Clinical Trial of Low-dose Radiation Therapy in Patients With Knee Osteoarthritis (LoRD-KNeA Trial) (NCT05562271) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of Low-dose Radiation Therapy in Patients With Knee Osteoarthritis (LoRD-KNeA Trial)
South Korea114 participantsStarted 2022-10-28
Plain-language summary
Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy
Who can participate
Age range50 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 50-85 years old
* Kellgren-Lawrence grade 2-3 and diagnosed as a patient with primary knee osteoarthritis according to the ACR knee OA diagnostic criteria
* Patients with VAS 40 or higher when walking, with or without medication at the time of screening
* Patients who have VAS 50 or more and 90 or less when walking at the baseline
* Among patients who were previously taking analgesic drugs at the time of screening, those with an increase in pain of 10 points or more at the baseline
* Patients who do not want to take non-narcotic analgesics, those who have failed to control their pain due to the use of non-narcotic analgesics, or candidates for invasive treatment (intra-articular injection, arthroplasty, etc.)
* A person who has a will to discontinue all pain medications except for rescue medications throughout screening, baseline, and clinical trials related to knee arthritis
* A person who gives consent to use an approved contraceptive method from screening to 3 months after the end of the clinical trial
* A person who understands the eligibility requirements for the study and has signed the consent form
Exclusion Criteria:
* A history of knee irradiation in the past
* Patients participating in other degenerative arthritis clinical trials
* Kellgren-Lawrence grade 4
* A history of malignancy within the last 5 years
* A history of knee or hip surgery in the past
* Patients who have received systemic steroid treatment or intra-articular steroid/hya…