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

Knee Osteoarthritis Clinical Trial

— LoRD-KNeA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562271
• Other study ID #: N22S005000
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: August 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Radiation:
• low-dose radiation therapy
low-dose radiation therapy to involved knee joint
• sham radiation therapy
sham radiation therapy to involved knee joint

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital / SMG-SNU Boramae Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Hydro & Nuclear Power, Samsung Medical Center, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OMERACT-OARSI response rate	OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 weeks, 8 months, and 12 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 weeks, 8 months, 12 months
Secondary	Changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score	Total score (min 0, max 96 points, higher scores mean a worse outcome) and WOMAC score subscale (pain: min 0 max 20, stiffness: min 0 max 8, physical function: min 0 max 68)	4 weeks, 4 months, 8 months, 12 months
Secondary	Changes in pain score	VAS score (min 0, max 100, higher scores mean a worse outcome)	4 weeks, 4 months, 8 months, 12 months
Secondary	Changes in global assessment	PGA (Patient Global Assessment) score (min 0, max 100, higher scores mean a worse outcome)	4 weeks, 4 months, 8 months, 12 months
Secondary	Radiological Changes Evaluated by Knee MRI	Radiological Changes Evaluated by Knee MRI	4 months, 12 months
Secondary	Radiological Changes Evaluated by Knee X-ray	Radiological Changes Evaluated by Knee X-ray	12 months
Secondary	Changes in serum ESR (Erythrocyte sedimentation rate)	Changes in ESR (Erythrocyte sedimentation rate)	4 weeks, 4 months, 8 months, 12 months
Secondary	Changes in serum CRP (C-reactive protein)	Changes in CRP (C-reactive protein)	4 weeks, 4 months, 8 months, 12 months
Secondary	Change in the amount of analgesic rescue medication usage	Concomitant use of analgesics is prohibited until 4 months after irradiation, when the primary efficacy evaluation is scheduled. During this period, the use of a rescue drug (acetaminophen) may be permitted if the subjects need it for osteoarthritis. Monitor the amount of rescue medication prescribed to measure changes in usage during visits up to 4 months	4 weeks, 4 months