NCT03391986

Acupuncture for Pain Management During Uterine Aspiration

Auricular Acupuncture as Adjunct for Pain Management During First Trimester Uterine Aspiration.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The proposed study will be a randomized, double blinded, placebo-controlled trial to evaluate the efficacy of auricular acupuncture as adjunct for pain management during abortion. Women seeking first trimester uterine aspiration procedure who enroll in the study will be randomized to receive: 1) auricular acupuncture using pyonex needles, 2) placebo using an adhesive, 3) or routine care. Both participants and the treating physician will be unaware of treatment assignment. The primary outcome will compare the maximum pain score as measured by the visual analog scale (VAS) between the auricular acupuncture group and the routine care group. The secondary outcome will compare the maximum pain score between placebo group to the routine care group. The study will also investigate patient satisfaction.

Detailed description

Of the estimated 1.06 million abortions performed in the United States in 2011, approximately 91% occurred before 13 weeks gestation. Most first trimester abortions are performed in an outpatient center with a paracervical block as the only analgesic. Paracervical block is associated with improved pain control during dilation and aspiration however, women still experience moderate to severe pain. Moderate sedation and general anesthesia, minimize pain more than a paracervical block; however increased cost, regulatory constraints, side effects, health risks, and recovery time may limit abortion access. Pain experienced during abortion results from a complex interaction of physical innervation pathways, psychological and social factors. Pain during abortion is also influenced by additional factors such as age, pregnancy history, and self-reported pre-procedure anxiety about abortion. Adequate pain management during suction aspiration might require interventions that influence mental and emotional states as well as physical pain. Acupuncture affects perception of painful stimuli and improves anxiety. Peripheral stimulation of acupoints mobilizes central neuropeptides involved in the pathway of anxiety and stress. In auricular acupuncture, a technique of acupuncture, needles are placed in designated acupoints on the external ear in order to alleviate health conditions, in particular pain, in other parts of the body. In a pilot study completed at Columbia University Medical Center (CUMC) in 2016, patients seeking first trimester uterine aspiration were interested in the complementary medicine technique of auricular acupuncture as an adjunct to local anesthesia. Currently, the effectiveness of auricular acupuncture to control pain during a uterine suction aspiration is unknown. Participants will be randomized to either auricular acupuncture with pyonex needle adhesives, placebo adhesive, or routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 4 or 6. An investigator experienced with generating randomization sequences and not directly involved in the study will be responsible for creating the entire randomized schedule; first by defining the sequence of block sizes and second, by defining the assignments within each block. The division research office at CUMC will prepare opaque, sealed envelopes containing cards indicating whether a given patient has been randomized to receive either pyonex needles, placebo adhesive, or routine care. The allocation will remain concealed from the patient and abortion provider. The acupuncturist will open the sealed, opaque envelope immediately prior to the suction aspiration procedure and perform the intervention according to randomization assignment.

Conditions

• Pain Acute
• Acupuncture

Interventions

Type	Name	Description
DEVICE	SEIRIN® Pyonex™ Acupuncture Needles	Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
PROCEDURE	12 mm Plasters	12 mm (0.5"). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix

Timeline

• Start date: 2017-09-09
• Primary completion: 2018-04-30
• Completion: 2018-07-01
• First posted: 2018-01-05
• Last updated: 2019-09-03
• Results posted: 2019-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study