Clinical trial NCT06145997: Feasibility and Acceptability Study of ACUAWARE
Official title: Collecting Pragmatic Data Via Electronic Health Records: ACUAWARE Feasibility and Acceptability Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Keywords: Chronic pain
Feasibility study
Acceptability study
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Pace University
First posted: 2023-11-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility metrics - rate of enrollment
timeFrame: 24 months
measure: Feasibility metrics - rate of retention
timeFrame: 24 months
measure: Feasibility metrics - rate of questionnaire completion
timeFrame: 24 months
measure: Feasibility metrics - completion rate of acupuncture therapy
timeFrame: 24 months
measure: Feasibility metrics - rate of serious adverse events
timeFrame: 24 months
measure: Acceptability metrics
timeFrame: 24 months
Secondary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2)
timeFrame: 24 months
measure: Global Impression of Change (GIC)
timeFrame: 24 months
measure: Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
timeFrame: 24 months
measure: Global Mental Health
timeFrame: 24 months
measure: Anxiety
timeFrame: 24 months
measure: Depression
timeFrame: 24 months
measure: Irritability
timeFrame: 24 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah College of Nursing
state: Utah
Study officials:
affiliation: University of Utah College of Nursing
name: Lisa J Taylor-Swanson, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.