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Clinical Trials/NCT05711537
NCT05711537
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country21 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
Wake Forest University Health Sciences
Enrollment
21
Locations
1
Primary Endpoint
Pain Scores Using Numerical Rating Scale (NRS)
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
June 2, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Pain Scores Using Numerical Rating Scale (NRS)

Time Frame: 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

Time Frame: 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)

Time Frame: 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 Outcomes

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

Study Sites (1)

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