Recruiting

Low-Dose Radiotherapy

Sponsor:

Mayo Clinic

Code:

NCT06887829

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Low dose radiotherapy

Sham comparator

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Study ID

NCT06887829

Start date

Jun 4, 2025

Status verified date

Aug, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age 50-100 years with a Mayo Clinic Rochester primary care provider At least moderate constant (ICOAP item A1) or intermittent (ICOAP item B6) pain Diagnosis of primary knee OA (ICD-10 M17.x) without recurrent acute inflammatory flares Joint-line tenderness on examination co-localizes with the reported pain and without a primary extra-articular pain generator Radiographic KL grade 2-3 within the preceding year Ability to complete electronic surveys

Exclusion Criteria:

Pregnancy or childbearing potential without surgical sterilization Recent knee trauma is causing the current pain History of inflammatory arthritis or hemarthrosis Symptomatic hip OA KL grade 1 or 4 Uncontrolled psychiatric illness Prior ipsilateral intra-articular knee surgery Corticosteroid injection within 3 months or hyaluronic acid injection within 6 months in the ipsilateral knee (or 1 month if no sustained improvement after either) Fibromyalgia Active malignancy requiring treatment Regular current use of opioids, platelet-rich plasma, or acupuncture use for the knee

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low dose radiotherapy

Low dose radiotherapy for knee osteoarthritis

sham comparator: Placebo

No radiation therapy

Interventions

Low dose radiotherapy

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

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.

Primary outcome measure

  • Change in Area Under the Curve (AUC) of ICOAP Scores [ Time Frame: Baseline, 6 months ]
  • Analgesic use frequency in treatment vs. sham participants [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Family Medicine Research Study Coordinators

507-422-6823RSTFMSC@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Family Medicine Research Study Coordinators

507-422-6823RSTFMSC@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • osteoarthritis, knee
  • Radiotherapy
  • Randomized controlled trial
  • Pain Management
  • Placebos

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-02.