PainNCT03393546
Auricular Point Acupressure to Manage Pain in Patients With Alzheimer's Disease and Related Disorders
A study testing Auricular Point Acupressure in people with Pain and Alzheimer Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Pain, Alzheimer Disease
- What is being tested?
- Auricular Point Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
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.
Read the 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
- Being tested
- Auricular Point Acupressure
- Keywords
- pain, acupressure, alzheimer
- Medical subject headings
- Pain, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Point AcupressureBehavioural
It includes 4 weekly auricular point acupressure treatments.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Auricular Point Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Aug 2018
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Why it stopped: PI resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chao Hsing Yeh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393546
- Sponsor's protocol ID
- IRB00168057
- Other IDs
- 3R01AG056587-02S1
- Status last verified
- Jul 2023
- First submitted
- 21 Dec 2017
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Point Acupressure to Manage Pain in Patients With Alzheimer's Disease and Related Disorders
- ClinicalTrials.gov ID
- NCT03393546
- Acronym / sponsor ID
- IRB00168057
- Conditions
- Pain, Alzheimer Disease
- Keywords
- pain, acupressure, alzheimer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI resigned
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Point Acupressure - Interventionist | Experimental | Behavioral: Auricular Point AcupressureAuricular 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 - Caregiver Training | Experimental | Behavioral: Auricular Point AcupressureAuricular 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Point AcupressureIt includes 4 weekly auricular point acupressure treatments. | Behavioural | Auricular Point Acupressure - Caregiver Training, Auricular Point Acupressure - Interventionist |
Primary outcome
Change of Pain intensity
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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
Time frame: 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
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)
Time frame: 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
Total scores range from 13 to 52.
Change of Inflammatory Cytokines
Time frame: 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
It will be measured by blood serum.
Results and safety
The study was stopped early (reason given: PI resigned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Hsing Yeh, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Point Acupressure in people with Pain and Alzheimer Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI resigned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain intensity (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.