Auricular Acupuncture in Ureteral Stent Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2018 |
| Start Date: | February 2015 |
| End Date: | February 2020 |
| Contact: | Jill M Clark, MBA/HCM |
| Email: | jill.m.clark15.ctr@mail.mil |
| Phone: | 702-653-3298 |
Auricular Acupuncture: A Novel Application in Ureteral Stent Pain.
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.
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.
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.
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.
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.
We found this trial at
1
site
4700 North Las Vegas Boulevard
Nellis Air Force Base, Nevada 89191
Nellis Air Force Base, Nevada 89191
Principal Investigator: Paul Crawford, MD
Phone: 702-653-3298
Click here to add this to my saved trials
