipulation, and a mind-body technique called
neuroemotional technique (NET) equally affect pain intensity and disability associated with
pregnancy-related low back pain. The study also hypothesizes that pain intensity and
disability levels do not influence maternal heart rate variability (a measure of stress) and
intrauterine attachment (a measure of relationship quality). Ten women will additionally
provide blood and salivary oxytocin samples during pregnancy and periodically for three
months after birth. These women and their babies will also be videotaped playing for 5
minutes at 2 weeks, 6 weeks, and 3 months postpartum.
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| Study Summary: |
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Pregnancy-related low back pain is experienced by over half of all pregnant women. In the
United States it is thought of as a normal constituent of pregnancy. However, in Europe low
back pain associated with pregnancy is treated. In the United States pregnancy-related low
back pain is thought to resolve with birth. However about 1/3 of women who experience
pregnancy-related low back pain continue to experience back pain for one year postpartum.
Those women whose low back pain persists into the postpartum period are more at risk of
experiencing comorbidities such as postpartum depression.
In the extrauterine life maternal pain limits a mother's ability to securely attach with her
child. Furthermore, interpretation of pain intensity is influenced by the type of attachment
the individual has with her parents. Little is known how maternal pain may influence
intrauterine attachment. Similarly, heart rate variability is influenced by pain and by
spinal manipulation in non-pregnant populations. However, normal non-pregnant patterns of
heart rate variability are altered during the second and third trimesters of pregnancy, and
little is known about why this happens or what this means.
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| Criteria: |
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Inclusion Criteria:
- Healthy
- 20-49 years old
- Pregnant with a singleton
- Low back pain began during pregnancy and has lasted more than one week
- Low back pain is reproducible with palpation
Exclusion Criteria:
- Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.
- Pain radiates below knee
- Cannot read English
- Plans to move away from Portland area during pregnancy
- Not willing to be randomized to one of the three arms of the study
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| NCT ID: |
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NCT00937365 |
| Primary Contact: |
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Principal Investigator
Thomas Gregory, MD
Oregon Health and Science University
Caroline D Peterson, DC, PhD
Phone: 503-367-1172
Email: petcarol@ohsu.edu
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| Backup Contact: |
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Email: gregoryt@ohsu.edu
Thomas Gregory, MD
Phone: 503-494-3107
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| Location Contact: |
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Portland, Oregon 97239
United States
Caroline D Peterson, DC, PhD
Phone: 503-367-1172
Email: petcarol@ohsu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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