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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The ONE Foundation
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00937365
First received: July 10, 2009
Last updated: July 21, 2010
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Behavioral: Exercise
Procedure: Spinal Manipulation
Procedure: Neuroemotional Technique (NET)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Roland Morris Disability Index [ Time Frame: Last study visit prior to birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Visual Analog Scale [ Time Frame: Last Study Visit Before Birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:
  • pelvic tilts
  • stretch
  • strengthen
  • glut squeeze
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.
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:
  • SMT
  • CMT
  • chiropractic manipulative therapy
  • OMT
  • osteopathic manipulative therapy
  • adjustment
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.
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:
  • NET
  • Mind-body therapy

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

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937365

Contacts
Contact: Caroline D Peterson, DC, PhD 503-367-1172 petcarol@ohsu.edu
Contact: Thomas Gregory, MD 503-494-3107 gregoryt@ohsu.edu

Locations
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         
Sponsors and Collaborators
Oregon Health and Science University
The ONE Foundation
Investigators
Principal Investigator: Thomas Gregory, MD Oregon Health and Science University
  More Information

Publications:

Responsible Party: Caroline Peterson, DC, PhD, MPH, CPM, OHSU
ClinicalTrials.gov Identifier: NCT00937365     History of Changes
Other Study ID Numbers: 5033
Study First Received: July 10, 2009
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Complementary & Alternative Medicine
Pregnancy
Pain
Low back pain
Pubic symphysis pain
CAM
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:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014