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Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00571480
First received: December 10, 2007
Last updated: July 17, 2009
Last verified: July 2009

December 10, 2007
July 17, 2009
February 2005
January 2008   (final data collection date for primary outcome measure)
severity pain [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00571480 on ClinicalTrials.gov Archive Site
daily disability index [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy
Acupuncture and Low Back Pain During Pregnancy

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Pregnancy Related Low Back Pain
  • Other: acupuncture
    ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
    Other Name: retained ear acupuncture treatment
  • Other: Sham acupuncture
    ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
    Other Name: retained ear acupuncture treatment
  • Other: standard of care
    participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
    Other Name: standard of care
  • Experimental: 1 true acupuncture
    acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain
    Intervention: Other: acupuncture
  • Sham Comparator: 2
    three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
    Intervention: Other: Sham acupuncture
  • 3
    standard of care
    Intervention: Other: standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Female
13 Years to 46 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571480
HIC 12291, 5 R21 AT001613-03
No
Shu-Ming Wang, M.D., Yale University
Yale University
Not Provided
Principal Investigator: Shu-Ming Wang, MD Yale School of Medicine
Yale University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP