Recruiting NCT07217405

Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

Phase IV Interventional Osteoarthritis Hand Osteoarthritis Wrist

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Corticosteroid injection (CSI), Low-dose radiotherapy (LDRT).
Who it may be relevant to: Registry conditions: Osteoarthritis Hand, Osteoarthritis Wrist. Basic parameters: from 50 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Low-Dose Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.

Drug 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 m
Radiation 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.

Change in Visual Analog Scale (VAS) score [Time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention]

Secondary outcome measures (3)

Change in Cochin Hand Function Scale scores [Time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention]
Change in analgesic medication use [Time frame: 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 [Time frame: 6 months and 12 months post-intervention]

Patient at Mayo Clinic, Rochester, MN
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

History of previous surgery to the affected hand(s)
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07217405 · 24-010252