The Randomized Clinical Trial of Low-Dose Radiotherapy for Knee Osteoarthritis
Mayo Clinic
Summary
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.
Description
This single center, single-blinded, sham-controlled randomized controlled trial will compare low dose radiation therapy and sham radiation therapy for knee osteoarthritis. Participants with symptomatic knee OA based on clinical and radiographic criteria will be randomized 1:1 to receive 0.5 Gy LDRT over 2 weeks ideally on a Monday-Wednesday-Friday three times each week for two weeks treatment course for a total of 3 Gray or identical sham treatment (an identical procedure without the radiation). Non-responders to the initial Low-Dose Radiotherapy (LDRT)/sham treatment will receive a second tre…
Eligibility
- Age range
- 50–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • patient's primary care provider is at Mayo Clinic in Rochester, MN * age 50-100 years * ICOAP pain scale A1 at least moderate intensity or B6 at least moderate intensity * diagnosed with primary knee OA ICD-10 codes M17.x o You have not had recurrent episodes of sudden onset of warmth, redness, or swelling of the affected knee * physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain. * absence of primary knee pain in the pes anserine or hamstring or gastrocnemius, quadriceps, or patel…
Interventions
- RadiationLow dose radiotherapy
Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.
- OtherSham comparator
Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.
Location
- Mayo ClinicRochester, Minnesota