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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00AT009466-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| affective touch | Behavioral | Various types of touch such as brushing, pressure, and tapping, as well as heat pain |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Rate | Respiration rate will be measured during baseline affective touch (brushing). | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTRI | La Jolla | California | 92093 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibromyalgia Patients | Adults with diagnosis of Fibromyalgia |
| FG001 | Healthy Controls | Healthy adults with no chronic pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibromyalgia Patients | Adults with diagnosis of Fibromyalgia |
| BG001 | Healthy Controls | Healthy adults with no chronic pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
Day 1 and Day 2 of the study, plus any contact initiated by the participant to us until study close on October 23, 2024.
Minimal risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibromyalgia Patients | Adults with diagnosis of Fibromyalgia | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Case | UC San Diego | 858-246-4968 | lcase@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Jun 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2020 | Sep 21, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Healthy Controls |
Healthy adults with no chronic pain |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 (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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
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|
| Secondary | Breathing Rate | Respiration rate will be measured during baseline affective touch (brushing). | Several participants in each study group were excluded from analysis of breathing rate due to poor quality of respiration recordings, using standardized procedures for data quality review. | Posted | Mean | Standard Deviation | breathes per minute | Day 1 |
|
|
|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Healthy Controls | Healthy adults with no chronic pain | 0 | 40 | 0 | 40 | 0 | 40 |
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| D009422 |
| Nervous System Diseases |