Acupuncture Combined With Mindfulness: ACUMIND

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

Detailed Description
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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.

Official Title
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Acupuncture Combined With Mindfulness in the Context of Chronic Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Music recording
* Other: Mindfulness recording


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture + mindfulness<br>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<br>* 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.<br>|
| Other: Acupuncture control<br>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<br>* Participants will listen to music for 45 minutes while they rest with acupuncture needles in place.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 
| 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. | 2 months | 
| Sensation Manikin | A map of the body used to identify and measure areas of pleasant and unpleasant sensations. | 2 months | 
| 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). | 3 month | 
| 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. | 2 months | 
| 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. | 2 months | 
| 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. | 1 day | 
| Qualitative Inquiry | A questionnaire regarding experiences during the AT. This consists of free response questions. | 1 day | 
| Qualitative Interoceptive Awareness and Emotional Regulation | A questionnaire regarding changes experienced since AT. This consists of open ended text questions. | 1 day | 
| 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Acupuncture, Mindfulness, Interoceptive Awareness