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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Alzheimer Disease
• Intervention / Treatment: Behavioral: Auricular Point Acupressure

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao Hsing Yeh, PhD; Phone Number: 4105020184; Email: cyeh13@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular Point Acupressure - Interventionist; Auricular Point Acupressure includes 4 weekly treatments (the tape and seeds will remain on ear points for 5 days. Participants will be instructed to remove both at the end of the 5th day). The treatment will be administered by the research team's trained acupressure interventionist. If participants live within 15 miles of the research team's office, they will be placed in the Interventionist or Caregiver Training arm.	Behavioral: Auricular Point Acupressure; It includes 4 weekly auricular point acupressure treatments.
Experimental: Auricular Point Acupressure - Caregiver Training; Auricular Point Acupressure includes 4 weekly treatments (the tape and seeds will remain on ear points for 5 days. Participants will be instructed to remove both at the end of the 5th day). If participants live more than 15 miles away from the research team's office, the caregiver will receive in-person training by the interventionist on how to administer the treatment to their patient for the 4 weeks of treatment. If participants live within 15 miles of the research team's office, they will be placed in the Interventionist or Caregiver Training arm.	Behavioral: Auricular Point Acupressure; It includes 4 weekly auricular point acupressure treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Pain intensity	It will be measured by Brief Pain Inventory (score 0-10 for pain intensity, with 0 for no pain and 10 for most severe pain. score 0-70 for pain interferences	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Quantitative Sensory Testing (QST)	It will be measured by cold pressor testing, conditional pain modulation, mechanical pain threshold. The percentage of change score (from each end point to baseline) will be used (0-100).	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Neuropsychiatric Inventory Questionnaire (NPI-Q)	Assess the presence (yes or no) and the severity of ten neuropsychiatric symptoms. The possible range of scores is 0-36 with 0 being least severe and 36 being most severe	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Neuropsychiatric Inventory Caregiver Distress (NPI-D)	It is used to assess caregiver's distress. The range of the scale is from 0-60 with 0 being least distress and 60 being most distress	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Caregiver Burden Interview	It will be measured using Zarit Burden.The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire . The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a scale. Response options usually range from 0 (Never) to 4 (Nearly Always) The score ranges from 0 to 48.the greater the score, the higher the burden.	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Quality of life in Alzheimer's Disease (QOL-AD)	Total scores range from 13 to 52.	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up
Change of Inflammatory Cytokines	It will be measured by blood serum.	Baseline, pre- (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), 3-month (20 weeks), 6-month (32 weeks), and 9-month (44 weeks) follow up

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Chao Hsing Yeh, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pain; acupressure; alzheimer
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: IRB00168057; 3R01AG056587-02S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No