Fibromyalgia
Conditions
Brief 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.
Interventions
BEHAVIORALaffective touch
Various types of touch such as brushing, pressure, and tapping, as well as heat pain
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Laura Case
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. ages 18-65 2. fluent in English 3. physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)
Exclusion criteria
1. Sensory, motor, or anatomic differences or injuries relevant to study procedures 2. Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis) 3. Pregnancy 4. Inability to rate pain or sensations 5. 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). 6. History of blood clots or first-degree family members with clotting disorders 7. Current use of opiate medication(s) 8. Contraindications to MRI if participating in pilot MRI study 9. Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale 10. History of fainting or seizures 11. History of frostbite 12. Open cut or sore on hand to be immersed in cold water bath 13. Fracture of limb to be immersed 14. History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic Pain | 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. |
| Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire | 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. |
| Trauma History Using the Childhood Trauma Questionnaire | 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. |
| Change in Heat Pain Intensity From Before to After Gentle Brushing | 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). |
| Ratings of Affective Touch | 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. |
| Change in Heat Pain Intensity From Before to After the Cold Water Bath | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breathing Rate | Day 1 | Respiration rate will be measured during baseline affective touch (brushing). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia Patients Adults with diagnosis of Fibromyalgia | 40 |
| Healthy Controls Healthy adults with no chronic pain | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Fibromyalgia Patients | Total | Healthy Controls |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 14.1 | 39.8 years STANDARD_DEVIATION 12.9 | 39.0 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 20 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 60 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 27 Participants | 50 Participants | 23 Participants |
| Sex/Gender, Customized female | 38 Participants | 75 Participants | 37 Participants |
| Sex/Gender, Customized male | 1 Participants | 4 Participants | 3 Participants |
| Sex/Gender, Customized other or unknown | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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).
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Change in Heat Pain Intensity From Before to After Gentle Brushing | -1.2 units on a scale | Standard Deviation 25.9 |
| Healthy Controls | Change in Heat Pain Intensity From Before to After Gentle Brushing | -7.2 units on a scale | Standard Deviation 22.9 |
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).
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Change in Heat Pain Intensity From Before to After the Cold Water Bath | -36.9 units on a scale | Standard Deviation 40.3 |
| Healthy Controls | Change in Heat Pain Intensity From Before to After the Cold Water Bath | -24.3 units on a scale | Standard Deviation 28.3 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire | 66.0 score on a scale | Standard Deviation 13.4 |
| Healthy Controls | Chronic Pain Intensity Using the Chronic Pain Grade Questionnaire | 16.8 score on a scale | Standard Deviation 14.2 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic Pain | 8.2 score on a scale | Standard Deviation 4.2 |
| Healthy Controls | Current Depression Using the Hospital Anxiety and Depression Scale Without Chronic Pain | 3.2 score on a scale | Standard Deviation 3.7 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Ratings of Affective Touch | 18.4 units on a scale | Standard Deviation 38.4 |
| Healthy Controls | Ratings of Affective Touch | 6.7 units on a scale | Standard Deviation 32.2 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Trauma History Using the Childhood Trauma Questionnaire | 61.6 score on a scale | Standard Deviation 10.5 |
| Healthy Controls | Trauma History Using the Childhood Trauma Questionnaire | 55.2 score on a scale | Standard Deviation 5.8 |
Secondary
Breathing Rate
Respiration rate will be measured during baseline affective touch (brushing).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Patients | Breathing Rate | 15.6 breathes per minute | Standard Deviation 3.9 |
| Healthy Controls | Breathing Rate | 14.7 breathes per minute | Standard Deviation 3.7 |