Acupuncture Combined With Mindfulness: ACUMIND

University of Utah30 enrolled

Overview

This study aims to gather preliminary data regarding acupuncture and mindfulness in the treatment of chronic pain.

Neither acupuncture nor mindfulness have been studied with respect to chronic pain in an outpatient integrative health (IH) oncology clinic in the USA. Likewise, the combination of acupuncture and mindfulness combined as not been studied. Given that both acupuncture and mindfulness have demonstrated some analgesic relief in an acute pain setting, each merit study for pain relief in an outpatient setting. The investigators are evaluating the impact of two different acupuncture approaches for patients reporting chronic pain. Acupuncture will be provided by a Licensed Acupuncturist for patients reporting chronic pain. Participants will be randomized to one of two treatments - acupuncture as usual or acupuncture plus mindfulness. The investigators will collect data regarding chronic pain, interoceptive awareness, emotion regulation, and acceptability. The study is open to participants with any etiology and any location of chronic pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain

Interventions

Music recordingOTHER

Participants will listen to music for 45 minutes while they rest with acupuncture needles in place.

Mindfulness recordingOTHER

Participants will listen to a recording of mindfulness for 15 minutes and then listen to music for 30 minutes while they rest with acupuncture needles in place.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is age 18 or older. * Patient is experiencing pain (rated ≥3 on a 0-10 scale) lasting for three or more months. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * ONLY FOR THOSE WITH A DIAGNOSIS OF CANCER: ECOG status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, \<50% in bed during the day). Exclusion Criteria: * Patient has received 5 or more acupuncture treatments in the last 2 months.

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Questions Regarding Pain and Other Symptoms

A questionnaire regarding pain as well as physical and mental awareness. A Likert scale 0-10 is used, where 0 is classified as "not at all" and 10 is classified "very much." Higher values are a worse outcome with questions 7-9 reverse scored.

Time frame: 2 months

Secondary Outcomes

Nondual Awareness Dimensional Assessment

A questionnaire regarding nondual awareness. Scored on a 10-point Likert scale (1=Not at all, 10=Very Much), higher values are a better outcome.

Time frame: 2 months

State Difficulties in Emotion Regulation Scale

A questionnaire regarding emotional awareness. Scored on a 5 point Likert scale (1=not at all, 5=completely), higher values are a better outcome.

Time frame: 2 months

Sensation Manikin

A map of the body used to identify and measure areas of pleasant and unpleasant sensations.

Time frame: 2 months

Retrospective Chart Review

To discover pain medications taken by participant in the last 90 days, including opioid dose (to be converted into morphine milligram equivalent, MME).

Time frame: 3 month

State Multidimensional Assessment of Interoceptive Awareness-2

A questionnaire regarding interoceptive awareness. Scored on a 6-point Likert scale (0=never, 5=always), higher values are a better outcome.

Time frame: 2 months

Acupuncture Questions

A questionnaire regarding changes in sensations experienced during the AT. This is scored on a 6-point Likert scale (0=not at all, 5=to all the time/every location), higher values are a better outcome.

Data from ClinicalTrials.gov

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