Pregnancy Related Low Back Pain
Conditions
Keywords
auricular acupuncture, pregnancy related low back pain, acupuncture
Brief summary
Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
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.
Interventions
OTHERacupuncture
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
OTHERSham acupuncture
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
OTHERstandard of care
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 46 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| severity pain | two weeks |
Secondary
| Measure | Time frame |
|---|---|
| daily disability index | 2 weeks |
Countries
United States
Outcome results
None listed