Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients

NCT ID: NCT05711537

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-06-02

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).

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Auricular Acupressure (AA) Group

Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires

Group Type: EXPERIMENTAL

Auricular Acupressure with Vaccaria 600t ear seeds

Intervention Type: DEVICE

Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.

Interventions

Auricular Acupressure with Vaccaria 600t ear seeds

Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.

Intervention Type: DEVICE

Other Intervention Names

vaccaria 600 t ear seeds

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Columbano, M.D.

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00068022

Identifier Type: -

Identifier Source: org_study_id