Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
NCT ID: NCT07217405
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
165 participants
INTERVENTIONAL
2025-12-23
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-dose radiotherapy (LDRT)
Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.
Low-dose radiotherapy (LDRT)
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.
Corticosteroid injection (CSI)
Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.
Corticosteroid injection (CSI)
A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine:
* 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\*
* Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine\*
* Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\*
* Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine
* Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 mL 1% lidocaine
Interventions
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Corticosteroid injection (CSI)
A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine:
* 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\*
* Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine\*
* Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\*
* Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine
* Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 mL 1% lidocaine
Low-dose radiotherapy (LDRT)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 50 years or older
* Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months
* Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand
* Ability to complete study questionnaires
Exclusion Criteria
* Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis
* Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture
* Recent injury (within last 1 month) to the affected hand causing current pain
* History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s)
* Active use of opioid pain medication(s) or oral steroids within the last 3 months
* Fibromyalgia or central sensitization syndrome
* Hand CSI or other hand injection within the past 3 months
* History of hand LDRT within the past 3 months
* Poorly controlled diabetes (HbA1c \> 10%)
* Active infection
* Current pregnancy
50 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Terin T. Sytsma
Principal Investigator
Principal Investigators
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Terin Sytsma, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Department of Medicine Research Hub
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-010252
Identifier Type: -
Identifier Source: org_study_id