Clinical trial NCT00937365: Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment
Official title: A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
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
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: The ONE Foundation
First posted: 2009-07-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Roland Morris Disability Index
timeFrame: Last study visit prior to birth
Secondary outcomes:
measure: Pain Visual Analog Scale
timeFrame: Last Study Visit Before Birth
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Thomas Gregory, MD
role: PRINCIPAL_INVESTIGATOR
References:
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