Acupuncture for Pain Management During Uterine Aspiration
Condition: Pain Acute; Acupuncture
MeSH terms: Acute Pain
Study type: Interventional

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.
    

Intervention name(s): SEIRIN® Pyonex™ Acupuncture Needles; 12 mm Plasters
Intervention type(s): Device; Procedure
Intervention description(s): 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; 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
Other intervention name(s): Needle, Acupuncture, Single Use; hypoallergenic, adhesive replacement plasters
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either 1 - auricular acupuncture with pyonex needle, 2 - placebo adhesive, or 3 - routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 6 or 9.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care