Feasibility and Acceptability Study of ACUAWARE (ACUAWARE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Acupuncture therapy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Lisa J Taylor-Swanson, PHD; Phone Number: 8015855486; Email: lisa.taylor-swanson@nurs.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults in the United States with chronic pain, defined as pain lasting of 3 or more months, and given a score of 5 or greater on a 1-10 scale.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Persons with chronic pain; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Pace University
• Investigators: Principal Investigator: Lisa J Taylor-Swanson, PHD, University of Utah College of Nursing

Publications and helpful links

General Publications

• Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.
• Di Lernia D, Serino S, Riva G. Pain in the body. Altered interoception in chronic pain conditions: A systematic review. Neurosci Biobehav Rev. 2016 Dec;71:328-341. doi: 10.1016/j.neubiorev.2016.09.015. Epub 2016 Sep 18.
• Grissa MH, Baccouche H, Boubaker H, Beltaief K, Bzeouich N, Fredj N, Msolli MA, Boukef R, Bouida W, Nouira S. Acupuncture vs intravenous morphine in the management of acute pain in the ED. Am J Emerg Med. 2016 Nov;34(11):2112-2116. doi: 10.1016/j.ajem.2016.07.028. Epub 2016 Jul 20.
• Teng B, Wang D, Su C, Zhou H, Wang T, Mehling WE, Hu Y. The multidimensional assessment of interoceptive awareness, version 2: Translation and psychometric properties of the Chinese version. Front Psychiatry. 2022 Nov 11;13:970982. doi: 10.3389/fpsyt.2022.970982. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chronic pain; Feasibility study; Acceptability study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ACUAWARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) will be used or received in this study, thus no IPD can be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No