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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose radiotherapy | Active Comparator | Low dose radiation therapy for knee osteoarthritis |
|
| Placebo | Sham Comparator | No radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose radiotherapy | Radiation | Participants will receive low dose radiotherapy (0.5 Gy) 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
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Inclusion Criteria:
• 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
o You have not had recurrent episodes of sudden onset of warmth, redness, or swelling of the affected knee
physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain.
absence of primary knee pain in the pes anserine or hamstring or gastrocnemius, quadriceps, or patellar tendons on exam.
radiographic Kellgren-Lawrence grade 2-3 on 4-view knee x-rays taken within the last year ability to complete surveys electronically by email
Exclusion Criteria:
• Kellgren-Lawrence grade 1 or 4
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Family Medicine Research Study Coordinators | Contact | 507-422-6823 | RSTFMSC@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen P. Merry, M.D. | Mayo Clinic | Principal Investigator |
| Paul D. Brown, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sham comparator | Other | Participants will receive identical treatment 3 times per week, for two weeks delivered via the X-Strahl Orthovoltage device, without radiation. |
|
| D012216 |
| Rheumatic Diseases |