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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Day 1

Results posted on

2025-10-02

Participant Flow

Participant milestones

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

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 1

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.

Outcome measures

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 1

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.

Outcome measures

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 1

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.

Outcome measures

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 1

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.

Outcome measures

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 1

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).

Outcome measures

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 2

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).

Outcome measures

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 1

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laura Case

UC San Diego

Phone: 858-246-4968

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place