PainAAstentNCT02269345
Auricular Acupuncture in Ureteral Stent Pain
A study testing Battlefield Acupuncture and Standard Treatment in people with Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Battlefield Acupuncture and Standard Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: 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.
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.
- Conditions
- Pain
- Being tested
- Battlefield Acupuncture, Standard Treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield AcupunctureOther
Battlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero
Standard TreatmentOther
Standard Treatment alone.
| Study group | Role | What they receive |
|---|---|---|
| Battlefield Acupuncture | Experimental | BFA at points cingulate gyrus, thalamus, omega 2, shen-men, point zero Receives: Other: Battlefield Acupuncture |
| Standard Treatment | Placebo comparator | Standard Treatment alone Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved ability to tolerate the presence of the ureteral stent
This will be assessed via the Ureteric Stent Symptoms Questionnaire
Measured: 1 month
Secondary outcomes (2)
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?
Measured: 1 month
post-operative readmission rates for pain/irritative symptoms
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion12 May 2020
- Study completion12 May 2020
Why it stopped: Unworkable. This study had several PIs and attempted several avenues of recruitment. Still were only able to recruit 34 out of the 120 needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269345
- Sponsor's protocol ID
- FWH20140088H
- Acronym
- AAstent
- Status last verified
- Jul 2020
- First submitted
- 14 Oct 2014
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture: A Novel Application in Ureteral Stent Pain.
- ClinicalTrials.gov ID
- NCT02269345
- Acronym / sponsor ID
- AAstent / FWH20140088H
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unworkable. This study had several PIs and attempted several avenues of recruitment. Still were only able to recruit 34 out of the 120 needed.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Feb 2015 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Battlefield Acupuncture | Experimental | Other: Battlefield AcupunctureBFA at points cingulate gyrus, thalamus, omega 2, shen-men, point zero |
| Standard Treatment | Placebo comparator | Other: Standard TreatmentStandard Treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battlefield AcupunctureBattlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero | Other | Battlefield Acupuncture |
| Standard TreatmentStandard Treatment alone. | Other | Standard Treatment |
Primary outcome
improved ability to tolerate the presence of the ureteral stent
Time frame: 1 month
This will be assessed via the Ureteric Stent Symptoms Questionnaire
2 secondary outcomes
reduce narcotic use
Time frame: 1 month
post-operative readmission rates for pain/irritative symptoms
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Unworkable. This study had several PIs and attempted several avenues of recruitment. Still were only able to recruit 34 out of the 120 needed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield Acupuncture and Standard Treatment in people with Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unworkable. This study had several PIs and attempted several avenues of recruitment. Still were only able to recruit 34 out of the 120 needed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved ability to tolerate the presence of the ureteral stent (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.