Trial Outcomes & Findings for Mechanisms of Affective Touch in Chronic Pain (NCT NCT04206397)
NCT ID: NCT04206397
Last Updated: 2025-10-02
Results Overview
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.
COMPLETED
NA
80 participants
Day 1
2025-10-02
Participant Flow
Participant milestones
| Measure |
Fibromyalgia Patients
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
Healthy adults with no chronic pain
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Affective Touch in Chronic Pain
Baseline characteristics by cohort
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
39.0 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
39.8 years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
|
Sex/Gender, Customized
female
|
38 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex/Gender, Customized
male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex/Gender, Customized
other or unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire
|
66.0 score on a scale
Standard Deviation 13.4
|
16.8 score on a scale
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Trauma History Using the Childhood Trauma Questionnaire
|
61.6 score on a scale
Standard Deviation 10.5
|
55.2 score on a scale
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic Pain
|
8.2 score on a scale
Standard Deviation 4.2
|
3.2 score on a scale
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: Day 1Touch 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.
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Ratings of Affective Touch
|
18.4 units on a scale
Standard Deviation 38.4
|
6.7 units on a scale
Standard Deviation 32.2
|
PRIMARY outcome
Timeframe: Day 1Pain 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).
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Change in Heat Pain Intensity From Before to After the Cold Water Bath
|
-36.9 units on a scale
Standard Deviation 40.3
|
-24.3 units on a scale
Standard Deviation 28.3
|
PRIMARY outcome
Timeframe: Day 2Pain 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).
Outcome measures
| Measure |
Fibromyalgia Patients
n=40 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=40 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Change in Heat Pain Intensity From Before to After Gentle Brushing
|
-1.2 units on a scale
Standard Deviation 25.9
|
-7.2 units on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Respiration rate will be measured during baseline affective touch (brushing).
Outcome measures
| Measure |
Fibromyalgia Patients
n=35 Participants
Adults with diagnosis of Fibromyalgia
|
Healthy Controls
n=33 Participants
Healthy adults with no chronic pain
|
|---|---|---|
|
Breathing Rate
|
15.6 breathes per minute
Standard Deviation 3.9
|
14.7 breathes per minute
Standard Deviation 3.7
|
Adverse Events
Fibromyalgia Patients
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place