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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AT001613-03 | U.S. NIH Grant/Contract | View source |
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Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 true acupuncture | Experimental | acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain |
|
| 2 | Sham Comparator | three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy |
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| 3 | Other | standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| severity pain | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| daily disability index | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-Ming Wang, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06620 | United States |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
| Sham acupuncture | Other | ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain |
|
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| standard of care | Other | participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress |
|
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |