Heat Therapy for Fibromyalgia

Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Heat therapy via hot water immersion

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat Therapy Arm; Participants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub).	Other: Heat therapy via hot water immersion; Participants will be asked to participate in a 4-week heat therapy intervention, which consists of ~12-15 visits (45 min each) of immersion in to a hot tub.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Blood Analyses of Change in Pro/Anti-inflammatory Markers at 1 month	Pro/Anti-Inflammatory markers (IL-1Ra, IL-1β, IL-6, IL-8, IL-10, IL-18, IFN-α, TNF-α) 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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Andrea L Nicol, MD, University of Kansas School of Medicine; Principal Investigator: Paige Geiger, PhD, University of Kansas School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: STUDY00142795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No