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NCT Number: NCT07217405

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.

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Key information

Conditions

Osteoarthritis Hand Osteoarthritis Wrist

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Methylprednisolone, Lidocaine

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.

Primary outcomes

  1. Change in Visual Analog Scale (VAS) score

    Time frame: 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 outcomes

  1. Change in Cochin Hand Function Scale scores

    Time frame: 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.

  2. Change in analgesic medication use

    Time frame: 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.

  3. Patient experience, as measured by Was It Worth It questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Wang, M.A., CCRP

CONTACT

[email protected]

(507) 266-6911

Tochukwu Iyke-Nzeocha

CONTACT

[email protected]

(507) 422-3201

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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