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

NCT00937365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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.

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.

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.

Sponsors & Collaborators

  • The ONE Foundation

    collaborator UNKNOWN

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Thomas Gregory, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937365 on ClinicalTrials.gov