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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low-dose radiotherapy (LDRT) 		Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.
  • 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.
Active Comparator
Corticosteroid injection (CSI) 		Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand 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 mL 1% lidocaine
    Other names:
    • Methylprednisolone
    • Lidocaine

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Tochukwu Iyke-Nzeocha
(507) 422-3201
iyke-nzeocha.tochukwu@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Tochukwu Iyke-Nzeocha
(507) 422-3201
Iyke-Nzeocha.Tochukwu@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.