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Chronic PainACUAWARENCT06145997

Feasibility and Acceptability Study of ACUAWARE

An observational study of Chronic Pain, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Pain
What is being tested?
Acupuncture therapy
How many people
1 participants
Where
1 siteUnited States
Study dates
15 Dec 2023to 15 Oct 2024
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Prior or current diagnosis of:
  • cancer,
  • Multiple Sclerosis (MS),
  • any Dementia,
  • Parkinson's Disease,
  • Autism Spectrum Disorder,
Show all 11Show fewer
  • Pregnancy,
  • Fibromyalgia,
  • Eating Disorder,
  • Down's Syndrome
  • Schizophrenia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah College of Nursing

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Chronic Pain
Being tested
Acupuncture therapy
Keywords
Chronic pain, Feasibility study, Acceptability study
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture therapyOther

    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.

Study groups in NCT06145997
Study groupRoleWhat they receive
Persons with chronic painStandard 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.
Receives: Other: Acupuncture therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility metrics - rate of enrollment

    Rate of enrollment of acupuncturists and patients (frequency count)

    Measured: 24 months

  2. Feasibility metrics - rate of retention

    Rate of retention of acupuncturists and participants (frequency count)

    Measured: 24 months

  3. Feasibility metrics - rate of questionnaire completion

    Rate of questionnaire completion by participants (frequency count)

    Measured: 24 months

  4. Feasibility metrics - completion rate of acupuncture therapy

    Rate of completion of acupuncture therapy (AT) (frequency count)

    Measured: 24 months

  5. Feasibility metrics - rate of serious adverse events

    Rate of serious adverse events (frequency count)

    Measured: 24 months

  6. 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.

    Measured: 24 months

Secondary outcomes (7)

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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

    Measured: 24 months

  5. 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.

    Measured: 24 months

  6. 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.

    Measured: 24 months

  7. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2023
  2. Study start15 Dec 2023
  3. Primary completion15 Oct 2024
  4. Study completion15 Oct 2024

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06145997
Sponsor's protocol ID
00139124
Acronym
ACUAWARE
Status last verified
Mar 2025
First submitted
12 Nov 2023
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data (IPD) will be used or received in this study, thus no IPD can be made available to other researchers.

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.

    PubMed 28192793

  • 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.

    PubMed 27654341

  • 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.

    PubMed 27475042

  • 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.

    PubMed 36440402

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility metrics - rate of enrollment (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06145997, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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Feasibility and Acceptability Study of ACUAWARE | AzTrials