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The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose radiotherapy (LDRT) | Experimental | Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis. |
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| Corticosteroid injection (CSI) | Active Comparator | Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid injection (CSI) | Drug | A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) score | Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. | Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cochin Hand Function Scale scores | The Cochin Hand Function Scale (CHFS) uses an 18-item, 5-point Likert scale (0 to 5) for scoring, where higher scores indicate greater difficulty with hand function. Scores range from 0 (no difficulty) to 90 (impossible to complete) by summing the ratings for all 18 items. This scale measures the ability to perform daily activities related to the hand, such as kitchen tasks, dressing, and hygiene. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tochukwu Iyke-Nzeocha | Contact | (507) 422-3201 | Iyke-Nzeocha.Tochukwu@mayo.edu | |
| Melissa Wang, M.A., CCRP | Contact | (507) 266-6911 | wang.melissa@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Terin Sytsma, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D008775 | Methylprednisolone |
| D008012 | Lidocaine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
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| Low-dose radiotherapy (LDRT) | Radiation | Subjects will be treated with low-dose radiotherapy of 300cGy in 6 fractions, 2-3 times per week on non-consecutive days. Non-responders to the initial LDRT treatment will receive a second treatment course of 300cGy in 6 fractions to be given 2-3 times per week on non-consecutive days. |
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| Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention |
| Change in analgesic medication use | Change in analgesic medication use will be assessed using the Qualitative Analgesic Questionnaire [QAC]. The QAC is a 3 question self-report survey tracking current use of pain medications. | Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention |
| Patient experience, as measured by Was It Worth It questionnaire | The Was It Worth It questionnaire is a 4-question survey consisting of yes/no questions regarding the treatment experience. The greater number of questions with a 'yes' response indicate a higher level of patient satisfaction. | 6 months and 12 months post-intervention |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013812 | Therapeutics |