Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04040140 |
| Other study ID # |
IRB00183805 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 8, 2019 |
| Est. completion date |
January 30, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aims of this proposal are to (1) examine the feasibility of providing a training course
of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into
real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related
pain (CRP) under the usual conditions.
Description:
Cancer-related pain (CRP) is considered one of the most challenging symptoms that cancer
patients experience. Opioid use is the most common strategy to manage pain. However,
pharmacological treatments are associated with a variety of adverse side effects, including
drowsiness, constipation, dry mouth, and the potential for addiction. As a result, up to 52%
of cancer patients do not receive adequate analgesic medication. The high prevalence of pain
and ineffective CRP management highlight the limitations of current CRP strategies. An
effective, nonpharmacological patient-managed strategy-that has potential to provide quick
and low-cost pain relief without new side effects-is an essential next step to manage CRP.
Auricular point acupressure (APA), a non-invasive and nonpharmacological patient-managed
strategy, can be an innovative solution for CRP. APA is derived from Chinese Medicine and is
different from auricular acupuncture, which is an invasive (using needles) and passive
treatment (administered by a licensed practitioner). APA is a non-invasive and active
treatment for patients with pain and other symptoms. It involves needleless, acupuncture-like
stimulation of ear points. Small seeds are taped on specific ear points for stimulation by
patients. Once the seeds have been taped on the patient's ear by the skilled provider, the
patient is able to co-manage patient's treatment at home. APA is popular in Taiwan, China,
and Europe. Though its use is limited in the U.S., a limited number of clinical trials have
supported APA. To achieve pain relief, the participant presses on the seeds to stimulate ear
points three times daily, three minutes per time, for a total of nine minutes per day. APA
provides pain relief within 1-2 minutes after ear stimulation and also sustains pain relief
for one month after a 4-week APA intervention. The rapid pain relief makes APA an attractive
strategy to manage CRP.
The investigators' team has conducted a series of APA studies among patients with (1) chronic
low back pain, (2) aromatase inhibitor musculoskeletal symptoms (AIMSS), (3) persistent
post-mastectomy pain, and (4) chemotherapy-induced neuropathy (CIN). All of the
investigators' pilot studies demonstrated better than a clinically significant pain reduction
(30% reduction) after 4 weeks of APA and sustained effects for 1-month. Significant plasma
inflammatory changes (IL-1β, IL-2, IL-6, Tumor Necrosis Factor α, and IFNγ) were found after
4 weeks, indicating that APA may affect brain macrophage-cells resulting in inflammatory
cytokines alterations, leading to sustained pain relief at 1-month follow-up. Based on these
findings, the investigators believe APA would be particularly suitable to reduce CRP. More
importantly, easy implementation of APA and its immediate and lasting pain relief can empower
and motivate cancer patients to adhere to APA treatment and allows patients to engage other
forms of pain intervention, such as maintaining and/or increasing physical activity as a
by-product of improved analgesia.
Nurses are the patient's first line of support in managing CRP; however, nurses have limited
tools available to accomplish this. The most common treatments that nurses have at nurses'
disposal are the usage of analgesics or referrals to specialty consultations. Once patients
are referred, the role of nurses as cohesive guides and caretakers is often lost. To address
this dilemma, patients and nurses need access to a therapy that can quickly relieve the pain,
which, in turn, reduces the analgesic use and encourages patients and nurses to engage in
other pain interventions. Due to the non-invasive characteristic of APA, nurses can learn APA
and incorporate it into nurses' practice to provide pain relief and augment the effects of
other pain interventions.
The aims of this proposal are to (1) examine the feasibility of providing a training course
of APA for clinical oncology nurses which can integrate APA into real-world nursing care
settings and (2) examine the effectiveness of APA on CRP under the usual conditions.
