Acupuncture Combined With Mindfulness: ACUMIND (ACUMIND)

May 2, 2021 updated by: Lisa J Taylor-Swanson, University of Utah

Acupuncture Combined With Mindfulness in the Context of Chronic Pain

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

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acupuncture + mindfulness
Participants will receive acupuncture treatment for chronic pain. After acupuncture needles have been inserted, participants will listen to a 15-minute mindfulness recording followed by music for 30 minutes. Acupuncture needles will then be removed.
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.
OTHER: Acupuncture control
Participants will receive acupuncture treatment for chronic pain. After acupuncture needles have been inserted, participants will listen music for 45 minutes. Acupuncture needles will then be removed.
Participants will listen to music for 45 minutes while they rest with acupuncture needles in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questions Regarding Pain and Other Symptoms
Time Frame: 2 months
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nondual Awareness Dimensional Assessment
Time Frame: 2 months
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.
2 months
State Difficulties in Emotion Regulation Scale
Time Frame: 2 months
A questionnaire regarding emotional awareness. Scored on a 5 point Likert scale (1=not at all, 5=completely), higher values are a better outcome.
2 months
Sensation Manikin
Time Frame: 2 months
A map of the body used to identify and measure areas of pleasant and unpleasant sensations.
2 months
Retrospective Chart Review
Time Frame: 3 month
To discover pain medications taken by participant in the last 90 days, including opioid dose (to be converted into morphine milligram equivalent, MME).
3 month
State Multidimensional Assessment of Interoceptive Awareness-2
Time Frame: 2 months
A questionnaire regarding interoceptive awareness. Scored on a 6-point Likert scale (0=never, 5=always), higher values are a better outcome.
2 months
Acupuncture Questions
Time Frame: 2 months
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.
2 months
Acceptability Questions
Time Frame: 1 day
A questionnaire regarding the acceptability of the AT. This is scored on a 5 point Likert scale (1=completely disagree, 5=completely agree), higher values are a better outcome.
1 day
Qualitative Inquiry
Time Frame: 1 day
A questionnaire regarding experiences during the AT. This consists of free response questions.
1 day
Qualitative Interoceptive Awareness and Emotional Regulation
Time Frame: 1 day
A questionnaire regarding changes experienced since AT. This consists of open ended text questions.
1 day
Quantitative questions
Time Frame: 1 day
A questionnaire regarding overall health since AT. Questions 1-3 are scored on a Likert scale 0-10 is used where 0 is classified as "not at all" and 10 is classified "very much" with higher values indicating a better score and question 1 is reverse scored. Questions 4-8 are measured on a 5 point Likert scale (1=not at all, 5=completely) with higher values indicating a better outcome. Question 9 is scored on a 1-5 Likert scale with lower values indicating a better outcome. Questions 10-19 are scored on a 3 point Likert scale with higher values indicating a better outcome.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa Taylor-Swanson, PhD, MAcOM, University of Utah College of Nursing
  • Study Director: Annie Budhathoki, LAc, DAOM, Huntsman Cancer Institute
  • Study Director: Eric Garland, University of Utah College of Social Work, Huntsman Cancer Institute
  • Study Director: Shelley White, PhD(C), MSW, Huntsman Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

May 3, 2021

Study Completion (ACTUAL)

May 3, 2021

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (ACTUAL)

September 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00108827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data is not useful data at this stage.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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