Auricular Acupuncture in Ureteral Stent Pain

NCT02269345 | Terminated

• 1 other identifier: FWH20140088H
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• improved ability to tolerate the presence of the ureteral stent

  This will be assessed via the Ureteric Stent Symptoms Questionnaire

  1 month

Secondary Outcomes (2)

• reduce narcotic use

  1 month

• post-operative readmission rates for pain/irritative symptoms

  1 month

Study Arms (2)

Battlefield Acupuncture

EXPERIMENTAL

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

Other: Battlefield Acupuncture

Standard Treatment

PLACEBO COMPARATOR

Standard Treatment alone

Other: Standard Treatment

Interventions

Battlefield Acupuncture OTHER

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

Battlefield Acupuncture

Standard Treatment OTHER

Standard Treatment alone.

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Crawford, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2015
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)