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Mechanisms of Affective Touch in Chronic Pain (MATCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206397
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : March 29, 2023
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Laura Case, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: affective touch Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Mechanisms of Affective Touch in Chronic Pain
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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

Outcome Measures
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Primary Outcome Measures :
  1. Chronic pain levels using the Chronic Pain Grade Questionnaire [ Time Frame: Day 1 ]
    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.

  2. Trauma history using the Childhood Trauma Questionnaire [ Time Frame: Day 1 ]
    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.

  3. Current depression using the Hospital Anxiety and Depression Scale without chronic pain [ Time Frame: Day 1 ]
    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.

  4. Ratings of affective touch [ Time Frame: Day 1 ]
    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.

  5. Ratings of Heat Pain Intensity [ Time Frame: Day 1 ]
    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.

  6. Ratings of Heat Pain Intensity [ Time Frame: Day 2 ]
    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 .

  7. Ratings of Heat Pain Unpleasantness [ Time Frame: Day 1 ]
    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.

  8. Ratings of Heat Pain Unpleasantness [ Time Frame: Day 2 ]
    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 :
  1. Breathing rate [ Time Frame: Day 1 and 2 ]
    Respiration rate will be measured during the baseline and during the affective touch and pain trials.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206397


Contacts
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Contact: Laura K Case, PhD 858-246-4968 lcase@health.ucsd.edu

Locations
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United States, California
ACTRI Recruiting
La Jolla, California, United States, 92093
Contact    858-534-1251      
Sponsors and Collaborators
Laura Case
National Center for Complementary and Integrative Health (NCCIH)
  Study Documents (Full-Text)

Documents provided by Laura Case, University of California, San Diego:
Informed Consent Form  [PDF] September 18, 2020

More Information
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Responsible Party: Laura Case, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04206397    
Other Study ID Numbers: 191669
4R00AT009466-02 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases