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

Johns Hopkins University

Status: Terminated

Conditions: Alzheimer Disease; Pain

Treatments: Behavioral: Auricular Point Acupressure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03393546

3R01AG056587-02S1 (U.S. NIH Grant/Contract)

IRB00168057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Auricular Point Acupressure - Interventionist

Experimental group

Description:

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.

Treatment:

Behavioral: Auricular Point Acupressure

Auricular Point Acupressure - Caregiver Training

Experimental group

Description:

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.

Treatment:

Behavioral: Auricular Point Acupressure