Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

NCT ID: NCT06887829

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-06-29

Brief Summary

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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.

Detailed Description

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This single center, single-blinded, sham-controlled randomized controlled trial will compare low dose radiation therapy and sham radiation therapy for knee osteoarthritis. Participants with symptomatic knee OA based on clinical and radiographic criteria will be randomized 1:1 to receive 0.5 Gy LDRT over 2 weeks ideally on a Monday-Wednesday-Friday three times each week for two weeks treatment course for a total of 3 Gray or identical sham treatment (an identical procedure without the radiation). Non-responders to the initial Low-Dose Radiotherapy (LDRT)/sham treatment will receive a second treatment course of 0.5 Gy Low-Dose Radiotherapy (LDRT) or sham repeat treatment course over 2 weeks x 6 depending on their randomization (treatment arm participants receiving a second treatment course and sham arm participants receiving a second course of identical sham treatments without radiation). Intermittent and Constant Osteoarthritis Pain (ICOAP) outcome scales will be emailed to all participants for completion at baseline and weekly for six months. The study will thus terminate after all participants have completed 6 months of time in the study.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low dose radiotherapy

Low dose radiation therapy for knee osteoarthritis

Group Type ACTIVE_COMPARATOR

Low dose radiotherapy

Intervention Type RADIATION

Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.

Placebo

No radiation therapy

Group Type SHAM_COMPARATOR

Sham comparator

Intervention Type OTHER

Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.

Interventions

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Low dose radiotherapy

Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.

Intervention Type RADIATION

Sham comparator

Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Stephen P. Merry

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen P. Merry, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Paul D. Brown, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Family Medicine Research Study Coordinators

Role: CONTACT

507-422-6823

Facility Contacts

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Family Medicine Research Study Coordinators

Role: primary

507-422-6823

Other Identifiers

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24-006759

Identifier Type: -

Identifier Source: org_study_id

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