Expired Study
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New Haven, Connecticut 06620


Purpose:

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


Study summary:

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.


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.


NCT ID:

NCT00571480


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06620
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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