Low Back Pain
Conditions
Keywords
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
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise
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.
PROCEDURESpinal 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.
PROCEDURENeuroemotional 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.
Sponsors
The ONE Foundation
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Roland Morris Disability Index | Last study visit prior to birth |
Secondary
| Measure | Time frame |
|---|---|
| Pain Visual Analog Scale | Last Study Visit Before Birth |
Countries
United States
Outcome results
None listed