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Acupuncture for Pain Management During Uterine Aspiration

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ClinicalTrials.gov Identifier: NCT03391986
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Pain Acute Acupuncture Device: SEIRIN® Pyonex™ Acupuncture Needles Procedure: 12 mm Plasters

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
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)
Masking Description:

Participant: only participants in the pyonex needle and placebo adhesive group will be masked during the study. Equipment is opened behind the participant and the needles and adhesives are placed outside the view of the participant.

Care Provider: A colored hat that covers the participants ears will be placed. Outcomes Assessor: Group assignment will be masked.

Primary Purpose: Supportive Care
Official Title: Auricular Acupuncture as Adjunct for Pain Management During First Trimester Uterine Aspiration.
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pyonex needles
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.
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
Other Name: Needle, Acupuncture, Single Use
Placebo Comparator: Placebo adhesives
This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.
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
Other Name: hypoallergenic, adhesive replacement plasters
No Intervention: Routine Care
This arm will receive no intervention.


Outcome Measures

Primary Outcome Measures :
  1. Visual Analog Scale for Pain (VAS Pain) score - Acupuncture versus Routine Care [ Time Frame: at the completion of the procedure (approximately 10 minutes later) ]
    Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales.


Secondary Outcome Measures :
  1. Change in Visual Analog Scale for Pain (VAS Pain) score - Placebo versus Routine Care [ Time Frame: prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later) ]
    Measure effectiveness of placebo as an adjunct to ibuprofen and paracervical block for pain control during uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive placebo adhesives and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life).

  2. Patient satisfaction survey score [ Time Frame: at the completion of the procedure (approximately 5-10 minutes) ]
    Using a satisfaction survey (investigator-developed, 6 questions, each question is graded on a scale of 1-5, 1 being very poor and 5 being very good) to measure effectiveness of auricular acupuncture for improving satisfaction.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English- or Spanish-speaking women
  • Age 18 or older
  • Seeking first trimester suction aspiration for undesired pregnancy, early pregnancy failure, retained products of conception, or molar pregnancy
  • Intrauterine pregnancy with gestational age less than or equal to 12 weeks and 6 days
  • Willingness to receive acupuncture and be randomized in the study

Exclusion Criteria:

  • Allergy to adhesives
  • Allergy to or cannot receive ibuprofen or 1% lidocaine
  • Congenital anomalies of the ear including anotia and microtia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391986


Contacts
Contact: Chioma Ndubisi, MD 212-305-4938 cn2422@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Chioma Ndubisi, MD    212-305-4938    cn2422@cumc.columbia.edu   
Principal Investigator: Carolyn Westhoff, MD, MSc         
Sponsors and Collaborators
Columbia University
Society of Family Planning
Investigators
Principal Investigator: Carolyn Westhoff, MD MSc Columbia University
More Information

Additional Information:
Publications:
Oleson, T (1998). "Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture, 2nd edition." California, Health Care Alternatives, Inc
White K, Jones H, Lichtenberg S, Paul M (2015). "First trimester surgical abortion practices in the United States." Poster presented at: Society of Family Planning Forum in 2015.

Responsible Party: Carolyn L. Westhoff, Professor of Epidemiology and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT03391986     History of Changes
Other Study ID Numbers: AAAR2610
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No