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

NCT02332694 | Withdrawn

• 1 other identifier: IRB #14-1261-1804
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• The Fibromyalgia Impact Questionnaire (FIQ)

  Change in scores between baseline and subsequent assessments will be assessed to determine the effect of WBH on fibromyalgia symptoms.

  Screening, baseline and 1 and 2 weeks post-intervention

Secondary Outcomes (8)

• The Brief Pain Inventory (BPI)

  Screening, baseline and 1 and 2 weeks post-intervention

• Change in depression scores over time [Inventory of Depressive Symptomatology-Self Report (IDS-SR)]

  Screening, baseline and 1 and 2 weeks post-intervention

• Change in Scores on the Brief COPE Measure

  Screening, baseline and 1 and 2 weeks post-intervention

• Change in Scores on the Sheehan Disability Scale (SDS)

  Screening, baseline and 1 and 2 weeks post-intervention

• Plasma Concentrations of Biological Predictors of Response and Mechanism of Action for WBH

  Baseline and 1 and 2 weeks post-intervention

Study Arms (1)

High intensity whole-body infrared heating

EXPERIMENTAL

The participant will undergo the WBH intervention where subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C.temperature.

Device: The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation

Interventions

The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation DEVICE

The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.

High intensity whole-body infrared heating

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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,

Sponsors & Collaborators

• Charles (Chuck) Raison: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Charles Raison, MD

  University of Arizona, Department of Psychiatry, College 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: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Psychiatry; College of Medicine

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (1)