Status:

COMPLETED

Heat Therapy for Fibromyalgia

Lead Sponsor:

University of Kansas Medical Center

Conditions:

Fibromyalgia

Eligibility:

All Genders

18-65 years

Phase:

NA

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. fa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 19 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 10 2020

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT03768947

Start Date

July 19 2019

End Date

March 10 2020

Last Update

June 15 2022

Active Locations (1)

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University of Kansas Medical Center

Kansas City, Kansas, United States, 66160