Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment
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ClinicalTrials.gov Identifier: NCT00937365 |
Recruitment Status : Unknown
Verified July 2009 by Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : July 13, 2009
Last Update Posted : July 22, 2010
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Behavioral: Exercise Procedure: Spinal Manipulation Procedure: Neuroemotional Technique (NET) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain. |
Study Start Date : | July 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | March 2011 |
Arm | Intervention/treatment |
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Active Comparator: Exercise
Specific strengthening exercises demonstrated to improve pregnancy-related low back pain are taught to participants of this arm. Additionally, each participant will be evaluated and additional exercises will be prescribed relevant to her particular needs. Study participants of this arm are asked to perform the exercises at home at least once a day. Exercise is recorded in a diary. Participants follow the same study visit schedule as the two other arms.
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Behavioral: Exercise
Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
Other Names:
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Experimental: Spinal Manipulation
Women randomized to this arm will be evaluated for spinal subluxations and, if appropriate, treated with chiropractic manipulation. Type of manipulation is determined by presentation. Woman may be manipulated with high velocity low amplitude thrust, blocking, activator, or other appropriate means of manipulating.
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Procedure: Spinal Manipulation
Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
Other Names:
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Experimental: Neuroemotional technique (NET)
Neuroemotional technique (NET) is a mind-body technique which combines elements of chiropractic medicine, Chinese medicine, and behavioral psychology. Muscle response testing, a form of functional neurology, and visceral somatic reflexes are used to ascertain whether the pain or dysfunction experienced by the participant has an emotional component. If an emotional component is present, it is identified and the original "triggering" occurrence is identified. The participant creates a snapshot of that original occurrence and while she holds that image in her mind spinal levels which innervate the associated organ are adjusted.
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Procedure: Neuroemotional Technique (NET)
Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits.
Other Names:
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- Roland Morris Disability Index [ Time Frame: Last study visit prior to birth ]
- Pain Visual Analog Scale [ Time Frame: Last Study Visit Before Birth ]

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Ages Eligible for Study: | 20 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937365
Contact: Caroline D Peterson, DC, PhD | 503-367-1172 | petcarol@ohsu.edu | |
Contact: Thomas Gregory, MD | 503-494-3107 | gregoryt@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Caroline D Peterson, DC, PhD 503-367-1172 petcarol@ohsu.edu | |
Contact: Thomas Gregory, MD 503-494-3107 gregoryt@ohsu.edu | |
Sub-Investigator: Caroline D Peterson, DC, PhD | |
Principal Investigator: Thomas Gregory, MD |
Principal Investigator: | Thomas Gregory, MD | Oregon Health and Science University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Caroline Peterson, DC, PhD, MPH, CPM, OHSU |
ClinicalTrials.gov Identifier: | NCT00937365 History of Changes |
Other Study ID Numbers: |
5033 |
First Posted: | July 13, 2009 Key Record Dates |
Last Update Posted: | July 22, 2010 |
Last Verified: | July 2009 |
Keywords provided by Oregon Health and Science University:
Pregnancy Pain Low back pain Pubic symphysis pain CAM Complementary & Alternative Medicine Exercise Chiropractic Spinal manipulation Adjustments |
Neuroemotional technique Mind body Mind body therapy Attachment Maternal Fetal relationship Intrauterine attachment Heart rate variability VAS Visual analog scale Roland Morris Disability Index |
Additional relevant MeSH terms:
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |