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Heat Therapy for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03768947
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Nicol, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE July 19, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Change from Baseline Visual Numerical Pain Score (VNS) at 1 month [ Time Frame: Baseline and 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month [ Time Frame: Baseline to 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.
  • Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month [ Time Frame: Baseline and 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2018)
  • Quantitative Sensory Testing (QST)-- Pressure pain sensitivity by Multimodal Automated Sensory Testing [ Time Frame: Baseline and 1 Month ]
    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.
  • Blood Analyses of Change in Baseline Heat Shock Proteins at 1 month [ Time Frame: Baseline and 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.
  • Blood Analyses of Change in Pro/Anti-inflammatory Markers at 1 month [ Time Frame: Baseline and 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))
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Heat Therapy for Fibromyalgia
Official Title  ICMJE Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Heat Therapy Arm
Participants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub).
Intervention: Other: Heat therapy via hot water immersion
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Nicol, MD, MS 913-588-3479 anicol@kumc.edu
Contact: Miranda McMillan, MS 913-588-7630 mmcmillan3@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768947
Other Study ID Numbers  ICMJE STUDY00142795
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andrea Nicol, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea L Nicol, MD University of Kansas School of Medicine
Principal Investigator: Paige Geiger, PhD University of Kansas School of Medicine
PRS Account University of Kansas Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP