Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Pregnancy Related Low Back Pain Clinical Trial

Official title:

Acupuncture and Low Back Pain During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571480
• Other study ID #: HIC 12291
• Secondary ID: 5R21AT001613-03
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: July 17, 2009
• Start date: February 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 46 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pregnancy Related Low Back Pain

Intervention

Other:
• acupuncture
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
• Sham acupuncture
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
• standard of care
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity pain		two weeks	Yes
Secondary	daily disability index		2 weeks	Yes