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?

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.

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.

Is low-dose radiotherapy safe for treating osteoarthritis?

There is limited information on the safety of low-dose radiotherapy for osteoarthritis, as most studies are of low quality and do not report side effects. More high-quality research is needed to confirm its safety. ^{1 2 3 4 5}

How does low-dose radiotherapy differ from other treatments for osteoarthritis?

Low-dose radiotherapy (LDRT) is unique because it is a noninvasive treatment that uses low levels of radiation to reduce pain and improve mobility in osteoarthritis patients, particularly in Germany and Eastern Europe. Unlike typical pain medications or surgical options, LDRT is cost-effective and has minimal side effects, though its use is less common in the United States. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Low dose radiotherapy for osteoarthritis?

Some studies suggest that low-dose radiotherapy may help reduce pain in patients with severe osteoarthritis of the hip or knee, as seen in a cohort study and literature review. However, other research, like a trial on hand osteoarthritis, found no significant benefits, indicating mixed results on its effectiveness. ^{1 6 7 9 10}

Who Is on the Research Team?

Stephen P. Merry, M.D.

Principal Investigator

Mayo Clinic

Paul D. Brown, 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. Germany pubmed.ncbi.nlm.nih.gov

ArthroRad trial: randomized multicenter single-blinded trial on the effect of low-dose radiotherapy for painful osteoarthritis-final results after 12-month follow-up. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Short-term pain reduction after low-dose radiotherapy in patients with severe osteoarthritis of the hip or knee joint: a cohort study and literature review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of low-dose radiotherapy in painful gonarthritis: experiences from a retrospective East German bicenter study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

ArthroRad trial: multicentric prospective and randomized single-blinded trial on the effect of low-dose radiotherapy for painful osteoarthritis depending on the dose-results after 3 months' follow-up. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Low-dose radiotherapy for painful osteoarthritis of the elderly: A multicenter analysis of 970 patients with 1185 treated sites. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The efficacy and safety of low-dose radiotherapy on pain and functioning in patients with osteoarthritis: a systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of low-dose radiation therapy on symptoms in patients with knee osteoarthritis: a randomised, double-blinded, sham-controlled trial. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Low-dose radiation therapy for osteoarthritis and enthesopathies: a review of current data. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Use of Low-Dose Radiation Therapy in Osteoarthritis: A Review. [2022]