Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653686
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Study on the Efficacy and Safety of Thermotherapy in the Treatment of Refractory Gout
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 other vital organsPoor 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 patientsCurrently clinical research on refractory gout is relatively limited and both domestic and international guidelines continue to recommend uric acid-lowering therapy to slow disease progressionHowever 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 responsesIts 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 flares2 elevated local temperature promotes vasodilation and blood circulation increasing the supply of oxygen and nutrients facilitating the clearance of uric acid and inflammatory mediators3 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 effectsA 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 900 compared to 725 in the control group Moreover on day 1 and day 3 post-treatment the VAS scores of the treatment group 411076 323053 were significantly lower than those of the control group 523121 423076 and the treatment group had lower ESR and CRP levels than the control group after treatment P005Therefore 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 effectsThis 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
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 responsesIts 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 flares2 elevated local temperature promotes vasodilation and blood circulation increasing the supply of oxygen and nutrients facilitating the clearance of uric acid and inflammatory mediators3 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 effectsA 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 900 compared to 725 in the control group Moreover on day 1 and day 3 post-treatment the VAS scores of the treatment group 411076 323053 were significantly lower than those of the control group 523121 423076 and the treatment group had lower ESR and CRP levels than the control group after treatment P005Therefore 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 effectsThis 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None