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

Johns Hopkins University2 sites in 1 country8 target enrollmentStarted: August 1, 2018Last updated: July 10, 2023

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Terminated
Sponsor: Johns Hopkins University
Enrollment: 8
Locations: 2
Primary Endpoint: Change of Quantitative Sensory Testing (QST)

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 and immune biomarkers change (measured by serum biomarkers) after the auricular point acupressure (APA). A waitlist 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.

Detailed Description

A waitlist pilot study will be conducted to examine the feasibility of a 4-week APA intervention. Participants and their caregivers will be enrolled into the study. Following the baseline assessment (1st home visit), participants will wait one month and will be randomized to an interventionist or caregiver-training group.

Both groups will have a home/office visit at pre-intervention, followed by three home visits weekly, and a final home/office visit at post-intervention. Participants in both groups will have 1 monthly follow-up phone call after the completion of APA.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 21 Years to 85 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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),
•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.)