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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711537
• Other study ID #: IRB00068022
• Status: Completed
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: June 2, 2023

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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