Auricular Point Acupressure: Examining the Scientific Underpinnings of Pain Relief



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:February 15, 2018
End Date:January 30, 2019

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Chemotherapy-induced peripheral neuropathy (CIPN)—numbness, burning and stunning pain
distributed in hands and feet—is a major challenge among cancer patients. Even after
completion of chemotherapy, CIPN persists among ~30-40% of cancer patients, which can
negatively impact quality of life. The only drug (duloxetine) better than placebo in a
randomized control trial improved pain intensity by 0.72 points on a scale of 0-10, which
cannot manage CIPN effectively. A better pain management strategy clearly needs to be
developed.

The investigators propose to test auricular point acupressure (APA), a non-invasive, easily
administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe,
and effective pain relief so that cancer patients can self-manage their CIPN. APA involves an
acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to
specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and
index finger, three times a day (morning, noon, and evening) for three minutes each session
to achieve pain relief. The investigators have developed a detailed APA protocol to teach
health-care providers without experience in acupuncture and traditional Chinese Medicine that
investigators can learn about APA in brief educational seminars as a treatment including the
systematic identification of ear points (called auricular diagnosis). The investigators teach
methods that enable patients to continue using APA to self-manage their pain. However APA is
not available in current U.S. health care setting yet.

Quantitative sensory testing (QST) and fMRI in acupuncture have provided new objective
methods for measuring pain. QST provides an evaluation of peripheral and central mechanisms
of pain by quantifying stimulus-evoked negative and positive sensory phenomena to evaluate a
participant's perception of threshold values regarding pain generated through touch (A beta
fibers), warmth (C fibers), cold (A delta fibers), and heat (C fibers). Studies have
demonstrated changes in heat, pressure, and mechanical pain thresholds immediately following
acupuncture; however no study in APA yet. Brain imaging studies in acupuncture indicate that
acupuncture can restore normal functional connectivity related to pain reduction. In
conjunction with the investigators pilot data demonstrating that APA impacts neural-immune
signaling in patients with chronic low back pain, the investigators hypothesize that APA may
likewise induce pain relief through the stimulation of A beta fibers and/or C fibers to
increase the pain threshold, endogenous opioid binding (releasing inflammatory cytokines),
and alter brain networks of central processing in the hypothalamic-pituitary-adrenocortical
axis to achieve analgesia.

The investigators plan to study the mechanisms underpinning pain sensitivity and pain
processing due to APA on CIPN. Along with the clinical and subjective CIPN outcomes,
objective outcomes will include physiological change in pain sensory thresholds (measured by
quantitative sensory testing), brain change associated with pain processing (measured by
fMRI), and neuro-transmitters (measured by inflammatory cytokines).


Inclusion Criteria:

- Cancer patients who are 18 years of age or olde

- Able to read and write English

- Have CIPN due to received neurotoxic chemotherapy for cancer

- Had average intensity of pain due to CIPN ≥ 4 on a 11-point numerical pain scale in
the previous week

- Pain > 3 months duration attributed to CIPN.

Exclusion Criteria:

- Use of an investigational agent for pain control concurrently or within the past 30
days;

- Use of an implantable drug delivery systems, e.g. Medtronic Synchromed

- Prior celiac plexus block, or other neurolytic pain control treatment

- Other identified causes of painful paresthesia existing prior to chemotherapy (e.g.,
radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing
peripheral neuropathy of another etiology

- Allergy to latex (the tapes for the APA include latex).
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