NCT03768947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

November 8, 2018

Last Update Submit

June 14, 2022

Conditions

Fibromyalgia

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month

    Baseline to 1 Month

  • Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month

    Baseline and 1 Month

Other Outcomes (3)

  • Quantitative Sensory Testing (QST)-- Pressure pain sensitivity by Multimodal Automated Sensory Testing

    Baseline and 1 Month

  • Blood Analyses of Change in Baseline Heat Shock Proteins at 1 month

    Baseline and 1 Month

  • Blood Analyses of Change in Pro/Anti-inflammatory Markers at 1 month

    Baseline and 1 Month

Study Arms (1)

Heat Therapy Arm

EXPERIMENTAL

Participants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub).

Other: Heat therapy via hot water immersion

Interventions

Heat therapy via hot water immersionOTHER

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.

Heat Therapy Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 21285161BACKGROUND

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea L Nicol, MD

    University of Kansas School of Medicine

    PRINCIPAL INVESTIGATOR

  • Paige Geiger, PhD

    University of Kansas School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

December 7, 2018

Study Start

July 19, 2019

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

US(1)