FibromyalgiaNCT03768947
Heat Therapy for Fibromyalgia
A study testing Heat therapy via hot water immersion in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Heat therapy via hot water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia
- Being tested
- Heat therapy via hot water immersion
- Keywords
- Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Heat Therapy Arm | Experimental | Participants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub). Receives: Other: Heat therapy via hot water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 Month
Secondary outcomes (2)
Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month
PROMIS (Patient-Reported Outcomes Measurement Information System) measures to be included are Depression, Anxiety, Physical Functioning, and Sleep Impairment. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
Measured: Baseline to 1 Month
Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) is a measure of symptom severity in fibromyalgia. There is a total of 21 questions and a range of scores from 0 to 210. The higher the score the more severe a person's symptoms.
Measured: Baseline and 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start19 Jul 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Chadwick, MD, MSc, FASA, University of Kansas Medical Center
- Investigators
- Andrea L Nicol, MD, Principal investigator, University of Kansas School of MedicinePaige Geiger, PhD, Principal investigator, University of Kansas School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768947
- Sponsor's protocol ID
- STUDY00142795
- Status last verified
- Jun 2022
- First submitted
- 8 Nov 2018
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21285161
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Therapy for Fibromyalgia: The Effect on Chronic Pain and Possible Mechanisms
- ClinicalTrials.gov ID
- NCT03768947
- Acronym / sponsor ID
- STUDY00142795
- Conditions
- Fibromyalgia
- Keywords
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy Arm | Experimental | Other: Heat therapy via hot water immersionParticipants in this open-label pilot study will undergo heat therapy via hot water immersion (hot-tub). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat therapy via hot water immersionParticipants 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. | Other | Heat Therapy Arm |
Primary outcome
Change from Baseline Visual Numerical Pain Score (VNS) at 1 month
Time frame: 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.
2 secondary outcomes
Change from Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) at 1 month
Time frame: Baseline to 1 Month
Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQ-R) at 1 month
Time frame: Baseline and 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 21285161Wolfe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea L Nicol, MD principal investigator
University of Kansas School of Medicine
Paige Geiger, PhD principal investigator
University of Kansas School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat therapy via hot water immersion in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Visual Numerical Pain Score (VNS) at 1 month (time frame: Baseline and 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.