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

See Contacts and Locations

Sponsor:

Collaborator:

Huntsman Cancer Institute

Information provided by (Responsible Party):

Lisa J Taylor-Swanson, University of Utah

Study Description

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.

Study Design

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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

MedlinePlus related topics: Acupuncture Chronic Pain

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 :

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.
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.
Sensation Manikin [ Time Frame: 2 months ]
A map of the body used to identify and measure areas of pleasant and unpleasant sensations.
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).
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.
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.
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.
Qualitative Inquiry [ Time Frame: 1 day ]
A questionnaire regarding experiences during the AT. This consists of free response questions.
Qualitative Interoceptive Awareness and Emotional Regulation [ Time Frame: 1 day ]
A questionnaire regarding changes experienced since AT. This consists of open ended text questions.
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.

Eligibility Criteria

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.

Contacts and Locations

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

More Information

Publications:

Rainville P. Brain mechanisms of pain affect and pain modulation. Curr Opin Neurobiol. 2002 Apr;12(2):195-204. Review.

Lau MA, Bishop SR, Segal ZV, Buis T, Anderson ND, Carlson L, Shapiro S, Carmody J, Abbey S, Devins G. The Toronto Mindfulness Scale: development and validation. J Clin Psychol. 2006 Dec;62(12):1445-67.

Lang PJ, Davis M. Emotion, motivation, and the brain: reflex foundations in animal and human research. Prog Brain Res. 2006;156:3-29. Review.

Froeliger B, Mathew AR, McConnell PA, Eichberg C, Saladin ME, Carpenter MJ, Garland EL. Restructuring Reward Mechanisms in Nicotine Addiction: A Pilot fMRI Study of Mindfulness-Oriented Recovery Enhancement for Cigarette Smokers. Evid Based Complement Alternat Med. 2017;2017:7018014. doi: 10.1155/2017/7018014. Epub 2017 Mar 8.

Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770.

Koleva D, Krulichova I, Bertolini G, Caimi V, Garattini L. Pain in primary care: an Italian survey. Eur J Public Health. 2005 Oct;15(5):475-9. Epub 2005 Sep 8.

Mäntyselkä P, Kumpusalo E, Ahonen R, Kumpusalo A, Kauhanen J, Viinamäki H, Halonen P, Takala J. Pain as a reason to visit the doctor: a study in Finnish primary health care. Pain. 2001 Jan;89(2-3):175-80.

Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24.

Grissa MH, Baccouche H, Boubaker H, Beltaief K, Bzeouich N, Fredj N, Msolli MA, Boukef R, Bouida W, Nouira S. Acupuncture vs intravenous morphine in the management of acute pain in the ED. Am J Emerg Med. 2016 Nov;34(11):2112-2116. doi: 10.1016/j.ajem.2016.07.028. Epub 2016 Jul 20.

Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654. Review.

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.

Lavender JM, Tull MT, DiLillo D, Messman-Moore T, Gratz KL. Development and Validation of a State-Based Measure of Emotion Dysregulation. Assessment. 2017 Mar;24(2):197-209. doi: 10.1177/1073191115601218. Epub 2016 Jul 27.

Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

Hanley AW, Nakamura Y, Garland EL. The Nondual Awareness Dimensional Assessment (NADA): New tools to assess nondual traits and states of consciousness occurring within and beyond the context of meditation. Psychol Assess. 2018 Dec;30(12):1625-1639. doi: 10.1037/pas0000615. Epub 2018 Jul 30.

Hanley AW, Garland EL. Mapping the Affective Dimension of Embodiment With the Sensation Manikin: Validation Among Chronic Pain Patients and Modification by Mindfulness-Oriented Recovery Enhancement. Psychosom Med. 2019 Sep;81(7):612-621. doi: 10.1097/PSY.0000000000000725.

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

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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

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