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

Fibromyalgia Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

We will direct a clinical trial of Whole Body Hyperthermia (WBH) for the treatment Fibromyalgia. Although we have not yet studied WBH for Fibromyalgia we have data indicating that WBH is effective for the acute treatment of major depression (MDD). Given the high overlap of symptoms between Fibromyalgia and Major Depressive Disorder (MDD), we have reasons for expecting that WBH may also be of benefit for Fibromyalgia. The primary objective of the proposed study is to determine if WBH produces improvement in core Fibromyalgia symptoms, just as it appears to do in MDD. Indeed, in preliminary studies, a single exposure to WBH resulted in a downward shift in body temperature (Figure 6) and a decrease in depressive symptoms as measured using the Center for Epidemiologic Studies Depression Scale (known as the ADS in Germany where this study was conducted) 5 days later (Figure 7). In addition, following exclusion of one patient with bronchopulmonary inflammation that did not show a decrease in body temperature following treatment, a correlation between the shift in body temperature and ΔADS approached statistical significance (Figure 9). These preliminary data are consistent with previous studies showing that 1) patients with seasonal affective disorder in winter during depression have blunted thermoregulatory cooling but have thermoregulatory cooling that is similar in efficiency to control subjects after successful antidepressant response to phototherapy (the retina has direct projections to DRVL serotonergic neurons), 2) ECT increases the circadian amplitude of core body temperature, and decreases mean core body temperature, particularly during the nighttime thermoregulatory cooling period, and 3) thermoregulatory cooling, as evidenced by the number of active sweat glands in depressed patients, increases upon clinical recovery, but not earlier, following ECT. We hypothesize that these relationships in preliminary data and in previous studies are due to dysfunction of the afferent signaling arm of the thermoregulatory system in MDD, specifically the warm afferent system projecting to the LPB and, secondarily, to the DRVL/VLPAG and DRI subsets of serotonergic neurons that have been implicated in anxiolytic and antidepressant actions, respectively, and to normalization of warm afferent signaling following treatment. Again given the high degree of overlap between Fibromyalgia and MDD, we expect that WBH may confer therapeutic benefits in Fibromyalgia as it appears to do in MDD.

This clinical trial will only include individuals with Fibromyalgia (i.e. no normal controls) in order to determine whether there is a significant effect of a single treatment with WBH administered in an open manner on Fibromyalgia symptoms. Based on our data from patients with MDD, we expect that if WBH has an effect on Fibromyalgia symptoms this will be apparent immediately after the treatment and will persist for at least a week. Therefore we will assess Fibromyalgia symptoms prior to and at 1 and 2 weeks following a single treatment with WBH. To evaluate whether treatment effects are longer lasting we will also assess symptoms two weeks following the WBH treatment.

Useful preliminary results were obtained from a pilot study comparing mildly to severely depressed patients receiving hyperthermic treatment (N=11) to depressed patients receiving psychotherapy as usual (N=3). Baseline scores on the German language ADS depression scale were similar for the two groups (mean=30.64, sd=9.18, N=11, vs. mean =32.33, sd=17.04, N=3). Raw change on the ADS was significantly greater for the hyperthermia group (mean=-11.91, sd=6.55, N=11, vs. mean=-1.33, sd=4.51, N=3; t=2.60, df=12, P=0.023), resulting in a very large standardized treatment difference (Cohen d) of 1.69 (95% CI=1.00 - 2.48). Percent change was also significant (mean=-39.4, sd=18.9, N=11, vs. mean=-8.6, sd=17.0, N=3; t=2.54; df=12, P=0.026), for a Cohen d of 1.66 (95% CI=0.93 - 2.39). The percentage of the hyperthermia vs. psychotherapy group achieving a clinical response (>50% reduction from baseline) was 27.3% vs. 0%, and the percentage achieving at least a partial response (>25% improvement) was 81.8% vs. 33.3%.

These data suggest that our proposed sample size of 10 individuals with Fibromyalgia should be sufficient to identify a potential therapeutic effect, assuming that such an effect would be of similar magnitude to the effect seen in MDD. To obtain a cohort of 10 subjects with complete baseline and post-treatment data we anticipate enrolling between 12 and 15 subjects. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT02332694
• Study type: Interventional
• Source: University of Arizona
• Status: Withdrawn
• Phase: N/A
• Start date: February 2015