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
  Purpose

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


Condition Intervention
Pregnancy Related Low Back Pain
Other: acupuncture
Other: Sham acupuncture
Other: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture and Low Back Pain During Pregnancy

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • severity pain [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • daily disability index [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 159
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 true acupuncture
acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for 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
Sham Comparator: 2
three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy
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
3
standard of care
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571480

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06620
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Shu-Ming Wang, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Shu-Ming Wang, M.D., Yale University
ClinicalTrials.gov Identifier: NCT00571480     History of Changes
Other Study ID Numbers: HIC 12291, 5 R21 AT001613-03
Study First Received: December 10, 2007
Last Updated: July 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
auricular acupuncture
pregnancy related low back pain
acupuncture

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014