Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

NCT ID: NCT00571480

Last Updated: 2009-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-01-31

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.

Conditions

Pregnancy Related Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 true acupuncture

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

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

2

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

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain

3

standard of care

Group Type: OTHER

standard of care

Intervention Type: OTHER

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

Interventions

acupuncture

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

Intervention Type: OTHER

Sham acupuncture

ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain

Intervention Type: OTHER

standard of care

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

Intervention Type: OTHER

Other Intervention Names

retained ear acupuncture treatment; retained ear acupuncture treatment

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Yale University

Principal Investigators

Shu-Ming Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

5R21AT001613-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HIC 12291

Identifier Type: -

Identifier Source: org_study_id