PainNCT02055235
Study of Pain Processing in Experienced Yoga Practitioners
An observational study of Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Background: Different people perceive the same pain differently. Mood, attention, stress, and personality affect how we feel pain. Researchers want to know whether people who do yoga perceive pain differently than people who do not practice yoga, meditation, or martial arts. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2014to 12 Oct 2016
- Phase
- Observational
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- FOR YOGA PRACTITIONERS:
You may qualify if you are:
- at least 30 years old
- an experienced yoga practitioner and practice regularly
- fluent in English
- right-handed
- in good health
You may not qualify if you:
- have a major medical condition
- suffer from chronic pain
- are pregnant or breast-feeding
- have a fear of enclosed spaces (claustrophobia)
FOR HEALTHY CONTROLS:
You may qualify if you are:
- at least 30 years old
- fluent in English
- right-handed
- in good health
You may not qualify if you:
- practice yoga, meditation, or martial arts
- have a major medical condition
- suffer from chronic pain
- are pregnant or breast-feeding have a fear of enclosed spaces (claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pain Processing and Pain Control in Experienced Yoga Practitioners
Background:
- Different people perceive the same pain differently. Mood, attention, stress, and personality affect how we feel pain. Researchers want to know whether people who do yoga perceive pain differently than people who do not practice yoga, meditation, or martial arts. They also want to study if cortisol, a stress hormone, relates to pain or brain differences.
Read more
Objective:
- To study the effects of yoga on the body s stress response, pain perception, and the brain s structure and pain response.
Eligibility:
- Right-handed adults 30 years and older who practice yoga regularly.
- Healthy right-handed volunteers 30 years and older who do at least mild exercise but no yoga or martial arts.
Design:
- Visit 1: Participants will be screened with medical history and physical exam. They will have blood and urine tests and electrocardiogram to measure heart activity.
- At home, participants will wear a heart monitor for 1 day and collect 5 saliva samples daily for seven days.
- Visit 2: Participants will undergo tests in a chair or in a mock MRI machine. They will lie on a table that slides into a cylinder.
- A heating device will be placed on their leg and heated periodically for few seconds at a time.
- They will give saliva samples.
- Heart rate, respiration, etc. will be monitored.
- They will fill out questionnaires.
- Visit 3: Participants will answer questions and repeat Visit 2 tests. Tests will be done in the real MRI machine. The scanner makes loud knocking sounds. Participants will get earplugs. Participants will be in the scanner about 1 hour with a coil over their head.
Read the detailed description
Objective: Pain perception is characterized by substantial differences between individuals. We recently showed that a group of experienced yogis tolerated pain much longer than matched controls. To tolerate pain yogis reported using strategies involving interoceptive awareness and parasympathetic activation while nearly all controls did not. Yogis had more gray matter in multiple brain regions, but only mid-insular gray matter correlated with pain tolerance. They also had higher left intra-insular white matter connectivity than controls. Given that autonomic integration occurs in the mid-insula, these observed insular adaptations could be related to successful pain affect regulation mediated by increased interoceptive processing and parasympathetic regulation. Our findings are consistent with a recent theory suggesting that yoga s benefits are achieved by reducing allostatic load in stress response systems ( wear and tear on the body ), thus restoring optimal homeostasis. Specifically, the beneficial effects of yoga on many conditions, including chronic pain, may be attributable to increased parasympathetic activation. Indeed, all the conditions benefiting from yoga practice are exacerbated by stress and exhibit a high sympathetic/parasympathetic balance, as measured by low heart rate variability (HRV). Increased sympathetic activity is known to increase hypothalamo-pituitary-adrenal (HPA) axis function. Additionally, it has been proposed that people respond to uncertainty by activating the sympathetic nervous system, and that this default response is related to the well-known negativity bias, the tendency to prioritize negative information over positive. Yoga teaches a more neutral appraisal of the world which might be a better adaptive response to uncertainty not involving as much sympathetic activation and requiring less energy from the organism than prioritizing negative information in a reactive way. This should promote a better control over stressful events including pain. Thus, the proposed studies will first pilot the psychophysical procedures before proceeding to the full study testing general hypothesis that the differences in pain processing and the related neurostructural and neurophysiological differences expected to be found in experienced yogis are related to more flexible autonomic and HPA axis control. We will also document personality traits, including pain-related behaviors, and mental states associated with the observed differences.
Study population: In the pilot sub-study 19 experienced yogis will be compared to 19 healthy volunteers who will serve as controls. The full protocol will include 49 participants per group.
Design: A pilot sub-study will be followed by the full cross-sectional study. In the full cross-sectional study experienced yogis will be matched on a number of variables with healthy controls not practicing any type of mind-body techniques. After screening, participants will be fitted with an ambulatory electrocardiography device (Holter monitor) for 24 hours to characterize their HRV in natural settings. They will also provide saliva samples at pre-determined intervals for seven consecutive days to measure cortisol, an index of the HPA axis function. Each subject will undergo two testing sessions. Session 1 will evaluate how participants anticipate and process warm and painful stimuli in certain and uncertain contexts by measuring perception while monitoring physiological responses such as respiration, heart rate, blood pressure, skin conductance and cortisol response. In session 2, functional magnetic resonance imaging (fMRI) will be used to assess potential differences in brain resting state activity between groups, as well as to document neural responses related to the anticipation and processing of warm and painfully hot stimuli in certain and uncertain contexts using a similar paradigm as in session 1. Once again, physiological monitoring will be performed. Anatomical MRI scans will be acquired for co-registration of the fMRI findings as well as to measure gray matter volume and cortical thickness differences between groups. Questionnaires evaluating the participants mental state and personality traits will be acquired throughout the sessions.
Outcome measures: Ratings of warm and painfully hot stimuli in certain and uncertain contexts will be compared between groups. Baseline HRV and cortisol levels will also be compared between groups. Functional and anatomical MRI data will be analyzed to examine differences between yogis and healthy volunteers for 1) gray matter volume and cortical thickness; 2) thermal anticipation and thermal-evoked activation patterns in certain and uncertain contexts; 3) functional connectivity during both anticipation and processing of thermal stimuli in certain and uncertain contexts; 4) resting state activity; and 5) functional connectivity during resting state. We will examine whether the behavioral, functional, or structural differences found are related to HPA axis function, autonomic function, personality traits and mental state.
- Conditions
- Pain
- Keywords
- Brain, Pain, Yoga
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception (pain ratings)
Measured: 22 months
Secondary outcomes (1)
Brain acivations, brain anatomy, autonomic response, cortisol
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start27 Jan 2014
- Primary completion19 Oct 2015
- Study completion12 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Mary C Bushnell, Ph.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055235
- Sponsor's protocol ID
- 140054
- Other IDs
- 14-AT-0054
- Status last verified
- 12 Oct 2016
- First submitted
- 4 Feb 2014
- Last updated
- 7 Jul 2017
- Results posted
- No
Publications
Fillingim RB. Individual differences in pain responses. Curr Rheumatol Rep. 2005 Oct;7(5):342-7. doi: 10.1007/s11926-005-0018-7.
PubMed 16174481Coghill RC, McHaffie JG, Yen YF. Neural correlates of interindividual differences in the subjective experience of pain. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8538-42. doi: 10.1073/pnas.1430684100. Epub 2003 Jun 24.
PubMed 12824463Villemure C, Bushnell CM. Cognitive modulation of pain: how do attention and emotion influence pain processing? Pain. 2002 Feb;95(3):195-199. doi: 10.1016/S0304-3959(02)00007-6. No abstract available.
PubMed 11839418
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Processing and Pain Control in Experienced Yoga Practitioners
- ClinicalTrials.gov ID
- NCT02055235
- Acronym / sponsor ID
- 140054
- Conditions
- Pain
- Keywords
- Brain, Pain, Yoga
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR)
- Study start
- 27 Jan 2014
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 12 Oct 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Different people perceive the same pain differently. Mood, attention, stress, and personality affect how we feel pain. Researchers want to know whether people who do yoga perceive pain differently than people who do not practice yoga, meditation, or martial arts. They also want to study if cortisol, a stress hormone, relates to pain or brain differences.
Objective:
- To study the effects of yoga on the body s stress response, pain perception, and the brain s structure and pain response.
Eligibility:
- Right-handed adults 30 years and older who practice yoga regularly.
- Healthy right-handed volunteers 30 years and older who do at least mild exercise but no yoga or martial arts.
Design:
- Visit 1: Participants will be screened with medical history and physical exam. They will have blood and urine tests and electrocardiogram to measure heart activity.
- At home, participants will wear a heart monitor for 1 day and collect 5 saliva samples daily for seven days.
- Visit 2: Participants will undergo tests in a chair or in a mock MRI machine. They will lie on a table that slides into a cylinder.
- A heating device will be placed on their leg and heated periodically for few seconds at a time.
- They will give saliva samples.
- Heart rate, respiration, etc. will be monitored.
- They will fill out questionnaires.
- Visit 3: Participants will answer questions and repeat Visit 2 tests. Tests will be done in the real MRI machine. The scanner makes loud knocking sounds. Participants will get earplugs. Participants will be in the scanner about 1 hour with a coil over their head.
Detailed description
Objective: Pain perception is characterized by substantial differences between individuals. We recently showed that a group of experienced yogis tolerated pain much longer than matched controls. To tolerate pain yogis reported using strategies involving interoceptive awareness and parasympathetic activation while nearly all controls did not. Yogis had more gray matter in multiple brain regions, but only mid-insular gray matter correlated with pain tolerance. They also had higher left intra-insular white matter connectivity than controls. Given that autonomic integration occurs in the mid-insula, these observed insular adaptations could be related to successful pain affect regulation mediated by increased interoceptive processing and parasympathetic regulation. Our findings are consistent with a recent theory suggesting that yoga s benefits are achieved by reducing allostatic load in stress response systems ( wear and tear on the body ), thus restoring optimal homeostasis. Specifically, the beneficial effects of yoga on many conditions, including chronic pain, may be attributable to increased parasympathetic activation. Indeed, all the conditions benefiting from yoga practice are exacerbated by stress and exhibit a high sympathetic/parasympathetic balance, as measured by low heart rate variability (HRV). Increased sympathetic activity is known to increase hypothalamo-pituitary-adrenal (HPA) axis function. Additionally, it has been proposed that people respond to uncertainty by activating the sympathetic nervous system, and that this default response is related to the well-known negativity bias, the tendency to prioritize negative information over positive. Yoga teaches a more neutral appraisal of the world which might be a better adaptive response to uncertainty not involving as much sympathetic activation and requiring less energy from the organism than prioritizing negative information in a reactive way. This should promote a better control over stressful events including pain. Thus, the proposed studies will first pilot the psychophysical procedures before proceeding to the full study testing general hypothesis that the differences in pain processing and the related neurostructural and neurophysiological differences expected to be found in experienced yogis are related to more flexible autonomic and HPA axis control. We will also document personality traits, including pain-related behaviors, and mental states associated with the observed differences.
Study population: In the pilot sub-study 19 experienced yogis will be compared to 19 healthy volunteers who will serve as controls. The full protocol will include 49 participants per group.
Design: A pilot sub-study will be followed by the full cross-sectional study. In the full cross-sectional study experienced yogis will be matched on a number of variables with healthy controls not practicing any type of mind-body techniques. After screening, participants will be fitted with an ambulatory electrocardiography device (Holter monitor) for 24 hours to characterize their HRV in natural settings. They will also provide saliva samples at pre-determined intervals for seven consecutive days to measure cortisol, an index of the HPA axis function. Each subject will undergo two testing sessions. Session 1 will evaluate how participants anticipate and process warm and painful stimuli in certain and uncertain contexts by measuring perception while monitoring physiological responses such as respiration, heart rate, blood pressure, skin conductance and cortisol response. In session 2, functional magnetic resonance imaging (fMRI) will be used to assess potential differences in brain resting state activity between groups, as well as to document neural responses related to the anticipation and processing of warm and painfully hot stimuli in certain and uncertain contexts using a similar paradigm as in session 1. Once again, physiological monitoring will be performed. Anatomical MRI scans will be acquired for co-registration of the fMRI findings as well as to measure gray matter volume and cortical thickness differences between groups. Questionnaires evaluating the participants mental state and personality traits will be acquired throughout the sessions.
Outcome measures: Ratings of warm and painfully hot stimuli in certain and uncertain contexts will be compared between groups. Baseline HRV and cortisol levels will also be compared between groups. Functional and anatomical MRI data will be analyzed to examine differences between yogis and healthy volunteers for 1) gray matter volume and cortical thickness; 2) thermal anticipation and thermal-evoked activation patterns in certain and uncertain contexts; 3) functional connectivity during both anticipation and processing of thermal stimuli in certain and uncertain contexts; 4) resting state activity; and 5) functional connectivity during resting state. We will examine whether the behavioral, functional, or structural differences found are related to HPA axis function, autonomic function, personality traits and mental state.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain perception (pain ratings)
Time frame: 22 months
1 secondary outcome
Brain acivations, brain anatomy, autonomic response, cortisol
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Background: PubMed 16174481Fillingim RB. Individual differences in pain responses. Curr Rheumatol Rep. 2005 Oct;7(5):342-7. doi: 10.1007/s11926-005-0018-7.
- Background: PubMed 12824463Coghill RC, McHaffie JG, Yen YF. Neural correlates of interindividual differences in the subjective experience of pain. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8538-42. doi: 10.1073/pnas.1430684100. Epub 2003 Jun 24.
- Background: PubMed 11839418Villemure C, Bushnell CM. Cognitive modulation of pain: how do attention and emotion influence pain processing? Pain. 2002 Feb;95(3):195-199. doi: 10.1016/S0304-3959(02)00007-6. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary C Bushnell, Ph.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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?
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: finished, as of the sponsor's last update on 7 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain perception (pain ratings) (time frame: 22 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 NCT02055235, which also lists 3 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 7 Jul 2017.