N/A
N=80
Mechanisms of Affective Touch in Chronic Pain
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT04206397 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire — 66.0; 16.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- affective touch (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laura Case
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire |
66.0; 16.8 | — |
| PRIMARY Trauma History Using the Childhood Trauma Questionnaire |
61.6; 55.2 | — |
| PRIMARY Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic Pain |
8.2; 3.2 | — |
| PRIMARY Ratings of Affective Touch |
18.4; 6.7 | — |
| PRIMARY Change in Heat Pain Intensity From Before to After the Cold Water Bath |
-36.9; -24.3 | — |
| PRIMARY Change in Heat Pain Intensity From Before to After Gentle Brushing |
-1.2; -7.2 | — |
| SECONDARY Breathing Rate |
15.6; 14.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ages 18-65
- fluent in English
- physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)
Exclusion Criteria
- Sensory, motor, or anatomic differences or injuries relevant to study procedures
- Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
- Pregnancy
- Inability to rate pain or sensations
- 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).
- History of blood clots or first-degree family members with clotting disorders
- Current use of opiate medication(s)
- Contraindications to MRI if participating in pilot MRI study
- Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
- History of fainting or seizures
- History of frostbite
- Open cut or sore on hand to be immersed in cold water bath
- Fracture of limb to be immersed
- History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
Data sourced from ClinicalTrials.gov (NCT04206397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.