Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

July 17, 2009 updated by: Yale University

Acupuncture and Low Back Pain During Pregnancy

Ear acupuncture can be used as a treatment for pregnancy induced low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06620
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 true acupuncture
acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain
Other: acupuncture
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
Other Names:
  • retained ear acupuncture treatment
Sham Comparator: 2
three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
Other: Sham acupuncture
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
Other Names:
  • retained ear acupuncture treatment
Other: 3
standard of care
Other: standard of care
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
severity pain
Time Frame: two weeks
two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
daily disability index
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Shu-Ming Wang, MD, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 21, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC 12291
  • 5R21AT001613-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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