Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Yale University

Status: Completed

Conditions: Pregnancy Related Low Back Pain

Treatments: Other: standard of care; Other: Sham acupuncture; Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00571480

5R21AT001613-03 (U.S. NIH Grant/Contract)

HIC 12291

Details and patient eligibility

About

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

Full 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.

Enrollment: 159 patients

Sex: Female

Ages: 13 to 46 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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159 participants in 3 patient groups

1 true acupuncture

Experimental group

Description:

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

Treatment:

Other: acupuncture

2

Sham Comparator group

Description:

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

Treatment:

Other: Sham acupuncture

3

Other group

Description:

standard of care

Treatment:

Other: standard of care