Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Pain Scores Using Numerical Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain Scores Using Numerical Rating Scale (NRS)
时间窗: 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
时间窗: 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)
时间窗: Day 3
Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
次要结局
- 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)