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Acupuncture Combined With Mindfulness: ACUMIND (ACUMIND)

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ClinicalTrials.gov Identifier: NCT04089319
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Huntsman Cancer Institute
Information provided by (Responsible Party):
Lisa J Taylor-Swanson, University of Utah

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

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Music recording Other: Mindfulness recording Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Acupuncture Combined With Mindfulness in the Context of Chronic Pain
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Other: Mindfulness recording
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. Sensation Manikin [ Time Frame: 2 months ]
    A map of the body used to identify and measure areas of pleasant and unpleasant sensations.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. Qualitative Inquiry [ Time Frame: 1 day ]
    A questionnaire regarding experiences during the AT. This consists of free response questions.

  9. Qualitative Interoceptive Awareness and Emotional Regulation [ Time Frame: 1 day ]
    A questionnaire regarding changes experienced since AT. This consists of open ended text questions.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089319


Contacts
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Contact: Lisa Taylor-Swanson, PhD, MAcOM 8015855486 LISA.TAYLOR-SWANSON@NURS.UTAH.EDU
Contact: Morgan Arseneau, BS morgan.arseneau@nurs.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Annie Budhathoki, LAc, DAOM    801-587-4585    Annie.Budhathoki@hci.utah.edu   
Sub-Investigator: Shelley White, PHD(C)         
Sub-Investigator: Eric Garland, PhD         
Principal Investigator: Annie Budhathoki, DAOM         
Sponsors and Collaborators
University of Utah
Huntsman Cancer Institute
Investigators
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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:
Merskey H, Bogduk N. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA, USA: International Association for the Study of Pain (IASP) Press; 1994.

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Responsible Party: Lisa J Taylor-Swanson, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04089319    
Other Study ID Numbers: 00108827
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data is not useful data at this stage.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa J Taylor-Swanson, University of Utah:
Chronic Pain
Acupuncture
Mindfulness
Interoceptive Awareness
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations