Acupuncture Combined With Mindfulness: ACUMIND

NCT04089319 | Terminated DMC

• 1 other identifier: 00108827
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Chronic Pain; Acupuncture; Mindfulness; Interoceptive Awareness

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (10)

• Nondual Awareness Dimensional Assessment

  2 months

• State Difficulties in Emotion Regulation Scale

  2 months

• Sensation Manikin

  2 months

• Retrospective Chart Review

  3 month

• State Multidimensional Assessment of Interoceptive Awareness-2

  2 months

Study Arms (2)

Acupuncture + mindfulness

EXPERIMENTAL

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

Acupuncture control

OTHER

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

Interventions

Music recording OTHER

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

Acupuncture control

Mindfulness recording OTHER

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 + mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patient has received 5 or more acupuncture treatments in the last 2 months.

Sponsors & Collaborators

• University of Utah: lead
• Huntsman Cancer Institute: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (16)

• Rainville P. Brain mechanisms of pain affect and pain modulation. Curr Opin Neurobiol. 2002 Apr;12(2):195-204. doi: 10.1016/s0959-4388(02)00313-6.

  PMID: 12015237 BACKGROUND

• 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. doi: 10.1002/jclp.20326.

  PMID: 17019673 BACKGROUND

• Lang PJ, Davis M. Emotion, motivation, and the brain: reflex foundations in animal and human research. Prog Brain Res. 2006;156:3-29. doi: 10.1016/S0079-6123(06)56001-7.

  PMID: 17015072 BACKGROUND

• 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.

  PMID: 28373890 BACKGROUND

• 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.

  PMID: 21978149 BACKGROUND

• 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. doi: 10.1093/eurpub/cki033. Epub 2005 Sep 8.

  PMID: 16150816 BACKGROUND

• Mantyselka P, Kumpusalo E, Ahonen R, Kumpusalo A, Kauhanen J, Viinamaki 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. doi: 10.1016/s0304-3959(00)00361-4.

  PMID: 11166473 BACKGROUND

• 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.

  PMID: 19244085 BACKGROUND

• 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.

  PMID: 27475042 BACKGROUND

• 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.

  PMID: 22965186 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26297011 BACKGROUND

• 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.

  PMID: 30513087 BACKGROUND

• 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.

  PMID: 30058824 BACKGROUND

• 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.

  PMID: 31246748 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Taylor-Swanson, PhD, MAcOM

  University of Utah College of Nursing

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 13, 2019
• Study Start: September 1, 2019
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)