Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01447329 |
| Other study ID # |
FWH20110169H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2011 |
| Est. completion date |
January 2014 |
Study information
| Verified date |
January 2024 |
| Source |
Mike O'Callaghan Military Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators propose to complete a randomized controlled trial to compare ear
acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and
left ear plus standard of care versus standard of care alone for symptomatic treatment of
pain following ambulatory arthroscopic knee surgery. After the subject has been discharged,
phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month.
These contacts will be used to assess the subject's pain level, ambulation status, doses of
analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be
asked the PIQ-6 Pain Impact Questionnaire.
Description:
Subjects (DoD beneficiaries) that are 18 years or older with a scheduled ambulatory
arthroscopic knee surgery will present for their pre-op appointment. At the time of check-in
the subjects meeting the inclusion criteria, will be offered the opportunity to participate.
Informed Consent and HIPAA Authorization will be obtained prior to any study-related
procedures or any sedation being performed. The subject will be asked the screening questions
for exclusion criteria (See attached instrument). The PI will have the AI or Study staffs
recruit their patients to prevent any misconception of coercion. The subjects Armed Forces
Health Longitudinal Technology Application (AHLTA) record including previous encounters,
vital signs review, medication list, demographics and problems list will be reviewed by one
of the investigators to confirm the inclusion/exclusion criteria have been met. The
investigator will evaluate the subject and determine any further exclusion criteria based on
exam. These subjects will then be randomized into two groups using a random number generator
via block randomization by the Research Coordinator:
Group 1: Standard treatment alone Group 2: Standard treatment plus ear acupuncture
Subjects will be asked upon admittance to the PACU and the SDSU to answer the questions in
the Data Collection Tool. Subjects will be given treatment while in the operating room and
while under sedation according to their randomization group. The right and left ears will be
cleansed with an alcohol swab prior to ear acupuncture. All subjects, regardless of study
group, will get band aid to cover both ears. This is done to blind the orthopedic surgeon,
the anesthesiologist and any nursing staff that comes in contact with the patient. Even
though they are getting standard of care pain treatment, the investigators are blinding these
individuals to remove any potential of bias when they are assessing a subject's pain.
Subjects in both groups will be instructed to remove the band aids 24 hours after their
surgery. After the subject has been discharged, phone calls, emails or text messages will be
made at 24 and 48 hours, 1 week and 1 month. These contacts will be used to assess the
subject's pain level, ambulation status, doses of analgesics taken and time to return to full
duty. At 1 week and 1 month, subjects will be asked the PIQ-6 Pain Impact Questionnaire.
Subjects are getting the knee arthroscopy as part of standard of care in this study. It is
standard of care to have military members return to to light-duty 2 weeks after knee
arthroscopy and full-duty 6 weeks after knee arthroscopy. Should the subject return to duty
with the acupuncture needles still in place, this will not affect their ability to perform
their duties, however, to maintain compliance with AFI 36-2903, you may want to remove the
needles or place a bandage over both ears to cover the ear acupuncture needles.
Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear
include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points
on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject
will receive five needles intra-operatively on each ear.
Subject's participation in this study is completed after 1 month.
Patients in group 2 who are receiving ear Acupuncture will be instructed to have no heavy
meals, excessive hot or cold foods, heavy exercise or intercourse and no alcohol for 24
hours. Ear Acupuncture needles will fall out on their own within about 6 days.
All investigators are trained in Battlefield Acupuncture and credentialed by the MOFH
Credentials committee to perform Battlefield Acupuncture.
The investigators anticipate that the ear acupuncture will reduce the doses of analgesics
needed to control pain, decrease time to discharge, reduce time to ambulation without
assistance and improve return to duty time.
The standing orders for post-operative care pain control are attached. The risks associated
with the use of ear acupuncture needles include: pain, bleeding, infection (very rare) and
flare of signs and symptoms. In the event the acupuncture needles do not fall out within 6
days, patients will be instructed to come in and have them removed by one of the
Investigators. In this study the investigators are using Sedatelec ASP Original Gold needles.
These acupuncture needles are sterile, gold plated semi permanent ear acupuncture needles for
single use.
If at any time during the study, the subject decides to withdraw from the study, they can
come in and have the ear acupuncture needles removed by one of the Investigators. If patients
are withdrawn from the study, they will have the option to either have the acupuncture
needles removed by one of the investigators or allow them to fall out on their own.
Patients must agree to take precautions to prevent pregnancy during the initial phase
(surgery) of this study. Pregnancy tests are routinely done as standard of care for all women
prior to surgery. The only completely reliable methods of birth control are total abstinence
or surgical removal of the uterus. Other methods, such as the use of condoms, a diaphragm or
cervical cap, birth control pills, IUD, or sperm killing products are not totally effective
in preventing pregnancy. Also, women who are breastfeeding at the time of surgery may not
participate in this study.
