Adults 18 to 65, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Chronic Pain Intensity Using the Chronic Pain Grade QuestionnairePrimary· 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 tou
Group
Value
95% CI
Fibromyalgia Patients
66.0
± 13.4
Healthy Controls
16.8
± 14.2
Trauma History Using the Childhood Trauma QuestionnairePrimary· 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.
Group
Value
95% CI
Fibromyalgia Patients
61.6
± 10.5
Healthy Controls
55.2
± 5.8
Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic PainPrimary· 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.
Group
Value
95% CI
Fibromyalgia Patients
8.2
± 4.2
Healthy Controls
3.2
± 3.7
Ratings of Affective TouchPrimary· 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
Group
Value
95% CI
Fibromyalgia Patients
18.4
± 38.4
Healthy Controls
6.7
± 32.2
Change in Heat Pain Intensity From Before to After the Cold Water BathPrimary· 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).
Group
Value
95% CI
Fibromyalgia Patients
-36.9
± 40.3
Healthy Controls
-24.3
± 28.3
Change in Heat Pain Intensity From Before to After Gentle BrushingPrimary· 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).
Group
Value
95% CI
Fibromyalgia Patients
-1.2
± 25.9
Healthy Controls
-7.2
± 22.9
Breathing RateSecondary· Day 1
Respiration rate will be measured during baseline affective touch (brushing).
Group
Value
95% CI
Fibromyalgia Patients
15.6
± 3.9
Healthy Controls
14.7
± 3.7
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Laura Case
Last refreshed: 2 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04206397.