Acupuncture for Pain Management During Uterine Aspiration

August 29, 2019 updated by: Carolyn Westhoff, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • hypoallergenic, adhesive replacement plasters
No Intervention: Routine Care
This arm will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the completion of the procedure (approximately 10 minutes later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later)
Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care
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.
at the completion of the procedure (approximately 5-10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Carolyn Westhoff, MD MSc, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR2610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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