Back to resultsMechanisms of Affective Touch in Chronic Pain (MATCP)
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
affective touch
Sponsored by
About this trial
This is an interventional basic science trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- ages 18-65
- fluent in English
- physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)
Exclusion Criteria:
- Sensory, motor, or anatomic differences or injuries relevant to study procedures
- Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
- Pregnancy
- Inability to rate pain or sensations
- 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).
- History of blood clots or first-degree family members with clotting disorders
- Current use of opiate medication(s)
- Contraindications to MRI if participating in pilot MRI study
- Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
- History of fainting or seizures
- History of frostbite
- Open cut or sore on hand to be immersed in cold water bath
- Fracture of limb to be immersed
- History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
Sites / Locations
- ACTRIRecruiting
Outcomes
Primary Outcome Measures
Chronic pain levels using the Chronic Pain Grade Questionnaire
The investigators will measure chronic pain levels using the Chronic Pain Grade Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Trauma history using the Childhood Trauma Questionnaire
The investigators will measure trauma history using the Childhood Trauma Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Current depression using the Hospital Anxiety and Depression Scale without chronic pain
The investigators will measure current depression using the Hospital Anxiety and Depression Scale. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Ratings of affective touch
Touch pleasant/unpleasantness ratings will be assessed in response to each sensory stimulus (brushing, tapping, and pressure) using a Visual Analog Scale with anchors of "no pleasantness" to "most pleasant imaginable." Affective touch perception is the difference in ratings between the affective and neutral touch conditions during the baseline testing session and will be compared between individuals with and without chronic pain.
Ratings of Heat Pain Intensity
Pain intensity will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no pain " to "most intense pain imaginable." VAS pain ratings will be compared before the cold water bath.
Ratings of Heat Pain Intensity
Pain intensity will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no pain " to "most intense pain imaginable." VAS pain ratings will be compared before and after blocks of affective touch stimuli .
Ratings of Heat Pain Unpleasantness
Pain unpleasantness will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no unpleasantness" to "most unpleasant pain imaginable." VAS pain ratings will be compared before and after the cold water bath.
Ratings of Heat Pain Unpleasantness
Pain unpleasantness will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no unpleasantness" to "most unpleasant pain imaginable." VAS pain ratings will be compared before and after blocks of affective touch stimuli.
Secondary Outcome Measures
Breathing rate
Respiration rate will be measured during the baseline and during the affective touch and pain trials.
Full Information
NCT ID
NCT04206397
First Posted
December 5, 2019
Last Updated
March 27, 2023
Sponsor
Laura Case
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT04206397
Brief Title
Mechanisms of Affective Touch in Chronic Pain
Acronym
MATCP
Official Title
Mechanisms of Affective Touch in Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laura Case
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
affective touch
Intervention Description
Various types of touch such as brushing, pressure, and tapping, as well as heat pain
Primary Outcome Measure Information:
Title
Chronic pain levels using the Chronic Pain Grade Questionnaire
Description
The investigators will measure chronic pain levels using the Chronic Pain Grade Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Time Frame
Day 1
Title
Trauma history using the Childhood Trauma Questionnaire
Description
The investigators will measure trauma history using the Childhood Trauma Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Time Frame
Day 1
Title
Current depression using the Hospital Anxiety and Depression Scale without chronic pain
Description
The investigators will measure current depression using the Hospital Anxiety and Depression Scale. This measure will be included in a linear regression model to determine whether this measure significantly predicts differences in ratings of touch pleasantness.
Time Frame
Day 1
Title
Ratings of affective touch
Description
Touch pleasant/unpleasantness ratings will be assessed in response to each sensory stimulus (brushing, tapping, and pressure) using a Visual Analog Scale with anchors of "no pleasantness" to "most pleasant imaginable." Affective touch perception is the difference in ratings between the affective and neutral touch conditions during the baseline testing session and will be compared between individuals with and without chronic pain.
Time Frame
Day 1
Title
Ratings of Heat Pain Intensity
Description
Pain intensity will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no pain " to "most intense pain imaginable." VAS pain ratings will be compared before the cold water bath.
Time Frame
Day 1
Title
Ratings of Heat Pain Intensity
Description
Pain intensity will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no pain " to "most intense pain imaginable." VAS pain ratings will be compared before and after blocks of affective touch stimuli .
Time Frame
Day 2
Title
Ratings of Heat Pain Unpleasantness
Description
Pain unpleasantness will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no unpleasantness" to "most unpleasant pain imaginable." VAS pain ratings will be compared before and after the cold water bath.
Time Frame
Day 1
Title
Ratings of Heat Pain Unpleasantness
Description
Pain unpleasantness will be measured during the baseline and post-tests in the affective-Conditioned Pain Modulation blocks. Pain intensity will be assessed with a Visual Analog Scale with anchors from "no unpleasantness" to "most unpleasant pain imaginable." VAS pain ratings will be compared before and after blocks of affective touch stimuli.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Breathing rate
Description
Respiration rate will be measured during the baseline and during the affective touch and pain trials.
Time Frame
Day 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 18-65
fluent in English
physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)
Exclusion Criteria:
Sensory, motor, or anatomic differences or injuries relevant to study procedures
Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
Pregnancy
Inability to rate pain or sensations
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).
History of blood clots or first-degree family members with clotting disorders
Current use of opiate medication(s)
Contraindications to MRI if participating in pilot MRI study
Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
History of fainting or seizures
History of frostbite
Open cut or sore on hand to be immersed in cold water bath
Fracture of limb to be immersed
History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura K Case, PhD
Phone
858-246-4968
Email
lcase@health.ucsd.edu
Facility Information:
Facility Name
ACTRI
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
858-534-1251
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanisms of Affective Touch in Chronic Pain
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