Radiotherapy vs Corticosteroid Injection for Osteoarthritis

Overseen By Department of Medicine Research Hub

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids, Oral steroids

Disqualifiers: Rheumatoid arthritis, Psoriatic arthritis, Fibromyalgia, Diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 treatments

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment is more effective for hand and wrist osteoarthritis: low-dose radiotherapy or corticosteroid injections. Osteoarthritis leads to joint pain and stiffness, and the trial will compare these options to assess which relieves symptoms more effectively. Participants will receive either six sessions of low-dose radiotherapy or standard corticosteroid injections. Suitable candidates have experienced hand osteoarthritis pain for the past two years and are patients at Mayo Clinic in Rochester, MN. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, and the trial seeks to understand how they benefit more patients.

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 have used opioid pain medications or oral steroids in the last 3 months.

What is the safety track record for these treatments?

Research has shown that low-dose radiotherapy (LDRT) is safe for treating osteoarthritis. In one study, patients who received LDRT experienced no negative effects, even with repeated treatments. Another study found that LDRT helps relieve pain and improve movement without major side effects. Experts believe the risk of developing another cancer from these low doses is very low.

Corticosteroid injections are already a common treatment for osteoarthritis. Doctors are familiar with their risks and side effects. Generally, most people tolerate these injections well without serious problems. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about low-dose radiotherapy (LDRT) for osteoarthritis because it offers a unique approach compared to the standard corticosteroid injections. While corticosteroids reduce inflammation by suppressing the immune system, LDRT uses targeted radiation to reduce pain and inflammation at the cellular level without the need for pharmaceuticals. This method may potentially pose fewer systemic side effects and could provide longer-lasting relief. This innovative approach gives hope for a more sustainable and gentle treatment for those suffering from hand osteoarthritis.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research has shown that low-dose radiotherapy (LDRT), one of the treatments in this trial, can reduce pain and improve joint movement in people with osteoarthritis. In one study, 94% of patients reported less pain after receiving LDRT. Another study found that 70% of patients experienced significant relief, compared to 42% who received a placebo. Corticosteroid injections, the other treatment option in this trial, are a common method to reduce pain and swelling in the joints. Both treatments appear promising, but this trial aims to directly compare their effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Terin Sytsma, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with hand or wrist osteoarthritis. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may be required to meet certain health conditions.

Inclusion Criteria

I am 50 years old or older.

My hand arthritis is confirmed by X-rays as mild, moderate, or severe.

My hand pain scores at least 40 out of 100 when I use it.

Exclusion Criteria

I currently have an infection.

I have had surgery on my hand(s) before.

I have an autoimmune joint disease like rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose radiotherapy or corticosteroid injection for hand osteoarthritis

6 treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly visits for 6 months, then at 9 and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid Injection
• Low-dose radiotherapy

Trial Overview The study aims to compare the effectiveness of low-dose radiotherapy (LDRT) versus corticosteroid injection (CSI) in treating hand/wrist osteoarthritis. It's designed to see which treatment provides better pain relief and joint function.

How Is the Trial Designed?

Group I: Low-dose radiotherapy (LDRT) Experimental Treatment 1 Intervention

Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.

Group II: Corticosteroid injection (CSI) Active Control 1 Intervention

Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964493/

Low-dose Radiation Therapy (LDRT) in Managing ... Patients with hand or knee OA experienced skin reactions, nail reactions, and fatigue after LDRT, with similar numbers to sham group. However, ...

2. 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 ...

3. 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 ... After four months, 70% of patients in the 3 Gy group met responder criteria, compared to 42% in the placebo group (p=0.014). Outcomes in the 0.3 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625004390

Low-Dose Radiation Therapy for Osteoarthritis: A ... Eighty percent of joints showed significant pain improvement (von Pannewitz score 0-2) at EOT, with 72% maintaining this at FU. Thirty-three percent of joints ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34585316/

Low-dose radiation therapy for hand osteoarthritis: shaking ... Results: With a median follow-up of 10.5 months (range 7.55-12.45), 94% reported an improvement in the pain, with a significant reduction in the ...

6. 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.

7. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/low-dose-radiation-therapy-reemerging-for-osteoarthritis

Low-Dose Radiation Therapy Reemerging for Osteoarthritis Treatment of arthritis with low-dose radiation therapy (LDRT) ... data suggest the risk of a secondary cancer with those doses is very low.