Back to resultsAuricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Primary Purpose
Opioid Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupressure with Vaccaria 600t ear seeds
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Use Disorder focused on measuring Chronic Pain, Opioid Use Disorder, Acupressure
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
Sites / Locations
- Atrium Health Wake Forest Baptist
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Auricular Acupressure (AA) Group
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Secondary Outcome Measures
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.
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.
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.
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."
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).
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."
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.
Full Information
NCT ID
NCT05711537
First Posted
January 25, 2023
Last Updated
September 7, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05711537
Brief Title
Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Official Title
Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Chronic Pain, Opioid Use Disorder, Acupressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Auricular Acupressure (AA) Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Auricular Acupressure with Vaccaria 600t ear seeds
Other Intervention Name(s)
vaccaria 600 t ear seeds
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores using Numerical Rating Scale (NRS)
Description
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
Time Frame
Baseline
Title
pain scores using Numerical Rating Scale (NRS)
Description
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
Time Frame
Day 1
Title
pain scores using Numerical Rating Scale (NRS)
Description
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
Time Frame
Day 2
Title
pain scores using Numerical Rating Scale (NRS)
Description
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
Time Frame
Day 3
Title
Pain, Enjoyment and General Activity (PEG) Assessment scores
Description
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
Time Frame
Baseline
Title
Pain, Enjoyment and General Activity (PEG) Assessment scores
Description
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
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Changes in amount of Opioid use
Description
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.
Time Frame
Baseline, Day 1, Day 2, and Day 3
Title
Willingness to decrease dependence scores
Description
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.
Time Frame
Day 3
Title
Generalized Anxiety Disorder (GAD-7) score changes
Description
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.
Time Frame
Baseline and Day 3
Title
Pain Catastrophizing Scale (PCS) assessments
Description
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."
Time Frame
Baseline and Day 3
Title
Auricular Acupressure Acceptability
Description
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).
Time Frame
Day 3
Title
Change in Patient Global Impression of Change (PGIC) scores
Description
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."
Time Frame
Baseline and Day 3
Title
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
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.
Time Frame
Baseline and Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Columbano, M.D.
Organizational Affiliation
Atrium Health Wake Forest Baptist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
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