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

NCT03393546 | Terminated

• 2 other identifiers: IRB001680573R01AG056587-02S1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Alzheimer Disease

Keywords

pain; acupressure; alzheimer

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Auricular Point Acupressure - Interventionist

EXPERIMENTAL

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

Auricular Point Acupressure - Caregiver Training

EXPERIMENTAL

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

Interventions

Auricular Point Acupressure BEHAVIORAL

It includes 4 weekly auricular point acupressure treatments.

Auricular Point Acupressure - Caregiver Training; Auricular Point Acupressure - Interventionist

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pain; Alzheimer Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chao Hsing Yeh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 8, 2018
• Study Start: August 1, 2018
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

US (1)