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NCT Number: NCT00937365

Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment

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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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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: pelvic tilts, stretch, strengthen, glut squeeze

Spinal manipulation

Procedure

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: SMT, CMT, chiropractic manipulative therapy, OMT, osteopathic manipulative therapy, adjustment

Neuroemotional Technique (NET)

Procedure

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: NET, Mind-body therapy

Primary outcomes

  1. Roland Morris Disability Index

    Time frame: Last study visit prior to birth

Secondary outcomes

  1. Pain Visual Analog Scale

    Time frame: Last Study Visit Before Birth

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • The ONE Foundation

Registry information

Official study title

A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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