Auricular Point Acupressure to Manage Pain in Patients With Alzheimer's Disease and Related Disorders



Status:Recruiting
Conditions:Alzheimer Disease, Chronic Pain
Therapuetic Areas:Musculoskeletal, Neurology
Healthy:No
Age Range:21 - 85
Updated:10/18/2018
Start Date:August 1, 2018
End Date:December 30, 2019
Contact:Chao Hsing Yeh, PhD
Email:cyeh13@jhu.edu
Phone:4105020184

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Pain is considered as one of the most important causal factors of behavioral and
psychological symptoms in patients Alzheimer's disease and related disorders (ADRD). The
investigators plan to examine the effectiveness of pain relief, pain sensory change (measured
by quantitative sensory testing) and immune biomarkers change (measured by serum biomarkers)
after the auricular point acupressure (APA). A waitlist and education control will be used to
examine the feasibility of a 4-week APA intervention. The investigators will also explore
potential analgesic pathways and underpinnings of APA on pain relief.

A waitlist and education control pilot study will be conducted to examine the feasibility of
a 4-week APA intervention. This study will be conducted in two phases. In Phase 1, following
the baseline assessment (1st home visit), participants will wait one month and will be
randomized to an APA or education control group (to control time and attention). For the
education control, each participant will be given 3 Alzheimer's Association publications
(i.e., Basics of AD; Take Care of Yourself; and Behaviors). Both groups will have 1st office
visit at pre-intervention, followed by three home visits weekly, 2nd office visit
(post-intervention). After post-intervention assessment, the education control participants
will cross over to the APA protocol. Participants at both groups will have three monthly
follow-up (3 home visits) after the completion of APA. In Phase 2, all participants will be
reassessed every three months for 6 months (2 follow-up phone surveys).

Inclusion Criteria:

- have a diagnosis of possible or probable ADRD by National Institute of Aging (NIA) and
Alzheimer's Association Guidelines,

- have a caregiver who is able to help and manage APA,

- pain that has persisted at least 3 months and pain on at least half of the days for
the previous 6 months,

- average intensity of pain ≥ 4 on a 10 point numerical pain scale in the past 7 days,

- receiving care at the Johns Hopkins Memory and Alzheimer's Treatment Center (JHMATC),
Johns Hopkins Alzheimer's disease Research Center (JHADRC),

- willing to commit to 5-weekly study visits (first office visits and followed by home
visits) by the study coordinators and two follow-up home visits (at three- and
six-months follow-up),

- have any type of dementia, mild to moderate stages (Montreal Cognitive Assessment,
MoCA, ≥ 8), (8) caregiver is willing to participate.

Exclusion Criteria:

- concurrent major psychiatric disorder (e.g. major depressive disorder (as primary
diagnosis), bipolar disorder, schizophrenia) or drug and alcohol abuse,

- severe illness or pain that would lead to significant deterioration in health, or that
would limit participation in the interventions (e.g. metastatic cancer,
musculoskeletal disorders, etc.)
We found this trial at
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Baltimore, Maryland 21205
Phone: 410-502-0184
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