Clinical trial NCT05711537: Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Official title: Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Chronic Pain
Opioid Use Disorder
Acupressure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic pain/addiction medicine service is consulted
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if the addition of auricular acupressure to the typical pharmacological regimen given to patients on the chronic pain/addiction service will lower pain scores and decrease pain medication usage.

Detailed description: Participants will be asked to complete baseline questionnaires. After completion, a study interventionist will place 10 adhesive acupressure pads./seeds on the participant's ears, 5 acupressure pads per ear. The pads will be placed on specific sites of the ear that are thought to help with pain and overall well-being. Over the course of 3 days, participants will be asked to apply a small amount of pressure with their finger to each of the pads and answer study questionnaires.

This feasibility trial is being performed in collaboration with the Battlefield Auricular Acupressure (BAApress) Training and Intervention Fidelity study (IRB00084011).

Eligibility criteria: Inclusion Criteria:

* Age \> or equal to 18
* History of documented chronic pain with or without opioid use disorder (Polysubstance abuse or opioid use disorder or opioid narcotic use documented as home medication)
* Estimated length of stay (admission) at least 5 days at the time of recruitment
* Able to read and understand informed consent form

Exclusion Criteria:

* Patient refusal
* Patients with a known history of leaving against medical advice (AMA)
* only English-speaking participants will be eligible.
* Inability to communicate via telephone
* Participants with a history of skin disease (e.g., psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on ear,
* Cognitive impairment (delirium, dementia)
* Physical impairment preventing them from applying pressure to the beads
* Patients with cardiac pacemakers (contraindication to POINTER PAL)
* Use of some types of hearing aids (obstructing the placement of beads)
* Any chronic or acute illness or psychiatric conditions that would impact adherence to the study requirements

Primary outcomes:
measure: Pain Scores Using Numerical Rating Scale (NRS)
timeFrame: Baseline
measure: Pain Scores Using Numerical Rating Scale (NRS)
timeFrame: Day 1
measure: Pain Scores Using Numerical Rating Scale (NRS)
timeFrame: Day 2
measure: Pain Scores Using Numerical Rating Scale (NRS)
timeFrame: Day 3
measure: Pain, Enjoyment and General Activity (PEG) Assessment Scores
timeFrame: Baseline
measure: Pain, Enjoyment and General Activity (PEG) Assessment Scores
timeFrame: Day 3
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Visual Analogue Scale (VAS)
timeFrame: Day 1
measure: Visual Analogue Scale (VAS)
timeFrame: Day 2
measure: Visual Analogue Scale (VAS)
timeFrame: Day 3
Secondary outcomes:
measure: Changes in Amount of Opioid Use
timeFrame: Baseline, Day 1, Day 2, and Day 3
measure: Willingness to Decrease Dependence Scores
timeFrame: Day 3
measure: Generalized Anxiety Disorder (GAD-7) Score Changes
timeFrame: Baseline and Day 3
measure: Pain Catastrophizing Scale (PCS) Assessments
timeFrame: Baseline and Day 3
measure: Auricular Acupressure Acceptability-DAY 3-Satisfaction
timeFrame: Day 3
measure: Auricular Acupressure Acceptability--DAY 3-future Use
timeFrame: Day 3
measure: Change in Patient Global Impression of Change (PGIC) Scores
timeFrame: Baseline and Day 3
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline and Day 3
Other outcomes:
measure: Auricular Acupressure Acceptability--Qualitative Question
timeFrame: Day 3
measure: Battlefield Auricular Acupressure (BAApress)
timeFrame: Day 1
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Heather Columbano, M.D.
role: PRINCIPAL_INVESTIGATOR
References: