Refractory GoutNCT06653686
Study on the Efficacy and Safety of Thermotherapy in the Treatment of Refractory Gout
A study testing Hyperthermia combined with oral febuxostat. and Febuxostat in people with Refractory Gout, run by The First Hospital of Jilin University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Gout
- What is being tested?
- Hyperthermia combined with oral febuxostat. and Febuxostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old;
- Meeting the diagnostic criteria for refractory gout, defined as fulfilling at least one of the following three conditions: 1) Blood uric acid remains ≥360 μmol/L despite adequate doses and duration of urate-lowering drugs, either alone or in combination (adequate treatment is defined as single-drug therapy at standard doses for more than 6 months, or maximum doses for more than 3 months, with blood uric acid still ≥360 μmol/L; combination therapy for more than 3 months with blood uric acid still ≥360 μmol/L); 2) More than two gout flares per year despite standardized treatment; 3) Presence of multiple or progressive tophi;
- History of at least three gouty arthritis flares in the past 12 months prior to enrollment;
- Understanding the purpose and procedures of the study and providing signed informed consent.
Who cannot join
- Acute gout flare within 2 weeks prior to screening;
- Secondary gout due to hematological diseases, chemotherapy, radiotherapy, renal failure, or medications (e.g., diuretics such as furosemide, torsemide, hydrochlorothiazide, aspirin, niacin [vitamin B3], antituberculosis drugs, immunosuppressants such as cyclosporine);
- Other secondary joint pain (e.g., joint pain caused by rheumatoid arthritis or systemic lupus erythematosus) or joint pain of unknown cause;
- Patients with cardiac, pulmonary, hepatic, or renal insufficiency; active tuberculosis; mental illness or consciousness disorders;
- Patients with bone marrow hematopoietic insufficiency; leukemia; a tendency for major bleeding; or a history of malignant tumors;
- Polyarticular gouty arthritis involving more than four joints;
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- Presence or suspicion of active or recurrent bacterial, fungal, or viral infections, including tuberculosis, HIV, or hepatitis B or C infections;
- Allergy to the study drugs; patients with heat insensitivity;
- Patients currently using mercaptopurine or azathioprine; patients taking CYP3A4 inhibitors or P-gp inhibitors;
- Major surgery within the last 3 months or unhealed surgical wounds;
- Presence of stents or metal implants;
- Local skin lesions or infections;
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout
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.
- Conditions
- Refractory Gout
- Being tested
- Hyperthermia combined with oral febuxostat., Febuxostat
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia combined with oral febuxostat.Other
Extracorporeal high-frequency hyperthermia combined with oral febuxostat
FebuxostatDrug
The control group subjects were administered oral febuxostat.
| Study group | Role | What they receive |
|---|---|---|
| Febuxostat | Active comparator | Not described Receives: Drug: Febuxostat |
| Hyperthermia combined with febuxostat | Experimental | Not described Receives: Other: Hyperthermia combined with oral febuxostat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of gout flares during the treatment period
Measured: From enrollment to the end of treatment at 20 weeks
Secondary outcomes (15)
The proportion of patients experiencing ≥1 or ≥2 gout flares during the treatment period
Measured: From enrollment to the end of treatment at 20 weeks
The time to the first gout flare during the treatment period
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 20 weeks
Incidence of adverse events
Measured: From enrollment to the end of study at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GoutStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653686
- Sponsor's protocol ID
- 2024JD0925
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout
- ClinicalTrials.gov ID
- NCT06653686
- Acronym / sponsor ID
- 2024JD0925
- Conditions
- Refractory Gout
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febuxostat | Active comparator | Drug: Febuxostat |
| Hyperthermia combined with febuxostat | Experimental | Other: Hyperthermia combined with oral febuxostat. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old;
- Meeting the diagnostic criteria for refractory gout, defined as fulfilling at least one of the following three conditions: 1) Blood uric acid remains ≥360 μmol/L despite adequate doses and duration of urate-lowering drugs, either alone or in combination (adequate treatment is defined as single-drug therapy at standard doses for more than 6 months, or maximum doses for more than 3 months, with blood uric acid still ≥360 μmol/L; combination therapy for more than 3 months with blood uric acid still ≥360 μmol/L); 2) More than two gout flares per year despite standardized treatment; 3) Presence of multiple or progressive tophi;
- History of at least three gouty arthritis flares in the past 12 months prior to enrollment;
- Understanding the purpose and procedures of the study and providing signed informed consent.
Key exclusion criteria (13 listed)
- Acute gout flare within 2 weeks prior to screening;
- Secondary gout due to hematological diseases, chemotherapy, radiotherapy, renal failure, or medications (e.g., diuretics such as furosemide, torsemide, hydrochlorothiazide, aspirin, niacin [vitamin B3], antituberculosis drugs, immunosuppressants such as cyclosporine);
- Other secondary joint pain (e.g., joint pain caused by rheumatoid arthritis or systemic lupus erythematosus) or joint pain of unknown cause;
- Patients with cardiac, pulmonary, hepatic, or renal insufficiency; active tuberculosis; mental illness or consciousness disorders;
- Patients with bone marrow hematopoietic insufficiency; leukemia; a tendency for major bleeding; or a history of malignant tumors;
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 |
|---|---|---|
| Hyperthermia combined with oral febuxostat.Extracorporeal high-frequency hyperthermia combined with oral febuxostat | Other | Hyperthermia combined with febuxostat |
| FebuxostatThe control group subjects were administered oral febuxostat. | Drug | Febuxostat |
Primary outcome
The number of gout flares during the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
15 secondary outcomes
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
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
Time frame: From enrollment to the end of treatment at 20 weeks
Percentage reduction in febuxostat dosage by the end of the treatment period
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
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
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
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in fasting blood glucose at the end of the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in lipid levels at the end of the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in quality of life by the end of the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Changes in physical function by the end of the treatment period
Time frame: From enrollment to the end of treatment at 20 weeks
Comparison of patient treatment satisfaction at the end of the treatment period.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia combined with oral febuxostat. and Febuxostat in people with Refractory Gout, run by The First Hospital of Jilin University.
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 4 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: opening soon, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Department Director (15843081103, gwang168@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of gout flares during the treatment period (time frame: From enrollment to the end of treatment at 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2024.