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OpenTrials
Completed

NCT Number: NCT00571480

Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

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

Completed

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Key information

Age range

13 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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 Acupuncture

Other

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

Standard of care

Other

participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress

Primary outcomes

  1. severity pain

    Time frame: two weeks

Secondary outcomes

  1. daily disability index

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Acupuncture and Low Back Pain During Pregnancy

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2007
Registry last updated
Jul 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.