Mechanisms of Affective Touch in Chronic Pain

NCT04206397 | Completed Results DMC

• 2 other identifiers: 1916694R00AT009466-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (6)

• Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire

  The investigators will measure chronic pain levels using the Characteristic Pain Intensity score, a subscale of the Chronic Pain Grade Questionnaire (CPGQ). The questions that contribute to the subscale each use a scale from 0-10 where 0 is 'no pain' and 10 is 'pain as bad could be', and their mean is multiplied by 10. The intensity subscale score thus ranges from 0 to 100, where 0 would be least pain reported and 100 would be the most pain reported. 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. The total score ranges from 25-125, where 25 is the least childhood trauma (better) and 125 is the greatest childhood trauma (worse). 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 (HADS). The HADS consists of two sub scales for depression and anxiety. The depression sub scale ranges from 0 - 21 where 0 indicates no depression (better) and 21 indicates highest depression levels (worse). 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 pleasantness/unpleasantness ratings will be assessed in response to each sensory stimulus (brushing, tapping, and pressure) using a Visual Analog Scale. Anchors were defined as far left = 'extremely unpleasant' (coded as -100), midpoint = 'neutral' (coded as 0), and far right = 'extremely pleasant' (coded as 100). Affective touch perception is defined as the difference in ratings between the affective and neutral touch conditions (rating of brushing minus rating of tapping) during the Day 1 baseline and will be compared between individuals with and without chronic pain. This value ranged from 200 (brushing extremely pleasant and tapping extremely unpleasant) to -200 (tapping extremely pleasant and brushing extremely unpleasant). These values are not inherently 'better' or 'worse' but represent individual differences in preference for affective touch.

  Day 1

• Change in Heat Pain Intensity From Before to After the Cold Water Bath

  Pain intensity will be measured before and after the left hand is submerged in cold water (conditioned pain modulation task). Pain intensity will be assessed with a Visual Analog Scale. Anchors are defined as far left = 'no sensation' (coded as -100), midpoint = 'pain threshold' (coded as 0), and far right = 'intolerable pain' (coded as 100). Change in heat pain ratings after cold water bath ranges from -200 to 200 where higher scores indicate pain increases after cold water bath (worse) and lower scores indicate pain reduction (better).

  Day 1

• Change in Heat Pain Intensity From Before to After Gentle Brushing

  Pain intensity will be measured before and after gentle brushing (affective-touch-pain task) on a Visual Analog Scale. Anchors are defined as far left = 'no sensation' (coded as -100), midpoint = 'pain threshold' (coded as 0), and far right = 'intolerable pain' (coded as 100). Change in heat pain ratings after brushing ranges from -200 to 200 where higher scores indicate pain increases (worse) and lower scores indicate pain reduction (better).

  Day 2

Secondary Outcomes (1)

• Breathing Rate

  Day 1

Interventions

affective touch BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laura Case: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

ACTRI

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Laura Case
• Organization: UC San Diego

lcase@health.ucsd.edu

858-246-4968

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 20, 2019
• Study Start: September 15, 2021
• Primary Completion: October 21, 2024
• Study Completion: October 23, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)