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

NCT05562271 | Completed FDA Device

• 1 other identifier: N22S005000
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

knee; Osteoarthritis; radiation therapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• OMERACT-OARSI response rate

  OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 months. The OMERACT-OARSI criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.

  4 months

Secondary Outcomes (9)

• OMERACT-OARSI response rate

  4 weeks, 8 months, 12 months

• Changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score

  4 weeks, 4 months, 8 months, 12 months

• Changes in pain score

  4 weeks, 4 months, 8 months, 12 months

• Changes in global assessment

  4 weeks, 4 months, 8 months, 12 months

• Radiological Changes Evaluated by Knee MRI

  4 months, 12 months

Study Arms (3)

sham radiation therapy

SHAM COMPARATOR

sham radiation therapy

Radiation: sham radiation therapy

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

EXPERIMENTAL

low-dose radiation therapy, 30 cGy/6 fx

Radiation: low-dose radiation therapy

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

EXPERIMENTAL

low-dose radiation therapy, 300 cGy/6 fx

Radiation: low-dose radiation therapy

Interventions

low-dose radiation therapy RADIATION

low-dose radiation therapy to involved knee joint

low-dose radiation therapy, 30 cGy/6 fx (experimental 1); low-dose radiation therapy, 300 cGy/6 fx (experimental 2)

sham radiation therapy RADIATION

sham radiation therapy to involved knee joint

sham radiation therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Korea Hydro & Nuclear Power: collaborator

Study Sites (3)

Seoul National University Hospital / SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36764712 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Byoung Hyuck Kim, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: October 28, 2022
• Primary Completion: July 25, 2024
• Study Completion: September 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)