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Chronic PainACUMINDNCT04089319

Acupuncture Combined With Mindfulness: ACUMIND

A study testing Music recording and Mindfulness recording in people with Chronic Pain, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Music recording and Mindfulness recording
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Sep 2019to 3 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Chronic Pain
Being tested
Music recording, Mindfulness recording
Keywords
Chronic Pain, Acupuncture, Mindfulness, Interoceptive Awareness
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music recordingOther

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

  • Mindfulness recordingOther

    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.

Study groups in NCT04089319
Study groupRoleWhat they receive
Acupuncture + mindfulnessExperimentalParticipants 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.
Receives: Other: Mindfulness recording
Acupuncture controlOtherParticipants 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.
Receives: Other: Music recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Secondary outcomes (10)

  1. Nondual Awareness Dimensional Assessment

    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.

    Measured: 2 months

  2. State Difficulties in Emotion Regulation Scale

    A questionnaire regarding emotional awareness. Scored on a 5 point Likert scale (1=not at all, 5=completely), higher values are a better outcome.

    Measured: 2 months

  3. Sensation Manikin

    A map of the body used to identify and measure areas of pleasant and unpleasant sensations.

    Measured: 2 months

  4. Retrospective Chart Review

    To discover pain medications taken by participant in the last 90 days, including opioid dose (to be converted into morphine milligram equivalent, MME).

    Measured: 3 month

  5. State Multidimensional Assessment of Interoceptive Awareness-2

    A questionnaire regarding interoceptive awareness. Scored on a 6-point Likert scale (0=never, 5=always), higher values are a better outcome.

    Measured: 2 months

  6. Acupuncture Questions

    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.

    Measured: 2 months

  7. Acceptability Questions

    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.

    Measured: 1 day

  8. Qualitative Inquiry

    A questionnaire regarding experiences during the AT. This consists of free response questions.

    Measured: 1 day

  9. Qualitative Interoceptive Awareness and Emotional Regulation

    A questionnaire regarding changes experienced since AT. This consists of open ended text questions.

    Measured: 1 day

  10. Quantitative questions

    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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start1 Sep 2019
  3. Primary completion3 May 2021
  4. Study completion3 May 2021

Why it stopped: COVID-19 prevented us from recruiting additional participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089319
Sponsor's protocol ID
00108827
Acronym
ACUMIND
Status last verified
May 2021
First submitted
10 Sep 2019
Last updated
6 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual data is not useful data at this stage.

Publications

  • 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.

    PubMed 12015237

  • 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.

    PubMed 17019673

  • 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.

    PubMed 17015072

  • 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.

    PubMed 28373890

  • 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.

    PubMed 21978149

  • 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.

    PubMed 16150816

  • 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.

    PubMed 11166473

  • 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.

    PubMed 19244085

  • 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.

    PubMed 27475042

  • 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.

    PubMed 22965186

  • 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.

    PubMed 26297011

  • 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.

    PubMed 30513087

  • 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.

    PubMed 30058824

  • 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.

    PubMed 31246748

Questions about this trial

What is this clinical trial studying?

A study testing Music recording and Mindfulness recording in people with Chronic Pain, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 prevented us from recruiting additional participants.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questions Regarding Pain and Other Symptoms (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089319, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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