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

NCT05711537 | Completed Results FDA Device

• 1 other identifier: IRB00068022
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Chronic Pain; Opioid Use Disorder; Acupressure

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• Changes in Amount of Opioid Use

  Baseline, Day 1, Day 2, and Day 3

• Willingness to Decrease Dependence Scores

  Day 3

• Generalized Anxiety Disorder (GAD-7) Score Changes

  Baseline and Day 3

• Pain Catastrophizing Scale (PCS) Assessments

  Baseline and Day 3

• Auricular Acupressure Acceptability-DAY 3-Satisfaction

  Day 3

Other Outcomes (2)

• Auricular Acupressure Acceptability--Qualitative Question

  Day 3

• Battlefield Auricular Acupressure (BAApress)

  Day 1

Study Arms (1)

Intervention Auricular Acupressure (AA) Group

EXPERIMENTAL

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

Interventions

Auricular Acupressure with Vaccaria 600t ear seeds DEVICE

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.

Also known as: vaccaria 600 t ear seeds

Intervention Auricular Acupressure (AA) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heather Columbano, MD
• Organization: Wake Forest School of Medicine

hcolumba@wakehealth.edu

336-716-4498

Study Officials

• Heather Columbano, M.D.

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic pain/addiction medicine service is consulted

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: April 17, 2023
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)