Mechanisms of Affective Touch in Chronic Pain

Fibromyalgia Clinical Trial

— MATCP  

Official title:

Mechanisms of Affective Touch in Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206397
• Other study ID #: 191669
• Secondary ID: 4R00AT009466-02
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Laura K Case, PhD
• Phone: 858-246-4968
• Email: lcase[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia

Intervention

Behavioral:
• affective touch
Various types of touch such as brushing, pressure, and tapping, as well as heat pain

Locations

Country	Name	City	State
United States	ACTRI	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Laura Case	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Breathing rate	Respiration rate will be measured during the baseline and during the affective touch and pain trials.	Day 1 and 2