Heat Therapy for Fibromyalgia
Purpose
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.
Condition
- Fibromyalgia
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Heat Therapy Arm |
Participants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub). |
|
More Details
- Status
- Completed
- Sponsor
- University of Kansas Medical Center
Study Contact
Detailed Description
Fibromyalgia (FM) is a complex and difficult-to-treat painful medical condition and is marked by chronic widespread musculoskeletal pain, decreased pain threshold, and comorbid symptomatology (e.g. fatigue, trouble thinking). Several factors appear to play a role in the pathophysiology of FM: abnormal pain processing, abnormal autonomic nervous and neuroendocrine system function, genetics, and environmental triggers. The prognosis for recovery in traditional medicine is generally poor and current pharmacological treatments for FM are often insufficient to control persistent symptoms. As such, complementary medicine and alternative lifestyle approaches are needed. Heat therapy, such as saunas and hot tubs, has been used historically for its presumed therapeutic benefits, and emerging research highlights the benefits of heat therapy on metabolic and cardiovascular disease risks. Finnish saunas, which result in total-body heating, have shown beneficial clinical effects for rheumatic patients and new studies are needed to determine if heat therapy could improve pain symptoms in patients with FM. The short-term goal of the investigators is to determine, in a pilot clinical study, that heat therapy intervention via hot water immersion is a safe and efficacious treatment for pain in patients with FM. The overall hypothesis is that heat therapy intervention will improve clinical pain severity and associated dysfunction in a cohort of FM patients and that the anti-inflammatory actions of heat shock proteins may mediate this improvement. The proposed interdisciplinary study will provide data regarding treatment efficacy and will explore potential molecular and physiologic processes that may underlie improvement in pain symptoms after heat therapy intervention for FM. Furthermore, these key pilot studies will provide important preliminary data for future studies.