Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related Low Back Pain
• Interventions: Other: acupuncture; Other: Sham acupuncture; Other: standard of care

• Registration Number: NCT00571480
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 true acupuncture	acupuncture	acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain
2	Sham acupuncture	three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
3	standard of care	standard of care

Primary Outcome Measures

Name	Time	Method
severity pain	two weeks

Secondary Outcome Measures

Name	Time	Method
daily disability index	2 weeks

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States