Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

ConditionOsteoarthritis, Knee

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-100

SponsorMayo Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

128 Participants

are divided into 2 treatment groups

Group A: Low dose radiotherapyActive comparator 1 intervention

Group B: PlaceboSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Area Under the Curve (AUC) of ICOAP Scores

Change in the Intermittent and Constant Osteoarthritis Pain (ICOAP) outcome scale weekly for six months after intervention analyzed as area under the curve of patients with Kellgren-Lawrence grade 2-3 knee OA.

Time frame

Baseline, 6 months

Analgesic use frequency in treatment vs. sham participants

Differences in the rate of improvement between the 2 groups with analysis to include time points of 2 months and 4 months after intervention.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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