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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise
Spinal Manipulation
Neuroemotional Technique (NET)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring 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

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Exercise

Spinal Manipulation

Neuroemotional technique (NET)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Roland Morris Disability Index

Secondary Outcome Measures

Pain Visual Analog Scale

Full Information

First Posted
July 10, 2009
Last Updated
December 16, 2019
Sponsor
Oregon Health and Science University
Collaborators
The ONE Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00937365
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
The ONE Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Spinal Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Neuroemotional technique (NET)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
pelvic tilts, stretch, strengthen, glut squeeze
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Manipulation
Other Intervention Name(s)
SMT, CMT, chiropractic manipulative therapy, OMT, osteopathic manipulative therapy, adjustment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Neuroemotional Technique (NET)
Other Intervention Name(s)
NET, Mind-body therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roland Morris Disability Index
Time Frame
Last study visit prior to birth
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale
Time Frame
Last Study Visit Before Birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Gregory, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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