Rheumatoid arthritis, Spondyloarthritis
Conditions
Interventions
Conduct treatment with a low-frequency therapy device(JMDN code: 35372000, https://www.std.pmda.go.jp/scripts/stdDB/JMDN/stdDB_jmdn_resr.cgi?Sig=1&
Select=1&
jmdn_no=2867&
kjn_no=10123)
Sponsors
Hokkaido University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals who were 18 years or older at the time of consent. Individuals determined by their primary physician to require treatment with biological agents (patients with rheumatoid arthritis or ankylosing spondylitis). Individuals who consented to use a low-frequency therapy device daily. Individuals who, after receiving a full explanation regarding participation in this study, demonstrated sufficient understanding and provided written consent to participate based on their own free will.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: Those who have developed acute heart failure, myocardial infarction, pulmonary edema, or acute exacerbation of interstitial pneumonia within the past 3 months. Those with a history of progressive cerebral lesions. Those undergoing vagus nerve stimulation therapy. Those with a history of epilepsy. Those with a history of severe cardiovascular disease. Those with pneumothorax. Those with uncontrollable infections. Those who are pregnant or breastfeeding. Those with a history of skin hypersensitivity and skin reactions to metals or other materials. Those who have difficulty with oral intake. Those with severe renal impairment (estimated glomerular filtration rate (eGFR) less than 30ml/min). Those using a cardiac pacemaker or implantable cardioverter-defibrillator. Those already using a low-frequency therapy device. Others who the principal investigator or co-investigator deems inappropriate as study subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Disease Activity Before and After the Use of Low-Frequency Therapy Device: Number of swollen/painful joints (before and after treatment) NRS/VAS (Numeric Rating Scale/Visual Analog Scale) (before and after treatment) CDAI/SDAI (Clinical Disease Activity Index/Simplified Disease Activity Index) (before and after treatment) ASDAS/BASDAI/BASFI (Ankylosing Spondylitis Disease Activity Score/Bath Ankylosing Spondylitis Disease Activity Index/Bath Ankylosing Spondylitis Functional Index) (before and after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison before and after use in patients with inflammatory arthritis Localization of immune cells before and after the use of a low-frequency therapy device Expression intensity of a group of molecules induced by IL-6 amplification before and after the use of a low-frequency therapy device Evaluation criteria for low-frequency therapy in patients with inflammatory arthritis Correlation of clinical and pathological factors before and after the use of a low-frequency therapy device Presence of disease-related genetic variants and their association with the disease state Correlation between the state of IL-6 amp activation and the changes after treatment in the group defined as responsive to low-frequency therapy (defined as an improvement of 20% or more in SDAI or ASDAS) and the non-responsive group Presence of adverse events during the use of a low-frequency therapy device (electrical reactions such as headaches, fatigue, itching) | — |
Countries
Japan
Contacts
Public ContactMichihito Kono
Hokkaido University Hospital Rheumatology and Nephrology
Outcome results
None listed