Clinical Trial of Low-Dose Radiotherapy for Knee Osteoarthritis

Overview

About this study

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain and functional limitations of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.  

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • age 50-85 years.
  • ICOAP pain scale A1 at least moderate intensity or B6 at least moderate intensity.
  • diagnosed with primary knee osteoarthritis 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 2-4 on knee x-rays taken within the last year.
  • ability to complete surveys in English.

Exclusion Criteria:

  • Kellgren-Lawrence grade 1.
  • 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 (may use during trial up to x doses per week and y days per week).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/16/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Merry, M.D.

Contact us for the latest status

Contact information:

Renee Weatherly

(507) 422-6823

weatherly.renee@mayo.edu

More information

Publications

Publications are currently not available