Ignite Creation Date:
2024-05-06 @ 2:29 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02055235
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2014-02-04
Brief Title:
Study of Pain Processing in Experienced Yoga Practitioners
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pain Processing and Pain Control in Experienced Yoga Practitioners
Status:
COMPLETED
Status Verified Date:
2016-10-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
- 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 sympatheticparasympathetic 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-AT-0054 | None | None | None |