Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

Not Applicable

Recruiting

• Conditions: Osteoarthritis Hand; Osteoarthritis Wrist
• Interventions: Radiation: Low-dose radiotherapy (LDRT); Drug: Corticosteroid injection (CSI)

• Registration Number: NCT07217405
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-14
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-16
• Last Update Posted: 2025-10-16
• Study Start: 2025-11-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose radiotherapy (LDRT)	Low-dose radiotherapy (LDRT)	Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.
Corticosteroid injection (CSI)	Corticosteroid injection (CSI)	Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) score	Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in Cochin Hand Function Scale scores	Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention	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.
Change in analgesic medication use	Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention	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.
Patient experience, as measured by Was It Worth It questionnaire	6 months and 12 months post-intervention	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States