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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | Day 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Columbano, M.D. | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
adverse events reported over 3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Columbano, MD | Wake Forest School of Medicine | 336-716-4498 | hcolumba@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2023 | Apr 18, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2023 | Sep 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic pain/addiction medicine service is consulted
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| 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 |
| 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 |
| 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. | Baseline and Day 3 |
| 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 |
| 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 | Day 3 |
| 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 | Day 3 |
| 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 |
| 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 |
| 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. |
| Day 1 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 1 subject withdrew participation | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| 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 | 1 subject withdrew after baseline | Posted | Mean | Standard Deviation | score on a scale | Day 2 |
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| 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 | 1 subject withdrew after baseline and 2 were discharged home on day 2 | Posted | Mean | Standard Deviation | score on a scale | Day 3 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 1 withdrew study participation after day 1 and 2 were discharged home | Posted | Mean | Standard Deviation | score on a scale | Day 3 |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | morphine mg equivalents (MME) total excluding buprenorphine | Posted | Mean | Standard Error | morphine mg equivalents | Baseline, Day 1, Day 2, and Day 3 |
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| 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. | percentage of total subjects who desire to decrease their dependency on opioids: answer as strongly disagree, neither agree or disagree, agree, or strongly agree | Posted | Number | percentage of participants | Day 3 |
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| 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. | 17 paired assessments on Day 3 | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 3 |
|
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|
| 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." | 16 paired assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 3 |
|
|
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| 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 | Posted | Number | percentage of participants | Day 3 |
|
|
|
| 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 | Posted | Number | Percentage of participants | Day 3 |
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| 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." | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 3 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 3 |
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| 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? | Not Posted | Day 3 | Participants |
| 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. | Not Posted | Day 1 | Participants |
| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 2 |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 3 |
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| 21 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Answered "Dissatisfied" |
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| Title | Measurements |
|---|---|
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