Radiotherapy for Osteoarthritis

Overseen By Family Medicine Research Study Coordinators

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opiate analgesics

Disqualifiers: Pregnancy, Knee surgery, Inflammatory arthritis, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether low-dose radiotherapy can reduce knee pain in individuals with osteoarthritis, a condition causing joint pain and stiffness. Researchers aim to determine if this treatment is more effective than a placebo (a treatment with no active effect) and if it causes any side effects. Ideal participants have a diagnosis of knee osteoarthritis, experience significant pain, and have morning stiffness in their knees lasting less than 30 minutes. As an unphased trial, this study provides participants the chance to contribute to innovative research that could lead to new treatment options for osteoarthritis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly use opiate painkillers, PRP, or acupuncture for your knees.

What prior data suggests that low-dose radiotherapy is safe for treating knee osteoarthritis?

Research has shown that low-dose radiotherapy for knee osteoarthritis is generally safe and well-tolerated. Most studies report only mild side effects, such as skin redness or slight tiredness. No reports of serious side effects, meaning nothing severe or life-threatening, have been linked to this treatment. While the treatment is being tested for its ability to reduce pain, its safety appears promising based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low dose radiotherapy for osteoarthritis because it offers a new approach distinct from standard treatments like painkillers and physical therapy. Unlike typical treatments that primarily focus on managing symptoms, low dose radiotherapy targets the inflammation at the cellular level, potentially providing longer-lasting relief. Additionally, this method is non-invasive, making it an appealing alternative for those who may not respond well to medications or are looking to avoid surgery.

What evidence suggests that low-dose radiotherapy might be an effective treatment for knee osteoarthritis?

Research suggests that low-dose radiotherapy, which participants in this trial may receive, might help reduce pain in people with knee osteoarthritis. Some studies have shown that this treatment led to less pain and better movement in patients with mild to moderate symptoms. One study found that a single session of low-dose radiotherapy resulted in noticeable improvements in pain and physical function. However, a meta-analysis suggested that this treatment might not be much better than a placebo (a fake treatment) for osteoarthritis. While there's promising evidence, the effectiveness of low-dose radiotherapy for knee osteoarthritis remains unclear. ^{1 2 6 7 8}

Who Is on the Research Team?

Paul D. Brown, M.D.

Principal Investigator

Mayo Clinic

Stephen P. Merry, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who are experiencing pain. Specific eligibility criteria aren't provided, but typically participants should be adults meeting diagnostic criteria for the condition and able to comply with study requirements.

Inclusion Criteria

I don't have knee pain in specific tendon areas.

My knees are stiff in the morning for less than 30 minutes.

My knee x-rays show moderate arthritis.

Exclusion Criteria

Kellgren-Lawrence grade 1 or 4

My current knee pain was caused by an injury within the last year.

History of psychosis, personality disorder, uncontrolled affective disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 0.5 Gy low-dose radiotherapy or sham treatment over 2 weeks, ideally on a Monday-Wednesday-Friday schedule

2 weeks

3 visits per week (in-person)

Second Treatment Course

Non-responders receive a second course of 0.5 Gy low-dose radiotherapy or sham treatment over 2 weeks

2 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using ICOAP outcome scales

6 months

Weekly assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Low dose radiotherapy

Trial Overview The trial is testing if low-dose radiotherapy can reduce knee pain from osteoarthritis compared to a sham (fake) treatment. Participants will be randomly assigned to receive either the real or sham therapy to assess effectiveness and side effects.

How Is the Trial Designed?

Group I: Low dose radiotherapy Active Control 1 Intervention

Low dose radiation therapy for knee osteoarthritis

Group II: Placebo Placebo Group 1 Intervention

No radiation therapy

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/low-dose-radiation-therapy-offers-substantial-relief-to-people-with-painful-knee-osteoarthritis

Low-dose radiation therapy offers substantial relief to ... The study showed patients with mild to moderate knee osteoarthritis reported significant reductions in pain and improved physical function in ...

2. redjournal.org redjournal.org/article/S0360-3016(25)06165-6/fulltext

Short-term Results from the Randomized, Sham-Controlled ... A single course of 3 Gy LDRT led to significant improvement in clinical outcomes for patients with mild-to-moderate knee OA. These findings support its ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625061656

LBA 06 Clinical Effectiveness of Single Course Low-Dose ... Conclusion. A single course of 3 Gy LDRT led to significant improvement in clinical outcomes for patients with mild-to-moderate knee OA. These findings support ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40888940/

Efficacy, safety, and pain management of low-dose ... Conclusion: This meta-analysis found that low-dose radiotherapy (LDRT) offers no significant benefit over sham treatment for osteoarthritis in ...

5. auntminnie.com auntminnie.com/clinical-news/radiation-oncology-therapy/article/15768155/astro-lowdose-rt-effective-for-treating-knee-osteoarthritis

ASTRO: Low-dose RT effective for treating knee osteoarthritis Research presented at ASTRO 2025 showed the effectiveness of low-dose radiation therapy for treating knee osteoarthritis.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0011393X25000025

Low-dose Radiation Therapy (LDRT) in Managing ... LDRT is mostly considered as a safe and well-tolerated treatment, with only a few reports of mild adverse effects. Only nonserious adverse events (NSAE), such ...

7. redjournal.org redjournal.org/article/S0360-3016(22)00357-1/fulltext

The Use of Low-Dose Radiation Therapy in Osteoarthritis Numerous recent studies published outside the US have shown moderate to long-term pain relief and improvement of mobility after treatment with LDRT for joints ...

8. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30096-7/abstract

Long-term efficacy of low-dose radiation therapy on ... No substantial effects of low-dose radiation therapy on clinical outcomes were seen in patients with knee and hand osteoarthritis.