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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: Auricular Acupressure with Vaccaria 600t ear seeds

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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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.; Other Names: vaccaria 600 t ear seeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Using Numerical Rating Scale (NRS)	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Baseline
Pain Scores Using Numerical Rating Scale (NRS)	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 1
Pain Scores Using Numerical Rating Scale (NRS)	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 2
Pain Scores Using Numerical Rating Scale (NRS)	In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 3
Pain, Enjoyment and General Activity (PEG) Assessment Scores	Patient reported assessment of pain intensity and interference. We will compare scores before and after initiation of Auricular Acupressure. The PEG scale consists of 3 separate numerical scales: PEG-1 What number best describes your pain this week?, PEG-2 What number describes how during the past week pain has interfered with your enjoyment of life?, and PEG-3 What number best describes how during the past week pain has interfered with your general activity? Each scale has ratings ranging from 0-10. Individuals rate their pain level concerning 3 different areas. Higher scores represent more pain and or increased enjoyment and activity interference.	Baseline
Pain, Enjoyment and General Activity (PEG) Assessment Scores	Patient reported assessment of pain intensity and interference. We will compare scores before and after initiation of Auricular Acupressure. The PEG scale consists of 3 separate numerical scales: PEG-1 What number best describes your pain this week?, PEG-2 What number describes how during the past week pain has interfered with your enjoyment of life?, and PEG-3 What number best describes how during the past week pain has interfered with your general activity? Each scale has ratings ranging from 0-10. Individuals rate their pain level concerning 3 different areas. Higher scores represent more pain and or increased enjoyment and activity interference.	Day 3
Visual Analogue Scale (VAS)	Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Baseline
Visual Analogue Scale (VAS)	Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 1
Visual Analogue Scale (VAS)	Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 2
Visual Analogue Scale (VAS)	Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)	Sleep disturbance is a patient reported assessment on the quality of their sleep - Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	Baseline and Day 3
Changes in Amount of Opioid Use	Pre-Admission Opioid requirement and change from baseline (medication used during the intervention and as reported afterwards vs. home dose before the study started) collecting type, frequency and milligram use and date and time of last use prior to admission measuring mean/median changes from Baseline to Day 3 post evaluation.	Baseline, Day 1, Day 2, and Day 3
Willingness to Decrease Dependence Scores	Assessment of patient's willingness or desire to decrease opioid dependence and usage will be assessed by asking the subject to answer (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree - A higher score denotes a greater willingness to decrease dependence.	Day 3
Generalized Anxiety Disorder (GAD-7) Score Changes	A 7 item scale to identify Generalized Anxiety Disorder symptoms of evaluation. Patients are asked to rate anxiety symptoms on a scale of 0-3. Total scores for all 7 items range from 0-21. Higher scores indicate increased severity.	Baseline and Day 3
Pain Catastrophizing Scale (PCS) Assessments	The assessment of thoughts and feelings of the patients will be assessed using questions that are rated 0 for not at all to 4 for all the time. "The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing."	Baseline and Day 3
Auricular Acupressure Acceptability-DAY 3-Satisfaction	Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure) the first was a Likert scale satisfaction question. This outcome pertains only to the following acceptability question: "How satisfied were you with how your pain has been treated?" using the Likert scale to measure "Very satisfied =5, Satisfied=4, Somewhat satisfied = 3, Somewhat dissatisfied= 2, Dissatisfied 1, Very Dissatisfied 0	Day 3
Auricular Acupressure Acceptability--DAY 3-future Use	Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The second question posed a yes/no question. This outcome pertains only to the following question: Would you consider using auricular acupressure in the future for pain or if recommended by your nurse or physician? a. No, would not use again (Score of 0) b. Maybe (Score of 1), c. Yes, I would consider using in the future (Score of 2) 3	Day 3
Change in Patient Global Impression of Change (PGIC) Scores	Patient reported assessment of improvement or decline of their pain - The patient enters his answer on a 7-point scale scored as: (1) "very much better," (2) "much better," (3) "a little better," (4) "no change," (5) "a little worse," (6) "much worse," or (7) "very much worse."	Baseline and Day 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auricular Acupressure Acceptability--Qualitative Question	Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The third question was a qualitative question: "Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure?	Day 3
Battlefield Auricular Acupressure (BAApress)	The Interventionist's (Acupressure nurse) will be asked to capture time related to completion of study tasks and other qualitative questions to assess overall feasibility.	Day 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Heather Columbano, M.D., Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Opioid Use Disorder; Acupressure
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB00068022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No