NCT02055235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2016

Completed
Last Updated

July 7, 2017

Status Verified

October 12, 2016

Enrollment Period

1.7 years

First QC Date

February 4, 2014

Last Update Submit

July 6, 2017

Conditions

Pain

Keywords

BrainPainYoga

Outcome Measures

Primary Outcomes (1)

  • Pain perception (pain ratings)

    22 months

Secondary Outcomes (1)

  • Brain acivations, brain anatomy, autonomic response, cortisol

    22 months

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Fillingim RB. Individual differences in pain responses. Curr Rheumatol Rep. 2005 Oct;7(5):342-7. doi: 10.1007/s11926-005-0018-7.

    PMID: 16174481BACKGROUND

  • Coghill 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.

    PMID: 12824463BACKGROUND

  • Villemure 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.

    PMID: 11839418BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary C Bushnell, Ph.D.

    National Center for Complementary and Integrative Health (NCCIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 5, 2014

Study Start

January 27, 2014

Primary Completion

October 19, 2015

Study Completion

October 12, 2016

Last Updated

July 7, 2017

Record last verified: 2016-10-12

Locations

US(1)