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Knee OsteoarthritisLoRD-KNeANCT05562271

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

A study testing low-dose radiation therapy in people with Knee Osteoarthritis, run by Seoul National University Hospital at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
low-dose radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
3 sitesSouth Korea
Study dates
28 Oct 2022to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Seoul National University Hospital / SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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

Read the 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.

Being tested
low-dose radiation therapy, sham radiation therapy
Keywords
knee, Osteoarthritis, radiation therapy, radiotherapy
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-dose radiation therapyRadiation

    low-dose radiation therapy to involved knee joint

  • sham radiation therapyRadiation

    sham radiation therapy to involved knee joint

Study groups in NCT05562271
Study groupRoleWhat they receive
sham radiation therapySham comparatorsham radiation therapy
Receives: Radiation: sham radiation therapy
low-dose radiation therapy, 30 cGy/6 fx (experimental 1)Experimentallow-dose radiation therapy, 30 cGy/6 fx
Receives: Radiation: low-dose radiation therapy
low-dose radiation therapy, 300 cGy/6 fx (experimental 2)Experimentallow-dose radiation therapy, 300 cGy/6 fx
Receives: Radiation: low-dose radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (9)

  1. 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.

    Measured: 4 weeks, 8 months, 12 months

  2. 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)

    Measured: 4 weeks, 4 months, 8 months, 12 months

  3. Changes in pain score

    VAS score (min 0, max 100, higher scores mean a worse outcome)

    Measured: 4 weeks, 4 months, 8 months, 12 months

  4. Changes in global assessment

    PGA (Patient Global Assessment) score (min 0, max 100, higher scores mean a worse outcome)

    Measured: 4 weeks, 4 months, 8 months, 12 months

  5. Radiological Changes Evaluated by Knee MRI

    Radiological Changes Evaluated by Knee MRI

    Measured: 4 months, 12 months

  6. Radiological Changes Evaluated by Knee X-ray

    Radiological Changes Evaluated by Knee X-ray

    Measured: 12 months

  7. Changes in serum ESR (Erythrocyte sedimentation rate)

    Changes in ESR (Erythrocyte sedimentation rate)

    Measured: 4 weeks, 4 months, 8 months, 12 months

  8. Changes in serum CRP (C-reactive protein)

    Changes in CRP (C-reactive protein)

    Measured: 4 weeks, 4 months, 8 months, 12 months

  9. 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

    Measured: 4 weeks, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study start28 Oct 2022
  3. Primary completion25 Jul 2024
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05562271
Sponsor's protocol ID
N22S005000
Acronym
LoRD-KNeA
Status last verified
Mar 2026
First submitted
22 Sep 2022
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36764712

Questions about this trial

What is this clinical trial studying?

A study testing low-dose radiation therapy in people with Knee Osteoarthritis, run by Seoul National University Hospital at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OMERACT-OARSI response rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05562271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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