About this trial
In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Those aged 19 to 80
Anyone who can provide a consent form
A person with a life expectancy of at least 12 months
Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
Disqualifiers
Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)
allergy to iodide contrast agents that do not respond to steroids
Those with acute infection or malignancy
Trial design
Single group
Treatments tested in this trial
Transcatheter Arterial Micro-Embolization
DeviceParticipants will undergo TAME with Nexsphere-F.
Treatment groups
Trial outcomes
Primary outcomes
Rate of subjects with a 50% or more reduction in QuickDASH Score Change
Descriptive statistics (mean, standard deviation, median, minimum and maximum) are presented for each visit compared to the average change rate baseline of the QuickDASH score before and after clinical trial medical device application.
Secondary outcomes
Rate of VAS Score (patient pain intensity) Change
The rate of change of VAS Score (patient pain intensity)Score before and after application of medical devices for clinical trials.(The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).)
Rate of Changes in symptoms according to in QuickDASH Score
The rate of change of QuickDASH Score before and after application of medical devices for clinical trials.(Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaires. QuickDASH scores range from 0 (no disability) to 100 (most severe disability.))
Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
The rate of change of Patient-Rated Tennis Elbow Evaluation (PRTEE) Score before and after application of medical devices for clinical trials.((Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score).)
The rate of reduction of medication
The rate of change of medication before and after application of medical devices for clinical trials.
Other outcomes
Number of participants with abnormal cases during follow-up
Abnormal cases that occurred after the application of medical devices for clinical trials
Sponsors and contacts
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