Feasibility and Acceptability Study of ACUAWARE

NCT06145997 | Terminated

• 1 other identifier: 00139124
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

Chronic pain; Feasibility study; Acceptability study

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2)

  24 months

• Global Impression of Change (GIC)

  24 months

• Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)

  24 months

• Global Mental Health

  24 months

• Anxiety

  24 months

Study Arms (1)

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

Interventions

Acupuncture therapy OTHER

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.

Persons with chronic pain

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Pace University: collaborator

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 84112, United States

Location

Related 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.

  PMID: 28192793 BACKGROUND

• 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.

  PMID: 27654341 BACKGROUND

• 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.

  PMID: 27475042 BACKGROUND

• 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.

  PMID: 36440402 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lisa J Taylor-Swanson, PHD

  University of Utah College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 24, 2023
• Study Start: December 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)