An interventional study of Hyperthermia combined with oral febuxostat. and Febuxostat in Refractory Gout, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Treatment
Gout is a crystal-related arthropathy caused by purine metabolism disorder or decreased uric acid excretion. It can manifest as acute recurrent arthritis, tophus formation, tophaceous chronic arthritis, and urate nephropathy, with severe cases potentially leading to joint disability, renal insufficiency, and damage to other vital organs.Poor long-term control of uric acid levels may result in the progression of refractory gout in some patients, characterized by persistently elevated serum uric acid levels, recurrent acute arthritis, and multiple or progressive tophi, severely affecting quality of life and imposing a significant economic burden on patients.Currently, clinical research on refractory gout is relatively limited, and both domestic and international guidelines continue to recommend uric acid-lowering therapy to slow disease progression.However, due to poor adherence, intolerance to uric acid-lowering drugs, or dose limitations caused by coexisting chronic kidney disease, achieving target serum uric acid levels in these patients is often difficult, and their clinical symptoms are challenging to alleviate effectively.
In recent years, thermotherapy, as a non-pharmacological treatment modality, has garnered increasing attention for its effects in alleviating chronic pain, promoting blood circulation, and reducing inflammatory responses.Its primary mechanisms include: 1) increasing local temperature to influence the solubility of monosodium urate (MSU) crystals, promoting their dissolution, reducing gout attacks, and accelerating the resolution of gout flares;2) elevated local temperature promotes vasodilation and blood circulation, increasing the supply of oxygen and nutrients, facilitating the clearance of uric acid and inflammatory mediators;3) thermotherapy enhances local immune responses by boosting cellular phagocytic activity; 4) it may act as a stimulus transmitted to the central nervous system alongside pain impulses, disrupting pain transmission pathways and resulting in the attenuation or elimination of pain sensations. In recent years, thermotherapy has been widely used in clinical practice as a non-invasive, adjunctive treatment for various conditions, such as tumors, lumbar disc herniation, chronic prostatitis, pelvic inflammatory disease, endometriosis-associated dysmenorrhea, and osteoarthritis, due to its proven efficacy, non-invasive nature, and minimal adverse effects.A study from China demonstrated that thermotherapy has significant therapeutic effects on patients with acute gout attacks, effectively alleviating acute symptoms and reducing inflammatory responses. In this study, the overall clinical efficacy rate of the treatment group (thermotherapy combined with conventional therapy) was significantly higher at 90.0% compared to 72.5% in the control group. Moreover, on day 1 and day 3 post-treatment, the VAS scores of the treatment group (4.11±0.76, 3.23±0.53) were significantly lower than those of the control group (5.23±1.21, 4.23±0.76), and the treatment group had lower ESR and CRP levels than the control group after treatment (P\<0.05).Therefore, the primary aim of this study is to investigate the efficacy of thermotherapy in reducing gout attacks. However, there is currently no large-scale, multicenter clinical research evidence evaluating the clinical effectiveness of thermotherapy in patients with refractory gout.
In summary, considering the critical regulatory role of temperature in the formation and deposition of monosodium urate crystals and the fundamental principles of extracorporeal high-frequency thermotherapy, we hypothesize that extracorporeal high-frequency thermotherapy could reasonably reduce MSU crystal burden, lower uric acid levels, alleviate local inflammation, and decrease the frequency of gout attacks through its thermal effects.This study aims to evaluate the efficacy of extracorporeal high-frequency thermotherapy in patients with refractory gout through a randomized controlled trial, exploring its effects on reducing gout attack frequency, improving uric acid metabolism, and alleviating inflammation. Additionally, the study will assess the impact of thermotherapy on patients' quality of life, physical function, and metabolic parameters, with the goal of providing new effective strategies for the treatment of refractory gout in the future.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 128 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
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Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
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CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Febuxostat
Other: Hyperthermia combined with oral febuxostat.
Extracorporeal high-frequency hyperthermia combined with oral febuxostat
The control group subjects were administered oral febuxostat.
The number of gout flares during the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
The proportion of patients experiencing ≥1 or ≥2 gout flares during the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
The time to the first gout flare during the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in serum uric acid levels by the end of the treatment period
Serum uric acid levels will be measured using Uricase-UV method. The change in uric acid levels from baseline to the end of the treatment period will be analyzed.
Time frame: From enrollment to the end of treatment at 20 weeks
Proportion of patients achieving target uric acid levels by the end of the treatment period
The proportion of patients achieving a target serum uric acid level of \< 360μmol/L will be calculated at the end of the treatment period, using Uricase-UV method to assess uric acid levels.
Time frame: From enrollment to the end of treatment at 20 weeks
Percentage reduction in febuxostat dosage by the end of the treatment period
Percentage reduction in febuxostat dosage by the end of the treatment period, investigating changes in febuxostat dosage in the trial and control groups during the study.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in the volume of monosodium urate (MSU) in target joints by the end of the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in C-reactive protein (CRP) levels by the end of the treatment period
CRP will be measured using the immunoturbidimetric method, and changes from baseline to the end of the treatment period will be evaluated.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in erythrocyte sedimentation rate (ESR) by the end of the treatment period
ESR will be measured using an instrument-based method, and changes from baseline to the end of the treatment period will be assessed.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in TH1/TH2-related cytokines by the end of the treatment period
These cytokines will be measured using flow cytometry, and changes from baseline to the end of the treatment period will be evaluated.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in fasting blood glucose at the end of the treatment period
Fasting blood glucose will be measured using the glucose oxidase method, and the change from baseline to the end of the treatment period will be evaluated.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in lipid levels at the end of the treatment period
Lipid levels (including triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) will be measured using enzymatic methods or homogeneous enzymatic colorimetric methods. The overall change in lipid levels from baseline to the end of the treatment period will be assessed.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in quality of life by the end of the treatment period
Changes in quality of life assessed by the The Short-From-36 Health Survey(SF-36). The SF-36 Physical Functioning Scale ranges from 0 to 100, with higher scores indicating better physical function.
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in physical function by the end of the treatment period
Changes in physical function at the end of the treatment period were assessed using the Health Assessment Questionnaire (HAQ) Disability Index.The scale ranges from 0 to 3, with higher scores indicating worse physical function.
Time frame: From enrollment to the end of treatment at 20 weeks
Comparison of patient treatment satisfaction at the end of the treatment period.
Patient satisfaction at the end of the treatment period was assessed using the Treatment Satisfaction Questionnaire.The scale ranges from 0 to 28, with higher scores indicating greater satisfaction with the treatment.
Time frame: From enrollment to the end of treatment at 20 weeks
Incidence of adverse events
Time frame: From enrollment to the end of study at 24 weeks
No study locations are listed for this record.
Start is estimated for Nov 2024; primary completion for Jul 2026, 20 months later.
Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 20 months is below that.
Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University →