Feasibility and Acceptability Study of ACUAWARE
- Conditions
- Chronic Pain
- Interventions
- Other: Acupuncture therapy
- Registration Number
- NCT06145997
- Lead Sponsor
- University of Utah
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Persons with chronic pain Acupuncture therapy 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.
- Primary Outcome Measures
Name Time Method Feasibility metrics - rate of questionnaire completion 24 months Rate of questionnaire completion by participants (frequency count)
Feasibility metrics - rate of enrollment 24 months Rate of enrollment of acupuncturists and patients (frequency count)
Feasibility metrics - rate of retention 24 months Rate of retention of acupuncturists and participants (frequency count)
Feasibility metrics - completion rate of acupuncture therapy 24 months Rate of completion of acupuncture therapy (AT) (frequency count)
Acceptability metrics 24 months 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.
Feasibility metrics - rate of serious adverse events 24 months Rate of serious adverse events (frequency count)
- Secondary Outcome Measures
Name Time Method Global Mental Health 24 months 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
Depression 24 months 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.
Irritability 24 months 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.
Multidimensional Assessment of Interoceptive Awareness Scale, 2 (MAIA-2) 24 months 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.
Global Impression of Change (GIC) 24 months 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.
Anxiety 24 months 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.
Physical Function from Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) 24 months 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.
Trial Locations
- Locations (1)
University of Utah College of Nursing
🇺🇸Salt Lake City, Utah, United States