Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06887829
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Low dose radiotherapy — RADIATION
    Low-Dose Radiation Therapy (LDRT) delivered at 0.5 Gy per fraction for 6 fractions, administered on a Monday-Wednesday-Friday schedule over 2 weeks, for a total cumulative dose of 3 Gy. Delivered to the more symptomatic (index) knee. Participants who report no improvement in knee pain at their 2-month assessment will receive a second identical round of LDRT (totaling an additional 3 Gy).
  • Sham comparator — OTHER
    An identical sham procedure without radiation delivery, administered to the more symptomatic (index) knee on a Monday-Wednesday-Friday schedule over 2 weeks (6 sessions total). Participants who report no improvement in knee pain at their 2-month assessment will receive a second identical round of the sham procedure.

Study Details

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.

Key Dates

First listed
Mar 20, 2025
Start date
Jun 4, 2025
Status verified
Aug 2026
Primary completion
Jun 28, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low dose radiotherapy
    Low dose radiotherapy for knee osteoarthritis
  • Sham Comparator: Placebo
    No radiation therapy

Primary Outcome Measure

Change in Area Under the Curve (AUC) of ICOAP Scores [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Family Medicine Research Study Coordinators
[email protected]
507-422-6823

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MN

Related Studies