Fibromyalgia Clinical Trial
Official title:
Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
Verified date | June 2022 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if heat therapy intervention via hot water immersion (i.e., a hot tub) is an effective treatment for patients with Fibromyalgia.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Informed consent provided by the participant - Age 18 to 65 years - Diagnosis of FM according to American College of Rheumatology 2011 self-report criteria64 - Average BPI visual numerical pain score > 4 - Stable doses of medications for at least 30 days prior to screening - Participant agrees to continue the same medication regimen for the study duration - FM patients with a sedentary lifestyle (exercise can alter heat shock protein levels) Exclusion Criteria: - Inability to provide informed consent - Age greater than 65 years - Previous history of hypotension - Pregnancy - Current clinically significant disease that would prevent safe heat therapy/hot water immersion (heart conditions such as myocardial infarction, angina, uncontrolled hypertension or kidney disease see below) - Reported previous bleeding problems - Anti-platelet medication (Plavix), Warfarin, and other anticoagulants (Eliquis, Pradaxa, and Xarelto) - Recent rectal, anal, vaginal or prostate surgery - Current litigation for fibromyalgia - Current disability proceedings - Active psychotic or suicidal symptoms - Current drug or alcohol abuse - Current regular exercise |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quantitative Sensory Testing (QST)-- Pressure pain sensitivity by Multimodal Automated Sensory Testing | Pressure pain sensitivity is measured by the Multimodal Automated Sensory Testing (MAST) System (measured at the thumbnail). It yields a pressure pain threshold value measured in kg/cm2. | Baseline and 1 Month | |
Other | Blood Analyses of Change in Baseline Heat Shock Proteins at 1 month | Heat shock proteins including Heat Shock Protein 72 (HSP72), Heat Shock Factor 25 (HSP25), and Heat Shock Factor 1 (HSF1) will be measured via Western blots and Elisa assays in serum at baseline (pre-intervention) and post-intervention (within 48 hours of completion of the one month heat therapy intervention). Each of these specific heat shock proteins is measured as a protein to total protein ratio. For example, HSP25 is measured as HSP25/total protein. | Baseline and 1 Month | |
Other | Blood Analyses of Change in Pro/Anti-inflammatory Markers at 1 month | Pro/Anti-Inflammatory markers (IL-1Ra, IL-1ß, IL-6, IL-8, IL-10, IL-18, IFN-a, TNF-a) will be measured via Western blots and Elisa assays in serum at baseline (pre-intervention) and post-intervention (within 48 hours of completion of the protocol). All markers will be measured as concentrations (nanograms/milliliter (ng/mL)) | Baseline and 1 Month | |
Primary | Change from Baseline Visual Numerical Pain Score (VNS) at 1 month | Measured by the Brief Pain Inventory (BPI). The BPI scores are a numerical rating scale and range from 0 to 10. A score of 0 is equal to no pain and a score of 10 is equal to pain as bad as you can imagine. | Baseline and 1 Month | |
Secondary | Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month | PROMIS (Patient-Reported Outcomes Measurement Information System) measures to be included are Depression, Anxiety, Physical Functioning, and Sleep Impairment. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured. | Baseline to 1 Month | |
Secondary | Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month | The Revised Fibromyalgia Impact Questionnaire (FIQ-R) is a measure of symptom severity in fibromyalgia. There is a total of 21 questions and a range of scores from 0 to 210. The higher the score the more severe a person's symptoms. | Baseline and 1 Month |
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