Prolonged Post-surgical Pain Total Knee Arthroplasty, Prolonged Chronic Pain
Conditions
Interventions
Protocol treatment should be initiated within 28 days (the same day of the week is acceptable) after enrollment
if it is determined that protocol treatment cannot be initiated after 29 days, the protocol treatment should be discontinued and the details should be noted on the "End of Treatment Report Form" as "P
Sponsors
Matsumoto Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with chronic pain lasting more than 6 months in the knee joint after TKA surgery. (2) Patients must be at least 18 years of age, regardless of gender. (3) Patients who have had unsatisfactory results with existing pain relief therapies (NRS is 5 or more). Existing pain relief therapy here refers to NSAIDs, steroids, oral opioids, pregabalin, etc. (4) Patients with at least a 50% reduction in NRS for knee nerve blocks (superior medial, superior lateral, and inferior medial knee nerve). (5) Patients who have given their free and voluntary written consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: (1) Patients with inflammation, etc. (pyogenic arthritis, gout, pseudogout) in the knee joint. (2) Patients with systemic infection. (3) Patients with neurological pre-existing conditions (diabetic peripheral neuropathy, spondylolisthesis, or spinal fistula). (4) Patients with blood coagulation disorders or using anticoagulants. (5) Patients already receiving CRFA treatment for knee osteoarthritis. (6) Patients using a pacemaker implantable cardioverter-defibrillator, etc. (7) Other patients deemed inappropriate by the investigators in charge of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison in Numeric Rating Scale (NRS) between pre-treatment and post-6-months-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints Comparison of 2011 Knee Society Score (KSS) between pre-treatment and 6 months post-treatment. The 2011 KSS will be evaluated for each item and for the overall KSS. 2011 KSS items: Knee symptoms, satisfaction, surgical expectations, and activity The same items for the selected items of activity shall be evaluated before and after the treatment. Safety endpoints Occurrence of disease or other conditions that cannot be ruled out to be related to the test device at 6 months after treatment | — |
Contacts
Public ContactMasanori Tsubosaka
Kobe University Hospital
Outcome results
None listed