Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

NCT07217405 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-010252
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis Hand; Osteoarthritis Wrist

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Cochin Hand Function Scale scores

  Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention

• Change in analgesic medication use

  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

  6 months and 12 months post-intervention

Study Arms (2)

Low-dose radiotherapy (LDRT)

EXPERIMENTAL

Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.

Radiation: Low-dose radiotherapy (LDRT)

Corticosteroid injection (CSI)

ACTIVE COMPARATOR

Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.

Drug: Corticosteroid injection (CSI)

Interventions

Corticosteroid injection (CSI) DRUG

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

Also known as: Methylprednisolone, Lidocaine

Corticosteroid injection (CSI)

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.

Low-dose radiotherapy (LDRT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Adrenal Cortex Hormones; Methylprednisolone; Lidocaine; Radiotherapy

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics

Study Officials

• Terin Sytsma, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 16, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)