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Trial record 3 of 20 for:    Stents | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Auricular Acupuncture in Ureteral Stent Pain (AAstent)

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ClinicalTrials.gov Identifier: NCT02269345
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
JillClark, Mike O'Callaghan Military Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Other: Battlefield Acupuncture Other: Standard Treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Auricular Acupuncture: A Novel Application in Ureteral Stent Pain.
Actual Study Start Date : February 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Battlefield Acupuncture
BFA at points cingulate gyrus, thalamus, omega 2, shen-men, point zero
Other: Battlefield Acupuncture
Battlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero

Placebo Comparator: Standard Treatment
Standard Treatment alone
Other: Standard Treatment
Standard Treatment alone.




Primary Outcome Measures :
  1. improved ability to tolerate the presence of the ureteral stent [ Time Frame: 1 month ]
    This will be assessed via the Ureteric Stent Symptoms Questionnaire


Secondary Outcome Measures :
  1. reduce narcotic use [ Time Frame: 1 month ]
    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?

  2. post-operative readmission rates for pain/irritative symptoms [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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:

  • 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.

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): NCT02269345


Contacts
Contact: Jill M Clark, MBA/HCM 702-653-3298 jill.m.clark15.ctr@mail.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Principal Investigator: Paul Crawford, MD         
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
Principal Investigator: Paul Crawford, MD Mike O'Callaghan Federal Medical Center

Responsible Party: JillClark, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02269345     History of Changes
Other Study ID Numbers: FWH20140088H
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No