Opioid Use Disorder
Conditions
Keywords
Chronic Pain, Opioid Use Disorder, Acupressure
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).
Interventions
DEVICEAuricular 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic pain/addiction medicine service is consulted
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Enjoyment and General Activity (PEG) Assessment Scores | Baseline | 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) | Baseline | Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible |
| Pain Scores Using Numerical Rating Scale (NRS) | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder (GAD-7) Score Changes | Baseline and Day 3 | 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. Total scores for all 7 items range from 0-21. Higher scores indicate increased severity. |
| Pain Catastrophizing Scale (PCS) Assessments | Baseline and Day 3 | 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--DAY 3-future Use | Day 3 | Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The second question posed a yes/no question. This outcome pertains only to the following question: 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 |
| Change in Patient Global Impression of Change (PGIC) Scores | Baseline and Day 3 | 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) | Baseline and Day 3 | 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. |
| Auricular Acupressure Acceptability-DAY 3-Satisfaction | Day 3 | Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure) the first was a Likert scale satisfaction question. This outcome pertains only to the following acceptability question: 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 |
| Changes in Amount of Opioid Use | Baseline, Day 1, Day 2, and Day 3 | 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 | Day 3 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Auricular Acupressure Acceptability--Qualitative Question | Day 3 | Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The third question was a qualitative question: Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure? |
| Battlefield Auricular Acupressure (BAApress) | Day 1 | The Interventionist's (Acupressure nurse) will be asked to capture time related to completion of study tasks and other qualitative questions to assess overall feasibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Auricular Acupressure (AA) Group 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
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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Intervention Auricular Acupressure (AA) Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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: 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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-1 | 7 score on a scale | Standard Deviation 1.76 |
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-2 | 7.57 score on a scale | Standard Deviation 2.36 |
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-3 | 7.71 score on a scale | Standard Deviation 2.45 |
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: 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.
Time frame: Day 3
Population: 1 withdrew study participation after day 1 and 2 were discharged home
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-1 | 6.5 score on a scale | Standard Deviation 1.86 |
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-2 | 5.89 score on a scale | Standard Deviation 3.03 |
| Intervention Auricular Acupressure (AA) Group | Pain, Enjoyment and General Activity (PEG) Assessment Scores | PEG-3 | 6.44 score on a scale | Standard Deviation 3.22 |
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. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Time frame: Day 1
Population: 1 subject withdrew participation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain Scores Using Numerical Rating Scale (NRS) | 7 score on a scale | Standard Deviation 1.86 |
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. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain Scores Using Numerical Rating Scale (NRS) | 6.62 score on a scale | Standard Deviation 1.36 |
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. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Time frame: Day 2
Population: 1 subject withdrew after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain Scores Using Numerical Rating Scale (NRS) | 7.2 score on a scale | Standard Deviation 2.22 |
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. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Time frame: Day 3
Population: 1 subject withdrew after baseline and 2 were discharged home on day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain Scores Using Numerical Rating Scale (NRS) | 6.68 score on a scale | Standard Deviation 2.26 |
Primary
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
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Visual Analogue Scale (VAS) | 70.05 score on a scale | Standard Deviation 29.31 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Visual Analogue Scale (VAS) | 65.85 score on a scale | Standard Deviation 17.71 |
Primary
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
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Visual Analogue Scale (VAS) | 65.42 score on a scale | Standard Deviation 28.08 |
Primary
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
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Visual Analogue Scale (VAS) | 70.10 score on a scale | Standard Deviation 25.91 |
Secondary
Auricular Acupressure Acceptability--DAY 3-future Use
Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The second question posed a yes/no question. This outcome pertains only to the following question: 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
Time frame: Day 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability--DAY 3-future Use | Answered No, would not use again | 15.8 Percentage of participants |
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability--DAY 3-future Use | Answered Maybe | 31.6 Percentage of participants |
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability--DAY 3-future Use | Answered Yes, would definitely consider using again | 52.6 Percentage of participants |
Secondary
Auricular Acupressure Acceptability-DAY 3-Satisfaction
Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure) the first was a Likert scale satisfaction question. This outcome pertains only to the following acceptability question: 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
Time frame: Day 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability-DAY 3-Satisfaction | Answered Very Satisfied | 21.05 percentage of participants |
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability-DAY 3-Satisfaction | Answered Satisfied | 21.05 percentage of participants |
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability-DAY 3-Satisfaction | Answered Somewhat satisfied | 47.4 percentage of participants |
| Intervention Auricular Acupressure (AA) Group | Auricular Acupressure Acceptability-DAY 3-Satisfaction | Answered Dissatisfied | 10.5 percentage of participants |
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.
Time frame: Baseline and Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Change in Patient Global Impression of Change (PGIC) Scores | 3.33 score on a scale | Standard Deviation 0.686 |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Change in Patient Global Impression of Change (PGIC) Scores | 3.22 score on a scale | Standard Deviation 0.878 |
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.
Time frame: Baseline, Day 1, Day 2, and Day 3
Population: morphine mg equivalents (MME) total excluding buprenorphine
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Changes in Amount of Opioid Use | 84.95 morphine mg equivalents | Standard Error 46.14 |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Changes in Amount of Opioid Use | 67.34 morphine mg equivalents | Standard Error 19.88 |
| Intervention Auricular Acupressure (AA) Group-DAY 2 | Changes in Amount of Opioid Use | 71.01 morphine mg equivalents | Standard Error 22.62 |
| Intervention Auricular Acupressure (AA) Group-DAY 3 | Changes in Amount of Opioid Use | 53.16 morphine mg equivalents | Standard Error 19.14 |
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.
Time frame: Baseline and Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) | 21.85 score on a scale | Standard Deviation 5.62 |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) | 17.89 score on a scale | Standard Deviation 6.32 |
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. Total scores for all 7 items range from 0-21. Higher scores indicate increased severity.
Time frame: Baseline and Day 3
Population: 17 paired assessments on Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Generalized Anxiety Disorder (GAD-7) Score Changes | 10.9 score on a scale | Standard Deviation 5.3 |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Generalized Anxiety Disorder (GAD-7) Score Changes | 9.53 score on a scale | Standard Deviation 6.12 |
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.
Time frame: Baseline and Day 3
Population: 16 paired assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Pain Catastrophizing Scale (PCS) Assessments | 23.15 score on a scale | Standard Deviation 13.83 |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Pain Catastrophizing Scale (PCS) Assessments | 24.82 score on a scale | Standard Deviation 13.39 |
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.
Time frame: Day 3
Population: percentage of total subjects who desire to decrease their dependency on opioids: answer as strongly disagree, neither agree or disagree, agree, or strongly agree
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Auricular Acupressure (AA) Group | Willingness to Decrease Dependence Scores | 15.79 percentage of participants |
| Intervention Auricular Acupressure (AA) Group-DAY 1 | Willingness to Decrease Dependence Scores | 26.32 percentage of participants |
| Intervention Auricular Acupressure (AA) Group-DAY 2 | Willingness to Decrease Dependence Scores | 21.05 percentage of participants |
| Intervention Auricular Acupressure (AA) Group-DAY 3 | Willingness to Decrease Dependence Scores | 36.84 percentage of participants |
Other Pre-specified
Auricular Acupressure Acceptability--Qualitative Question
Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The third question was a qualitative question: Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure?
Time frame: Day 3
Other Pre-specified
Battlefield Auricular Acupressure (BAApress)
The Interventionist's (Acupressure nurse) will be asked to capture time related to completion of study tasks and other qualitative questions to assess overall feasibility.
Time frame: Day 1