Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

Mayo Clinic128 enrolled

Overview

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.

This is a single-center, single-blinded, sham-controlled, superiority randomized controlled trial at Mayo Clinic, Rochester, Minnesota. A total of 128 adults aged 50-100 years with primary knee OA, Kellgren-Lawrence (KL) grade 2-3, and at least moderate pain will be randomized 1:1 to receive either low dose radiotherapy (LDRT) to the affected knee or an identical sham procedure. LDRT will be delivered at 0.5 Gray (Gy) per fraction x 6 fractions (3 Gy total, delivered over 2 weeks). Non-responders at 2 months will receive an identical second course according to the original allocation. The primary endpoint is the area under the curve (AUC) of the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale collected weekly for 6 months. Secondary and exploratory endpoints include analgesic use, durability of response at 9 and 12 months, and effect modification by age and body mass index. The trial has 80% power (two-sided alpha level of 0.05) to detect a half-standard-deviation difference in AUC between groups on the ICOAP scale over 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Osteoarthritis, Knee

Interventions

Low dose radiotherapyRADIATION

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 comparatorOTHER

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

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

Central Contacts

Family Medicine Research Study Coordinators

CONTACT

507-422-6823 RSTFMSC@mayo.edu

Data from ClinicalTrials.gov

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