Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-09-15
2024-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Interventions
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affective touch
Various types of touch such as brushing, pressure, and tapping, as well as heat pain
Eligibility Criteria
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Inclusion Criteria
2. fluent in English
3. physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)
Exclusion Criteria
2. Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
3. Pregnancy
4. Inability to rate pain or sensations
5. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
6. History of blood clots or first-degree family members with clotting disorders
7. Current use of opiate medication(s)
8. Contraindications to MRI if participating in pilot MRI study
9. Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
10. History of fainting or seizures
11. History of frostbite
12. Open cut or sore on hand to be immersed in cold water bath
13. Fracture of limb to be immersed
14. History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
18 Years
65 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Laura Case
OTHER
Responsible Party
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Laura Case
Assistant Professor
Locations
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ACTRI
La Jolla, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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191669
Identifier Type: -
Identifier Source: org_study_id
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