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

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Device: Auricular Acupressure with Vaccaria 600t ear seeds

• Registration Number: NCT05711537
• Lead Sponsor: Wake Forest University Health Sciences

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).

Study Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-04-17
• Primary Completion: 2023-06-02
• Study Completion: 2023-06-02
• Results First Submitted: 2024-04-19
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Results First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Auricular Acupressure (AA) Group	Auricular Acupressure with Vaccaria 600t ear seeds	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

Primary Outcome Measures

Name	Time	Method
Pain Scores Using Numerical Rating Scale (NRS)	Day 3	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
Pain, Enjoyment and General Activity (PEG) Assessment Scores	Day 3	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.
Visual Analogue Scale (VAS)	Day 3	Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder (GAD-7) Score Changes	Baseline and Day 3	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.
Auricular Acupressure Acceptability-DAY 3-Satisfaction	Day 3	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
Auricular Acupressure Acceptability--DAY 3-future Use	Day 3	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
Changes in Amount of Opioid Use	Baseline, Day 1, Day 2, and Day 3	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.
Willingness to Decrease Dependence Scores	Day 3	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.
Change in Patient Global Impression of Change (PGIC) Scores	Baseline and Day 3	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."
Pain Catastrophizing Scale (PCS) Assessments	Baseline and Day 3	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."
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline and Day 3	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.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States