Mechanisms of Affective Touch in Chronic Pain (MATCP)

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: affective touch

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura K Case, PhD; Phone Number: 858-246-4968; Email: lcase@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • ACTRI
      • Contact: Phone Number: 858-534-1251

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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 .	Day 2
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.	Day 1
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.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing rate	Respiration rate will be measured during the baseline and during the affective touch and pain trials.	Day 1 and 2

Collaborators and Investigators

• Sponsor: Laura Case
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Chronic Pain; Fibromyalgia
• Other Study ID Numbers: 191669; 4R00AT009466-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No