Clinical trial NCT04089319: Acupuncture Combined With Mindfulness: ACUMIND
Official title: Acupuncture Combined With Mindfulness in the Context of Chronic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Acupuncture
Mindfulness
Interoceptive Awareness
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Huntsman Cancer Institute
First posted: 2019-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Questions Regarding Pain and Other Symptoms
timeFrame: 2 months
Secondary outcomes:
measure: Nondual Awareness Dimensional Assessment
timeFrame: 2 months
measure: State Difficulties in Emotion Regulation Scale
timeFrame: 2 months
measure: Sensation Manikin
timeFrame: 2 months
measure: Retrospective Chart Review
timeFrame: 3 month
measure: State Multidimensional Assessment of Interoceptive Awareness-2
timeFrame: 2 months
measure: Acupuncture Questions
timeFrame: 2 months
measure: Acceptability Questions
timeFrame: 1 day
measure: Qualitative Inquiry
timeFrame: 1 day
measure: Qualitative Interoceptive Awareness and Emotional Regulation
timeFrame: 1 day
measure: Quantitative questions
timeFrame: 1 day
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah College of Nursing
name: Lisa Taylor-Swanson, PhD, MAcOM
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntsman Cancer Institute
name: Annie Budhathoki, LAc, DAOM
role: STUDY_DIRECTOR
affiliation: University of Utah College of Social Work, Huntsman Cancer Institute
name: Eric Garland
role: STUDY_DIRECTOR
affiliation: Huntsman Cancer Institute
name: Shelley White, PhD(C), MSW
role: STUDY_DIRECTOR
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