Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Study Overview
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Brief Summary
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Ear acupuncture can be used as a treatment for pregnancy induced low back pain.

Detailed Description
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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.

Official Title
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Acupuncture and Low Back Pain During Pregnancy

Conditions
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Pregnancy Related Low Back Pain

Intervention / Treatment
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* Other: acupuncture
* Other: Sham acupuncture
* Other: standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 true acupuncture<br>acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain | Other: acupuncture<br>* ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain<br>* Other names: retained ear acupuncture treatment;|
| Sham Comparator: 2<br>three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy | Other: Sham acupuncture<br>* ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain<br>* Other names: retained ear acupuncture treatment;|
| Other: 3<br>standard of care | Other: standard of care<br>* participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity pain |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily disability index |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auricular acupuncture, pregnancy related low back pain, acupuncture