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

NCT ID: NCT03393546

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-03-08

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.

Conditions

Pain; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular Point Acupressure

Intervention Type: BEHAVIORAL

It includes 4 weekly auricular point acupressure treatments.

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.

Group Type: EXPERIMENTAL

Auricular Point Acupressure

Intervention Type: BEHAVIORAL

It includes 4 weekly auricular point acupressure treatments.

Interventions

Auricular Point Acupressure

It includes 4 weekly auricular point acupressure treatments.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao Hsing Yeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

3R01AG056587-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00168057

Identifier Type: -

Identifier Source: org_study_id