Auricular Acupuncture in Ureteral Stent Pain

NCT ID: NCT02269345

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2020-05-12

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Battlefield Acupuncture

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

Group Type: EXPERIMENTAL

Battlefield Acupuncture

Intervention Type: OTHER

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

Standard Treatment

Standard Treatment alone

Group Type: PLACEBO_COMPARATOR

Standard Treatment

Intervention Type: OTHER

Standard Treatment alone.

Interventions

Battlefield Acupuncture

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

Intervention Type: OTHER

Standard Treatment

Standard Treatment alone.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Medical Center

Locations

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Countries

United States

Other Identifiers

FWH20140088H

Identifier Type: -

Identifier Source: org_study_id