Clinical trial NCT05562271: Clinical Trial of Low-dose Radiation Therapy in Patients With Knee Osteoarthritis (LoRD-KNeA Trial)
Official title: A Multi-center, Randomized, Single-blinded, Exploratory Clinical Trial to Evaluate Safety and Efficacy of Alleviating Symptom of Low-dose RaDiation Therapy in Patients With KNee osteoArthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
Osteoarthritis
radiation therapy
radiotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: SMG-SNU Boramae Medical Center
name: Korea Hydro & Nuclear Power
First posted: 2022-09-30
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy

Detailed description: This clinical trial is a multicenter, randomized, single-blinded, exploratory clinical trial to evaluate the efficacy and safety of low-dose radiation for knee osteoarthritis patients. The experimental group is treated with low-dose irradiation 6 times for 3 weeks according to the dose determined for each group, and the control group is treated with sham irradiation. Both the experimental group and the control group visit the hospital 4 weeks after irradiation and at 4, 8, and 12 months to evaluate the efficacy and safety.

Eligibility criteria: 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/hyaluronic acid injection within 2 months of screening
* Patients with hip degenerative arthritis or other diseases of NRS 5 or higher that may affect functional score evaluation
* Patients who are scheduled for surgical treatment of the knee joint during the clinical trial period
* BMI \> 39 kg/m2
* Known history of analgesic or substance abuse within 2 years of screening
* History, diagnostic signs or symptoms of any of the following clinically significant psychiatric disorders that would render the study ineligible (psychotic disorder, depression, somatic disorder)
* History, diagnostic signs, or symptoms of any of the following clinically significant heart diseases that would render the study ineligible (surgery or stenting for ischemic heart disease and coronary artery disease within 6 months prior to screening)
* History of other diseases that may affect the index joint, including autoimmune diseases (lupus, rheumatoid arthritis, etc.)
* Fibromyalgia history or diagnosis
* If the researcher judges that a person with significant trauma or other findings considered clinically important is inappropriate for participation in this study

Primary outcomes:
measure: OMERACT-OARSI response rate
timeFrame: 4 months
Secondary outcomes:
measure: OMERACT-OARSI response rate
timeFrame: 4 weeks, 8 months, 12 months
measure: Changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
timeFrame: 4 weeks, 4 months, 8 months, 12 months
measure: Changes in pain score
timeFrame: 4 weeks, 4 months, 8 months, 12 months
measure: Changes in global assessment
timeFrame: 4 weeks, 4 months, 8 months, 12 months
measure: Radiological Changes Evaluated by Knee MRI
timeFrame: 4 months, 12 months
measure: Radiological Changes Evaluated by Knee X-ray
timeFrame: 12 months
measure: Changes in serum ESR (Erythrocyte sedimentation rate)
timeFrame: 4 weeks, 4 months, 8 months, 12 months
measure: Changes in serum CRP (C-reactive protein)
timeFrame: 4 weeks, 4 months, 8 months, 12 months
measure: Change in the amount of analgesic rescue medication usage
timeFrame: 4 weeks, 4 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Byoung Hyuck Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: