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 volunteersQualifiers
• patient's primary care provider is at Mayo Clinic in Rochester, MN
age 50-100 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
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Low dose radiotherapy
RadiationParticipants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device.
Sham comparator
Other interventionParticipants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Low dose radiotherapyActive comparator 1 intervention
Group B: PlaceboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov