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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Alzheimer Disease

Intervention / Treatment
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* Behavioral: Auricular Point Acupressure


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Point Acupressure - Interventionist<br>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<br>* It includes 4 weekly auricular point acupressure treatments.<br>|
| Experimental: Auricular Point Acupressure - Caregiver Training<br>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<br>* It includes 4 weekly auricular point acupressure treatments.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, acupressure, alzheimer