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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Device: Auricular Acupressure with Vaccaria 600t ear seeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic pain/addiction medicine service is consulted
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Auricular Acupressure (AA) Group<br>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<br>* 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.<br>* Other names: vaccaria 600 t ear seeds;|

What is the study measuring?
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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, 0 and 20 or 0 and 100 that fits best to their pain intensity. 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, 0 and 20 or 0 and 100 that fits best to their pain intensity. 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, 0 and 20 or 0 and 100 that fits best to their pain intensity. 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, 0 and 20 or 0 and 100 that fits best to their pain intensity. 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. 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. 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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 | Three questions will be ask of evaluate acceptance of the intervention (Auricular Acupressure) posing a Likert scale satisfaction questions, a yes/no question and an open ended question. Responses to be analyzed quantitative and qualitatively acceptability questions: 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 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 Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure? (Each answer will be collected and assessed for future studies). | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Opioid Use Disorder, Acupressure