Feasibility and Acceptability Study of ACUAWARE

Chronic Pain Clinical Trial

— ACUAWARE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145997
• Other study ID #: ACUAWARE
• Status: Not yet recruiting
• Start date: December 15, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: December 2023
• Source: University of Utah
• Contact: Lisa J Taylor-Swanson, PHD
• Phone: 8015855486
• Email: lisa.taylor-swanson[@]nurs.utah.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Pace University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility metrics - rate of enrollment	Rate of enrollment of acupuncturists and patients (frequency count)	24 months
Primary	Feasibility metrics - rate of retention	Rate of retention of acupuncturists and participants (frequency count)	24 months
Primary	Feasibility metrics - rate of questionnaire completion	Rate of questionnaire completion by participants (frequency count)	24 months
Primary	Feasibility metrics - completion rate of acupuncture therapy	Rate of completion of acupuncture therapy (AT) (frequency count)	24 months
Primary	Feasibility metrics - rate of serious adverse events	Rate of serious adverse events (frequency count)	24 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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