Mechanisms of Affective Touch in Chronic Pain

NCT ID: NCT04206397

Last Updated: 2025-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2024-10-23

Brief Summary

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This study compares how different types of touch found in massage therapies impact pain perception, and whether these effects differ in individuals with and without chronic pain. This study also examines psychological factors that may predict differences in touch perception in individuals with chronic pain. This research will improve our understanding of whether and how massage therapies can benefit pain and health, and whether this differs in people who suffer from chronic pain.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Interventions

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affective touch

Various types of touch such as brushing, pressure, and tapping, as well as heat pain

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. ages 18-65
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

1. Sensory, motor, or anatomic differences or injuries relevant to study procedures
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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Laura Case

OTHER

Sponsor Role lead

Responsible Party

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Laura Case

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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ACTRI

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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4R00AT009466-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

191669

Identifier Type: -

Identifier Source: org_study_id

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