Feasibility and Acceptability Study of ACUAWARE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-10-15

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Acupuncture therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No