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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.
Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGChange 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
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