Clinical Trial of Low-dose Radiation Therapy in Patients With Knee Osteoarthritis (LoRD-KNeA Trial)

NCT ID: NCT05562271

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2025-09-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sham radiation therapy

sham radiation therapy

Group Type: SHAM_COMPARATOR

sham radiation therapy

Intervention Type: RADIATION

sham radiation therapy to involved knee joint

low-dose radiation therapy, 30 cGy/6 fx (experimental 1)

low-dose radiation therapy, 30 cGy/6 fx

Group Type: EXPERIMENTAL

low-dose radiation therapy

Intervention Type: RADIATION

low-dose radiation therapy to involved knee joint

low-dose radiation therapy, 300 cGy/6 fx (experimental 2)

low-dose radiation therapy, 300 cGy/6 fx

Group Type: EXPERIMENTAL

low-dose radiation therapy

Intervention Type: RADIATION

low-dose radiation therapy to involved knee joint

Interventions

low-dose radiation therapy

low-dose radiation therapy to involved knee joint

Intervention Type: RADIATION

sham radiation therapy

sham radiation therapy to involved knee joint

Intervention Type: RADIATION

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Korea Hydro & Nuclear Power

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Byoung Hyuck Kim

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byoung Hyuck Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

Seoul National University Hospital / SMG-SNU Boramae Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Kim BH, Shin K, Kim MJ, Kim HJ, Ro DH, Wang JH, Lee DH, Kim DH, Sun J, Lee JH, Kim JY, Hong EH, Cho SJ, Han HS, Park W. Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial. BMJ Open. 2023 Feb 10;13(2):e069691. doi: 10.1136/bmjopen-2022-069691.

Reference Type: DERIVED

PMID: 36764712 (View on PubMed)

Other Identifiers

N22S005000

Identifier Type: -

Identifier Source: org_study_id