NCT00571480

Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Acupuncture and Low Back Pain During Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 13 Years – 46 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-12-12
• Last updated: 2009-07-21

Locations

1 site across 1 country: United States