Clinical trial NCT03768947: Heat Therapy for Fibromyalgia
Official title: Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Chronic Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Visual Numerical Pain Score (VNS) at 1 month
timeFrame: Baseline and 1 Month
Secondary outcomes:
measure: Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month
timeFrame: Baseline to 1 Month
measure: Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month
timeFrame: Baseline and 1 Month
Other outcomes:
measure: Quantitative Sensory Testing (QST)-- Pressure pain sensitivity by Multimodal Automated Sensory Testing
timeFrame: Baseline and 1 Month
measure: Blood Analyses of Change in Baseline Heat Shock Proteins at 1 month
timeFrame: Baseline and 1 Month
measure: Blood Analyses of Change in Pro/Anti-inflammatory Markers at 1 month
timeFrame: Baseline and 1 Month
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas School of Medicine
name: Andrea L Nicol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas School of Medicine
name: Paige Geiger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser 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.