Whole Body Hyperthermia (WBH) as a Rapid Treatment for Fibromyalgia

Withdrawn before enrolling · Not applicable

Conditions studied: Fibromyalgia

In brief

Fibromyalgia has become an increasingly pressing public health problem in the United States. Although some treatments exist for Fibromyalgia, many individuals suffering with Fibromyalgia do not adequately respond to currently available treatment options, highlighting the need to develop and test new interventions for the disorder. To address this pressing clinical issue, we will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms in adults suffering from Fibromyalgia. We plan to recruit individuals with Fibromyalgia who will receive a single session of WBH to determine if this single session improves Fibromyalgia symptoms and if so whether this improvement will last at least 2 weeks. To do this, the study will include self-report symptom assessments immediately before and one and two weeks after WBH. In addition blood will be collected at these time points to explore whether WBH changes immune system chemicals that are believed to contribute to fibromyalgia. We intend to conduct the study until 10 individuals with fibromyalgia have received a single treatment of WBH and have completed all pre-treatment and post-treatment assessments. Given scientific evidence from our research group that WBH may improve depression, we anticipate that it may also be of benefit or adults suffering from Fibromyalgia.

Key facts

Study ID

NCT02332694

Run by

Charles (Chuck) Raison

People needed

0

Starts

2015-02-01

Last updated by the study team

2015-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female aged 18-65.
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• A diagnosis Fibromyalgia based on a clinician's diagnosis.
• In the investigator's opinion, has met criteria for Fibromyalgia for at least 4 weeks prior to signing consent.
• Able to communicate in English with study personnel.
• For women, must not be pregnant (per urine test)

You may not qualify if…

• Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
• A current DSM-IV-TR Axis I diagnosis of Dementia; or
• Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
• A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
• A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
• A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
• Subject has met DSM-IV criteria for Substance Abuse in the month prior to screening visit
• A diagnosis of an anxiety or mood disorder that is considered by the investigator to be of greater source of distress or functional impairment than the patient's FIBROMYALGIA diagnosis. Subjects with comorbid anxiety and mood disorders not excluded above and considered to be of secondary importance will be permitted in the study.
• Participation in concurrent formal psychotherapy during the trial, or in the 2 weeks prior to the screening visit.
• Subject has a medical condition or disorder that:
• Is unstable and clinically significant, or:
• Could interfere with the accurate assessment of safety or efficacy of treatment, including:
• individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,
• individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
• individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
• hemophiliacs/individuals prone to bleeding,
• individuals with a fever the day of study intervention (if so, they will be rescheduled),
• individuals with hypersensitivity to heat,
• individuals with recent acute joint injury (i.e. arthritis),
• individuals with enclosed infections, be they dental, in joints, or in any other tissues,
• Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam.
• Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of a stable dosage of benzodiazepine or non-benzodiazepine hypnotic medications (e.g. zolpidem (Ambien), zaleplon (Sonata), eszopiclone (Lunesta), lorazepam (Ativan), diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax),
• Need for any non-protocol psychotropic medication once enrolled, with the exception of benzodiazepine or non-benzodiazepine hypnotics used at a stable dosage.
• Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
• Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial, as well as drug trials with agents that might affect mood or regulation of body temperature or core fibromyalgia symptoms

Where it is running

• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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