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Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Primary Purpose

Pregnancy Related Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sham acupuncture
standard of care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related Low Back Pain focused on measuring auricular acupuncture, pregnancy related low back pain, acupuncture

Eligibility Criteria

13 Years - 46 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
  • No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.

Exclusion Criteria:

  • Non-English speaking
  • Mentally challenged
  • State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
  • Pregnant women without low back pain
  • The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

1 true acupuncture

2

3

Arm Description

acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain

three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy

standard of care

Outcomes

Primary Outcome Measures

severity pain

Secondary Outcome Measures

daily disability index

Full Information

First Posted
December 10, 2007
Last Updated
July 17, 2009
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00571480
Brief Title
Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy
Official Title
Acupuncture and Low Back Pain During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
Detailed Description
Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 & 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related Low Back Pain
Keywords
auricular acupuncture, pregnancy related low back pain, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 true acupuncture
Arm Type
Experimental
Arm Description
acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain
Arm Title
2
Arm Type
Sham Comparator
Arm Description
three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
Arm Title
3
Arm Type
Other
Arm Description
standard of care
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
retained ear acupuncture treatment
Intervention Description
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Other Intervention Name(s)
retained ear acupuncture treatment
Intervention Description
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
Intervention Type
Other
Intervention Name(s)
standard of care
Intervention Description
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
Primary Outcome Measure Information:
Title
severity pain
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
daily disability index
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy. No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention. Exclusion Criteria: Non-English speaking Mentally challenged State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain Pregnant women without low back pain The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Ming Wang, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06620
Country
United States

12. IPD Sharing Statement

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