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TerminatedNCT02269345AAstentUpdated Jul 28, 2020

Auricular Acupuncture in Ureteral Stent Pain

An interventional study of Battlefield Acupuncture and Standard Treatment in Pain, sponsored by Mike O'Callaghan Military Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Mike O'Callaghan Military Hospital · Not applicable, Interventional, and Other

Why this study was terminated
Unworkable. This study had several PIs and attempted several avenues of recruitment. Still were only able to recruit 34 out of the 120 needed.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators propose to complete a randomized controlled trial to compare battlefield auricular acupuncture at five points in right ear and five points in left ear (cingulate gyrus, thalamus, omega 2, point zero, and shen men) plus standard of care, versus standard of care alone, for symptomatic treatment of stent pain in postoperative ureteral stent patients. Male and female DoD beneficiaries ages 18 years or older, who are scheduled for elective urologic surgery that would be expected to have the routine placement of a ureteral stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, ESWL of stone greater than 10mm) will be recruited. Subjects will be followed up at 24 hours post surgery, 48 hours, 1 week, 1 month, and 1 month post surgery. The investigators will ask subjects to rate their pain level on a 0-10 analogue scale, the investigators will assess via the Ureteric Stent Symptoms Questionnaire (USSQ) subjects' urinary urgency, urinary frequency, and quality of life. The investigators will ask subjects how many pills they have taken for their pain including the quantity and dose to assess a reduction in pain medication use.

Read the detailed description

Subjects will be ages 18 years or older and scheduled for routine urologic surgery. To randomize subjects, the investigators will employ a random number generator, which will minimize difference between study groups.

Screening Visit:

Obtain signed Informed Consent document and HIPAA Authorization. Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, prior surgical history, demographics, problems list, and note any prior acupuncture received.

Subjects will be given a Medication Log to assist them in documenting the amount of pain medications that they are taking as part of standard of care.

Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).

Visit 1 (Baseline):

Subjects will be randomized into 1 of 2 groups:

Group 1: Standard operative and standard post-operative care plus BFA (up to 5 acupuncture needles* in each ear at points cingulate gyrus, thalamus, omega 2, shen-men, point zero, identified by point-finder) Group 2: Standard treatment alone. Subjects will be given treatment according to their randomization group. The investigators review the subject's medical record and document any standard of care pain assessments that were performed upon admission and after pain intervention to the Post Anesthesia Care Unit (PACU) and Same Day Surgery Unit (SDSU). The investigators will also record the amounts of standard of care pain medications used during their hospital stay.

All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after Visit 1.

Ear Acupuncture needles will fall out on their own within about one week.

Visit #2 (24 hours post-surgery):

Subject will be contacted in-person, via phone, email, or text message asked:

On a scale of 0-10, with 10 being the worst pain, what is their pain level? Have they returned to work or resumed normal household duties? If so, how many hours post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? Essentris electronic inpatient medical record will be reviewed to determine total dose of pain medications received if still in hospital.

Is the patient voiding without irritative symptoms? Urinary frequency, urgency, dysuria, hematuria will be assessed.

Visit #3 (48 hours post- surgery)

Subject will be contacted either in-person, or via phone, email or text message and asked:

On a scale of 0-10, with 10 being the worst pain, what is their level of pain? Have they returned to work or resumed normal household duties? If so, how many hours post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? Essentris electronic inpatient medical record will be reviewed to determine total dose of pain medications received if still in hospital.

Is the patient voiding without irritative symptoms? Urinary frequency, urgency, dysuria, hematuria will be assessed.

Visit #4 (1 week post-surgery)

Subject will be contacted either in-person, or via phone, email or text message and asked:

Have they returned to work or resumed normal household duties? If so, how many days post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? USSQ (Stent in Situ) will be administered to patients.

Visit #5 Visit (1 month post surgery with stent in-situ or 5 weeks post stent removal at week 1)

Subject will be contacted either in-person, or via phone, email or text message and asked:

Have they returned to work or resumed normal household duties? If so, how many days post-surgery? What pain medication are they taking? And what strength? How many total doses have they taken since their surgery? USSQ (Post Stent) will be administered to patients.

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Mike O'Callaghan Military Hospital is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion criteria

Inclusion:

  • Male and female DoD beneficiaries
  • Age 18 years or older who are scheduled for elective urologic surgery that would be expected to have the routine placement of a ureteral stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, extracorporeal stone wave lithotripsy (ESWL) of stone greater than 10mm).

Exclusion criteria

Exclusion:

  • Pregnant or breastfeeding.
  • Traumatic ureteral injury repairs with stents.
  • Ureteral stents placed during procedures for urologic cancer treatments.
  • Sepsis prior to stent placement or other active urologic infection.
  • Absence of ear.
  • Active cellulitis of ear.
  • Ear anatomy precluding identification of acupuncture landmarks.
  • Non-English speaking.
  • Use of Hearing Aids that preclude the insertion of ASP needles.
  • Inability to comply with study protocol.
  • Patients receiving treatment for chronic pain conditions.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Battlefield Acupuncture

    BFA at points cingulate gyrus, thalamus, omega 2, shen-men, point zero

    Other: Battlefield Acupuncture

  • Placebo comparator
    Standard Treatment

    Standard Treatment alone

    Other: Standard Treatment

Interventions

  • OtherBattlefield Acupuncture

    Battlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero

  • OtherStandard Treatment

    Standard Treatment alone.

06

What researchers measure

Primary outcomes

  1. improved ability to tolerate the presence of the ureteral stent

    This will be assessed via the Ureteric Stent Symptoms Questionnaire

    Time frame: 1 month

Secondary outcomes

  1. reduce narcotic use

    We will ask the participant during each visit what pain medication are they taking? And what strength? How many total doses have they taken since their surgery?

    Time frame: 1 month

  2. post-operative readmission rates for pain/irritative symptoms

    Time frame: 1 month

07

Study locations

1 site
  • Mike O'Callaghan Federal Medical Center
    Nellis Air Force Base, Nevada 89191, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02269345
Lead sponsor
Mike O'Callaghan Military Hospital
Responsible party
Sponsor
First posted
Oct 21, 2014
Start date
Feb 2015
Primary completion
May 12, 2020
Completion
May 12, 2020
Last update
Jul 28, 2020

Study contacts

Paul Crawford, MD
principal investigator · Mike O'Callaghan Federal Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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