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临床试验/NCT03768947
NCT03768947已完成不适用

Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Change from Baseline Visual Numerical Pain Score (VNS) at 1 month

研究概览

简要总结

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.

详细描述

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. fatigue, trouble thinking). Several factors appear to play a role in the pathophysiology of FM: abnormal pain processing, abnormal autonomic nervous and neuroendocrine system function, genetics, and environmental triggers. The prognosis for recovery in traditional medicine is generally poor and current pharmacological treatments for FM are often insufficient to control persistent symptoms. As such, complementary medicine and alternative lifestyle approaches are needed. Heat therapy, such as saunas and hot tubs, has been used historically for its presumed therapeutic benefits, and emerging research highlights the benefits of heat therapy on metabolic and cardiovascular disease risks. Finnish saunas, which result in total-body heating, have shown beneficial clinical effects for rheumatic patients and new studies are needed to determine if heat therapy could improve pain symptoms in patients with FM.

The short-term goal of the investigators is to determine, in a pilot clinical study, that heat therapy intervention via hot water immersion is a safe and efficacious treatment for pain in patients with FM. The overall hypothesis is that heat therapy intervention will improve clinical pain severity and associated dysfunction in a cohort of FM patients and that the anti-inflammatory actions of heat shock proteins may mediate this improvement. The proposed interdisciplinary study will provide data regarding treatment efficacy and will explore potential molecular and physiologic processes that may underlie improvement in pain symptoms after heat therapy intervention for FM. Furthermore, these key pilot studies will provide important preliminary data for future studies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Heat Therapy Arm

Experimental

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

干预措施: Heat therapy via hot water immersion (Other)

结局指标

主要结局

Change from Baseline Visual Numerical Pain Score (VNS) at 1 month

时间窗: Baseline and 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Chadwick, MD, MSc, FASA

Assistant Professor

University of Kansas Medical Center

研究点 (1)

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