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

Primary Purpose

Pain, Alzheimer Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Auricular Point Acupressure

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, acupressure, alzheimer

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Johns Hopkins School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Auricular Point Acupressure - Interventionist

Auricular Point Acupressure - Caregiver Training

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

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).

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

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

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.

Change of Quality of life in Alzheimer's Disease (QOL-AD)

Total scores range from 13 to 52.

Change of Inflammatory Cytokines

It will be measured by blood serum.

Secondary Outcome Measures

Full Information

NCT ID

NCT03393546

First Posted

December 21, 2017

Last Updated

July 7, 2023

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03393546

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

PI resigned

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

March 8, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Alzheimer Disease

Keywords

pain, acupressure, alzheimer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Auricular Point Acupressure - Interventionist

Arm Type

Experimental

Arm Description

Arm Title

Auricular Point Acupressure - Caregiver Training

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Auricular Point Acupressure

Intervention Description

It includes 4 weekly auricular point acupressure treatments.

Primary Outcome Measure Information:

Title

Change of Pain intensity

Description

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

Time Frame