Feasibility and Acceptability Study of ACUAWARE

Study Overview
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Brief Summary
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This study aims to gather preliminary feasibility and acceptability data to justify a subsequent trial that would fill a gap in knowledge regarding acupuncture therapy (AT) effects on interoceptive awareness (IA) among those with chronic pain.

Detailed Description
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This study aims to gather preliminary feasibility and acceptability data to justify a subsequent trial that would fill a gap in knowledge regarding acupuncture's effects on interoceptive awareness among individuals with chronic pain. Our primary hypotheses are that (1) Feasibility: it is feasible for us to enroll and retain 70% of the patients and it is feasible to collect data from at least 70% of participants at 3-months follow-up, and (2) Acceptability: it is acceptable for 70% of licensed acupuncturists to use Acu-Track Registry; it is acceptable for 70% of patients to complete questionnaires emailed to them via Acu-Track Registry. The investigators propose to evaluate these hypotheses by conducting a prospective, pragmatic single-arm feasibility and acceptability study among individuals with chronic pain of any etiology or location, except if due to cancer. Chronic pain is defined as pain that persists or recurs for more than 3 months.

Official Title
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Collecting Pragmatic Data Via Electronic Health Records: ACUAWARE Feasibility and Acceptability Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Acupuncture therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: Age 18 or older; experiencing chronic pain, complaint of 3+ months, score of 5 or greater on a 1-10 scale; able to provide informed consent willing to sign an approved consent form that conforms to federal and institutional guidelines, English speaking and writing. Exclusion Criteria: Prior or current diagnosis of: cancer, Multiple Sclerosis (MS), any Dementia, Parkinson's Disease, Autism Spectrum Disorder, Pregnancy, Fibromyalgia, Eating Disorder, Down's Syndrome Schizophrenia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons with chronic pain<br>Standard acupuncture care will be provided to persons (n=50) with chronic pain. Standard care is defined as the care a participant was already receiving and that care will not be interrupted in any way for any study participant. | Other: Acupuncture therapy<br>* Acupuncture therapy (AT) is delivered by Licensed Acupuncturists (LAcs). Treatment plans are determined according to each patient's presentation and resulting traditional East Asian medicine (TEAM) differential diagnosis. TEAM therapeutics include AT, Chinese herbal medicine (CHM), Kampo herbal medicine, gua sha, tui na, cupping and lifestyle advice. All TEAM therapeutics are allowed in this study because it is a pragmatic, effectiveness study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility metrics - rate of enrollment | Rate of enrollment of acupuncturists and patients (frequency count) | 24 months | 
| Feasibility metrics - rate of retention | Rate of retention of acupuncturists and participants (frequency count) | 24 months | 
| Feasibility metrics - rate of questionnaire completion | Rate of questionnaire completion by participants (frequency count) | 24 months | 
| Feasibility metrics - completion rate of acupuncture therapy | Rate of completion of acupuncture therapy (AT) (frequency count) | 24 months | 
| Feasibility metrics - rate of serious adverse events | Rate of serious adverse events (frequency count) | 24 months | 
| Acceptability metrics | Acceptability ratings by licensed acupuncturists and by participants. Acceptability is asked in a binary question: Is it acceptable to you to use the Acu-Track registry? Yes/No. We define acceptable as 70% or more of licensed acupuncturists to use Acu-Track Registry; and acceptable for 70% or more of patients to complete questionnaires emailed to them via Acu-Track Registry. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2) | The MAIA-2, or Multidimensional Assessment of Interoceptive Awareness Scale, will be used to measure interoceptive awareness (IA). The MAIA-2 is comprised of 8 subscales and 37 items. Items are scored 0-5, with higher scores indicating increased IA. | 24 months | 
| Global Impression of Change (GIC) | This simple 1 question measure is a retrospective rating scale that asks the patient how much better or worse their health complaint is since beginning their course of treatments or care. It is a quick and straightforward way to gauge a patient's own belief about their improvement so far. Our PGIC scale is health complaint specific, rather than general, providing the ability to focus on monitoring a specific problem. | 24 months | 
| Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) | PROMIS-10 scoring will be used to evaluate physical function. PROMIS-10 scoring allows each of the individual items to be examined separately to provide specific information about perceptions of health (e.g., physical function, pain, fatigue, emotional distress, social health and general perceptions of health). We are using the single item: To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? Likert type scale 5-1: (5) completely, to (1) not at all. | 24 months | 
| Global Mental Health | PROMIS-10 scoring will also be used to evaluate global mental health. We are using the single item: In the past 7 days: How often have you been bothered by emotional problems such as feeling anxious, depressed, or irritable? Likert type scale 0-10: (0) no pain to (10) worst pain imaginable | 24 months | 
| Anxiety | PROMIS-10 scoring allows each of the individual items to be examined separately to provide specific information about perceptions of health. We are using the single item: In the past 7 days: How often have you been bothered by emotional problems such as feeling anxious? Likert type scale 0-10: (0) no pain to (10) worst pain imaginable. | 24 months | 
| Depression | PROMIS-10 scoring allows each of the individual items to be examined separately to provide specific information about perceptions of health. We are using the single item: In the past 7 days: How often have you been bothered by emotional problems such as feeling depressed? Likert type scale 0-10: (0) no pain to (10) worst pain imaginable. | 24 months | 
| Irritability | PROMIS-10 scoring allows each of the individual items to be examined separately to provide specific information about perceptions of health. We are using the single item: In the past 7 days: How often have you been bothered by emotional problems such as feeling irritable? Likert type scale 0-10: (0) no pain to (10) worst pain imaginable. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Feasibility study, Acceptability study