Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heat Therapy for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768947
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Nicol, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Heat therapy via hot water immersion Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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))



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768947


Contacts
Layout table for location contacts
Contact: Andrea Nicol, MD, MS 913-588-3479 anicol@kumc.edu
Contact: Miranda McMillan, MS 913-588-7630 mmcmillan3@kumc.edu

Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Andrea Nicol, MD    913-588-3479    anicol@kumc.edu   
Contact: Miranda McMillan, MS    913-588-7630    mmcmillan3@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Andrea L Nicol, MD University of Kansas School of Medicine
Principal Investigator: Paige Geiger, PhD University of Kansas School of Medicine

Publications:
Layout table for additonal information
Responsible Party: Andrea Nicol, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03768947     History of Changes
Other Study ID Numbers: STUDY00142795
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea Nicol, MD, University of Kansas Medical Center:
Chronic Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases