Low-dose radiation treatment for knee osteoarthritis
The Randomized Clinical Trial of Low-Dose Radiotherapy for Knee Osteoarthritis
This trial will test whether low-dose radiotherapy reduces pain in people aged 50–85 with symptomatic knee osteoarthritis compared with a sham procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06887829 on ClinicalTrials.gov |
What this trial studies
This single-center, single-blinded, randomized, sham-controlled trial at Mayo Clinic will compare low-dose radiotherapy (0.5 Gy given three times per week for two weeks, total 3 Gy) with an identical sham procedure in patients with symptomatic knee osteoarthritis. Participants who do not respond to the initial course may receive a second identical course (active or sham) according to their randomization. Pain outcomes are measured with the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale collected weekly for six months. The study ends after all participants complete six months of follow-up.
Who should consider this trial
Good fit: Adults aged 50–85 with symptomatic primary knee osteoarthritis (Kellgren‑Lawrence grade 2–3) and at least moderate pain on the ICOAP scale are ideal candidates.
Not a fit: Patients with very mild (KL grade 1) or severe end-stage (KL grade 4) osteoarthritis, inflammatory or tendon-related knee pain, pregnant women, or those unable to travel to Mayo Clinic are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a non-surgical option to reduce knee pain and improve quality of life for patients with moderate osteoarthritis.
How similar studies have performed: Smaller randomized and observational studies, mainly from European centers, have reported pain relief with low-dose radiotherapy for osteoarthritis but results are mixed and not yet widely adopted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 50-85 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 * history of morning stiffness in knees that lasts less than 30 minutes * history of crepitus without a history of warmth, redness or sudden onset of swelling * physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain for which their primary care provider has ordered an intraarticular steroid injection into the same knee. * absence of primary knee pain in the pes anserine or hamstring or gastrocnemius tendons * radiographic Kellgren-Lawrence grade 2-3 on 4-view knee x-rays taken within the last year * ability to complete surveys in English Exclusion Criteria: * Kellgren-Lawrence grade 1 or 4 * pregnancy or women 54 years and younger with potential for pregnancy (if they or their partner have not had tubal ligation, hysterectomy, or vasectomy) * history of ipsilateral intraarticular knee surgery * use of injected corticosteroids within 3 months or hyaluronans within 6 months or within 1 month if there was no sustained improvement post-injection of either corticosteroid or hyaluronan. * history of trauma to this knee in the last year that clearly caused the pain now present * history of RA, gout, pseudogout, hemarthroses (eg, hemophilic arthropathy) or other inflammatory arthritis involving this knee * history of symptomatic hip OA * history of psychosis, personality disorder, uncontrolled affective disorder * history of fibromyalgia * malignancy requiring active treatment * current regular use of opiate analgesics, PRP, or acupuncture for the knees
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Stephen P. Merry, M.D. — Mayo Clinic
- Study coordinator: Family Medicine Research Study Coordinators
- Email: RSTFMSC@mayo.edu
- Phone: 507-422-6823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.